Prostate Cancer
Conditions
Keywords
Prostate cancer, PRO-MERIT, Cancer vaccine, W_pro1, BioNTech SE, RNA, mCRPC, LPC, Cemiplimab, BNT112
Brief summary
Open-label, multicenter, dose titration and four-arm expansion trial to evaluate the safety, tolerability, immunogenicity, and preliminary efficacy of BNT112 cancer vaccine (BNT112) monotherapy or in combination with cemiplimab in patients with metastatic castration resistant prostate cancer (mCRPC: Part 1 and Part 2 Arms 1A and 1B) and in patients with high-risk, localized prostate cancer (LPC). As of February 2023, the trial only recruited LPC patients and no longer mCRPC patients.
Detailed description
* BNT112 consisted of messenger ribonucleic acid (mRNA \[or RNA\]) targeting 5 antigens expressed in de novo and metastatic prostate cancer that were separately complexed with liposomes to form serum-stable RNA lipoplexes (RNA-LPX). * The RNA molecules were immune-pharmacologically optimized for high stability, translational efficiency and presentation on major histocompatibility complex (MHC) class I and II molecules. The vaccine was intended for intravenous (IV) bolus injection. * The RNA-LPX cancer vaccine induced activation of both the adaptive immune system (vaccine antigen-specific CD8+/CD4+ T cell) as well as the innate immune system (TLR7 agonism of single-stranded RNA). The physiology of efficient induction, expansion and differentiation of antigen-specific T cells was associated with programmed death receptor-1 (PD-1) upregulation on these T cells. Thus, the cancer vaccine was expected to have a synergistic mechanism of action with anti-PD-1. * The step-up dose titration approach allowed for optimal dose management on an individual basis and accounted for inter- and intra-individual variability of the immune system. * In summary, the mechanism of action of BNT112 both in monotherapy and in combination with anti-PD-1 immune checkpoint inhibitor cemiplimab, together with carefully selected and refined clinical setting presented a unique opportunity for patients with different stages of prostate cancer.
Interventions
BIOLOGICALBNT112
Intravenous bolus injection
DRUGCemiplimab
Intravenous infusion
Sponsors
BioNTech SE
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients were male and aged \>=18 years. * Patients had histologically confirmed prostate adenocarcinoma. * Patients had an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1. Specific key inclusion criteria for mCRPC patients (Part 1 and Part 2 Arms 1A and 1B) - Recruitment of mCRPC patients now completed: * Patients had histologically confirmed mCRPC and had progressed after at least 2 but no more than 3 lines of life-prolonging systemic therapy (e.g., abiraterone or enzalutamide, docetaxel, cabazitaxel) or cannot tolerate or refused any of these therapies. These lines of therapy included life-prolonging therapies administered in the metastatic hormone-sensitive setting. * Prior surgical or chemical castration with a serum testosterone \<1.7 nmol/L (50 ng/dL). If the method of castration was luteinizing hormone-releasing hormone analogue (LHRHa), there was a plan to maintain effective LHRHa therapy for the duration of the trial. * Patients had documented mCRPC progression within 6 months prior to screening (assuming no subsequent change in treatments), as determined by the investigator. * Patients agreed to provide an archival pre-treatment formalin-fixed, paraffin-embedded tumor sample if available. Specific key inclusion criteria for newly diagnosed LPC patients (Part 2 Arms 2 and 3): * Treatment-naïve patients with LPC (i.e., N0, M0). According to risk levels of the European Association of Urology Guidelines on Prostate Cancer (2018), and in line with the U.S. National Comprehensive Cancer Network (NCCN 2020), patients had at least 1 of the following: 1. PSA \>20 ng/mL or 2. Gleason Score \>7 or 3. Localized stage \>=cT2c, N0, M0 according to tumor, node, metastasis classification. * Patients who intend to have and were suitable for a radical prostatectomy. * Patients agreed to provide tumor sample(s) from pre-treatment diagnostic biopsy and planned post-treatment surgery. Main
Exclusion criteria
for all patients: Medical conditions * Patients with uncontrolled intercurrent illness. * Patients with a known history or current malignancy other than the inclusion diagnosis. Note: Exceptions were patients with malignancies with a negligible risk of metastasis or death, that had been adequately treated, such as non-invasive basal cell or non-invasive squamous cell skin carcinoma, non-invasive, superficial bladder cancer, and any cancer with a complete response (CR) that lasted more than 2 years might be included. * Patients who had major surgery (e.g., requiring general anesthesia) within 4 weeks before screening, or have not fully recovered from surgery, or had a surgery planned during the time of trial participation, except for the radical prostatectomy planned for patients in Part 2 Arms 2 and 3. * Patients who had a known history of any of the following: 1. Human immunodeficiency virus (HIV) 1 or 2 2. Hepatitis B (carrier or active infection) 3. Hepatitis C (unless considered cured 5 years post curative anti-viral therapy) * Patients who have received or currently receive the following therapy/treatment: 1. Chronic systemic immunosuppressive corticosteroid treatment (prednisone \>5 mg daily orally \[PO\] or IV, or equivalent) during the trial. Note: Replacement therapy (e.g., physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is permitted. 2. Prior treatment with other immune modulating agents that was (a) within fewer than 4 weeks (28 days) or 5 half-lives (whichever is longer) prior to the first dose of cemiplimab, or (b) associated with immune-mediated AEs that were Grade \>=1 within 90 days prior to the first dose of cemiplimab, or (c) associated with toxicity that resulted in discontinuation of the immune-modulating agent. 3. Prior treatment with other immune modulating agents for any non-cancer disease within 4 weeks or 5 half-lives of the agent (whichever is longer) before the first dose of IMP. 4. Prior treatment with live-attenuated vaccines within 4 weeks before the first dose of IMP and during treatment with IMP. 5. Prior treatment with an investigational drug (including investigational vaccines) within 4 weeks or 5 half-lives of the agent (whichever is longer) before the planned first dose of IMP. 6. Therapeutic PO or IV antibiotics within 14 days prior to enrollment. Note: Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) might be enrolled. 7. Concurrent use of herbal products that might decrease PSA levels (e.g., saw palmetto). Specific key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) | Cycle 1 (21 days) | DLT criteria were defined as following: any treatment-emergent adverse events (TEAE) of Grade 5 intensity; hematological toxicities (Grade 3 and 4 febrile neutropenia, Grade 4 thrombocytopenia, Grade 3 and 4 hemorrhage associated with thrombocytopenia of Grade greater than or equal to \[\>=\] 3, Grade 4 anemia); and non-hematological toxicities (Grade 4 cytokine release syndrome \[CRS\], Grade 3 CRS which has not improved to Grade 1 or resolved within 48 hours; any Grade \>=3 non-hematological TEAE at least possibly related which occurs during the first BNT112 cancer vaccine treatment cycle). |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Related to Trial Procedure | From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arms 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month) | TEAE: any adverse event (AE) with an onset date on or after the first administration of investigational medicinal product (IMP) or worsened after first administration of IMP. AEs with an onset date more than 30 days after last dose of BNT112 or 90 days after last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) were only considered as TEAEs if assessed as related to IMP by the investigator. Serious adverse event (SAE): any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect or was another medically important condition. AEs were graded for severity using National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v5.0), where Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4 - Life-threatening consequences; Grade 5: Death related to AE. |
| Part 2 Arm 1a: Objective Response Rate (ORR) | From start of treatment up to 46 weeks | ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) as per Prostate Cancer Working Group 3 (PCWG3) criteria as determined by the investigator. Participants not meeting the criteria for CR or PR, including those without any post-baseline tumor assessments, were considered as non-responders. CR was defined as the disappearance of all target lesions, with a reduction in short axis to \<10 mm in any pathological lymph nodes and no new lesions. PR was defined as 30% decrease in the sum of the longest diameter of target lesions. |
| Part 2 Arm 1b: Objective Response Rate (ORR) | From start of treatment up to 104 weeks | ORR was defined as the percentage of participants with a CR or PR as per PCWG3 criteria as determined by the investigator. Participants not meeting the criteria for CR or PR, including those without any post-baseline tumor assessments, were considered as non-responders. CR was defined as the disappearance of all target lesions, with a reduction in short axis to \<10 mm in any pathological lymph nodes and no new lesions. PR was defined as 30% decrease in the sum of the longest diameter of target lesions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Day8 (Cycles1&2 only), Day1 Cycle 2 & Day 15 (Cycles1,2 & 8 only) (each cycle of 21-days), & EOT (30 days after last dose of BNT112 [Part 1 & Part 2 Arms 1b & 3] or 90 days after last dose of cemiplimab [Part 2, Arm 1a & Arm 2] [up to 4 years & 1 months]) | Participants blood samples were tested for levels of PSA to track the progression of prostate cancer. PSA decline categories of No decline, 0 to 25%, \>25% to 50%, and \>50% compared to baseline during treatment according to PCWG3 (as reported by the investigator) are reported in this outcome measure. EOT in the timeframe below refers to End of treatment. |
| Part 2: Arms 2 and 3: Number of Participants With Tumor Response Post-Treatment | From start of treatment up to 25 weeks (Arm 2) and up to 26 weeks (Arm 3) | The best overall response was defined as a single best response status at any tumor response assessment after first administration of IMP and prior to or at the start date of the first subsequent anti-cancer therapy. Overall response of progressive disease within 14 days after the start date of first subsequent anti-cancer therapy was considered. The following order of tumor response categories were used, where Complete Response is the best category: Complete Response (CR) - Partial Response (PR) - Stable Disease (SD) - Progressive Disease (PD) - Not Evaluable (NE) - Missing. CR: disappearance of all target lesions, with reduction in short axis to \<10 mm in any pathological lymph nodes and no new lesions. PR:30% decrease in the sum of the longest diameter of target lesions. PD: progression of target lesions (sum of diameter increase to nadir of \>=20% and by \>=5 mm), progression of existing non-target lesions, or appearance of 1 or more new lesions.SD: no evidence of PD, CR or PR. |
| Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1, Cycle 8 Day 1, Cycle 12 Day 1 (each cycle duration=21 days) | Participants blood samples were tested for levels of PSA to track the progression of prostate cancer. PSADT was calculated using a linear regression model of the natural logarithm of PSA values and time. PSA doubling time compared to baseline during the treatment period for the following categories: 0 - 3 months; \>3 - 6 months; \>6 - 9 months; \>9 - 12 months; \>12 - 18 months; \>18 - 24 months; \>24 months and declining are reported in this outcome measure. |
| Number of Participants With PSA Decline of >=50% | Day8 (Cycles1&2 only), Day1 Cycle 2 & Day 15 (Cycles1,2 & 8 only) (each cycle of 21-days), & EOT (30 days after last dose of BNT112 [Part 1 & Part 2 Arms 1b & 3] or 90 days after last dose of cemiplimab [Part 2, Arm 1a & Arm 2] [up to 4 years & 1 months]) | Participants blood samples were tested for levels of PSA to track the progression of prostate cancer. Participants with PSA decline of \>=50% compared to baseline according to PCWG3 (as reported by the investigator) are reported in this outcome measure. EOT in the timeframe below refers to End of treatment. |
| Part 1: Objective Response Rate (ORR) | From start of treatment up to 27 weeks | ORR was defined as the percentage of participants with a CR or PR as per PCWG3 criteria as determined by the investigator. Participants not meeting the criteria for CR or PR, including those without any post-baseline tumor assessments, were considered as non-responders. CR was defined as the disappearance of all target lesions, with a reduction in short axis to \<10 mm in any pathological lymph nodes and no new lesions. PR was defined as 30% decrease in the sum of the longest diameter of target lesions. |
Countries
Germany, Hungary, United Kingdom, United States
Participant flow
Recruitment details
The trial consisted of 2 parts: Part 1 (dose titration) and Part 2 (dose expansion; consisted of four arms).
Pre-assignment details
Part 1 and Part 2 (Arms 1A and 1B) enrolled participants with metastatic castration-resistant prostate cancer (mCRPC). Part 2: Arms 2 and 3 enrolled participants with newly diagnosed high-risk localized prostate cancer (LPC). A total of 75 participants (9 participants in Part 1 and 66 in Part 2) were enrolled in this study. All participants in Part 1 and Part 2 received the same dose of cemiplimab.
Participants by arm
| Arm | Count |
|---|---|
| Part 1 (mCRPC): BNT112 Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 100 to 1175 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression. | 9 |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 25 to 1675 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 along with cemiplimab IV Q3W for each of the 21-days treatment cycles until unacceptable toxicity or disease progression. | 28 |
| Part 2 (mCRPC): Arm 1b: BNT112 Participants with mCRPC received IV administration of BNT112 (cumulative doses ranged from 25 to 3575 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression. | 27 |
| Part 2 (LPC): Arm 2: BNT112 + Cemiplimab Participants with high-risk LPC received IV administration of BNT112 (cumulative doses ranged from 1075 to 1075 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 along with cemiplimab IV Q3W for each of the 21-days treatment cycles until unacceptable toxicity or disease progression, or up to Cycle 8 followed by radical prostatectomy. | 5 |
| Part 2 (LPC): Arm 3: BNT112 Participants with high-risk LPC received IV administration of BNT112 (cumulative doses ranged from 975 to 1075 mcg) on Days 1, 8 and 15 of Cycle 1 and Cycle 2, thereafter Q3W starting with Day 1 of Cycle 3 for each of the 21-days treatment cycles until unacceptable toxicity or disease progression, or up to Cycle 8 followed by radical prostatectomy. | 6 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Part 1: Dose Titration | Death | 6 | 0 | 0 | 0 | 0 |
| Part 1: Dose Titration | Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 |
| Part 2: Dose Expansion | Death | 0 | 17 | 13 | 1 | 0 |
| Part 2: Dose Expansion | Lost to Follow-up | 0 | 0 | 1 | 0 | 0 |
| Part 2: Dose Expansion | Other | 0 | 0 | 1 | 0 | 0 |
| Part 2: Dose Expansion | Progressive Disease | 0 | 0 | 1 | 0 | 0 |
| Part 2: Dose Expansion | Study Terminated By Sponsor | 0 | 1 | 1 | 0 | 1 |
| Part 2: Dose Expansion | Withdrawal by Subject | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Part 1 (mCRPC): BNT112 | Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Part 2 (mCRPC): Arm 1b: BNT112 | Part 2 (LPC): Arm 2: BNT112 + Cemiplimab | Part 2 (LPC): Arm 3: BNT112 |
|---|---|---|---|---|---|---|
| Age, Customized >= 50 - < 65 years | 26 Participants | 1 Participants | 7 Participants | 11 Participants | 3 Participants | 4 Participants |
| Age, Customized < 50 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized >= 65 - < 85 years | 48 Participants | 8 Participants | 20 Participants | 16 Participants | 2 Participants | 2 Participants |
| Age, Customized >= 85 years | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 0 Participants | 4 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 69 Participants | 9 Participants | 23 Participants | 27 Participants | 4 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 69 Participants | 8 Participants | 27 Participants | 26 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 75 Participants | 9 Participants | 28 Participants | 27 Participants | 5 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 7 / 9 | 17 / 28 | 13 / 27 | 1 / 5 | 0 / 6 |
| other Total, other adverse events | 8 / 9 | 28 / 28 | 26 / 27 | 5 / 5 | 6 / 6 |
| serious Total, serious adverse events | 5 / 9 | 5 / 28 | 9 / 27 | 2 / 5 | 2 / 6 |
Outcome results
Primary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Related to Trial Procedure
TEAE: any adverse event (AE) with an onset date on or after the first administration of investigational medicinal product (IMP) or worsened after first administration of IMP. AEs with an onset date more than 30 days after last dose of BNT112 or 90 days after last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) were only considered as TEAEs if assessed as related to IMP by the investigator. Serious adverse event (SAE): any untoward medical occurrence that, at any dose: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect or was another medically important condition. AEs were graded for severity using National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v5.0), where Grade 1: Mild; Grade 2: Moderate; Grade 3: Severe; Grade 4 - Life-threatening consequences; Grade 5: Death related to AE.
Time frame: From Baseline up to 30 days after the last dose of BNT112 (for Part 1 and Part 2 Arms 1b and 3) or up to 90 days after the last dose of cemiplimab (for Part 2, Arm 1a and Arm 2) (up to 4 years and 1 month)
Population: Analysis was performed on safety set that included all participants who received at least 1 dose of the IMP.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1 (mCRPC): BNT112 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Related to Trial Procedure | Grade 5 TEAEs | 2 Participants |
| Part 1 (mCRPC): BNT112 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Related to Trial Procedure | TEAEs | 8 Participants |
| Part 1 (mCRPC): BNT112 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Related to Trial Procedure | TEAEs related to trial procedure | 1 Participants |
| Part 1 (mCRPC): BNT112 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Related to Trial Procedure | Serious TEAE | 5 Participants |
| Part 1 (mCRPC): BNT112 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Related to Trial Procedure | Grade >= 3 TEAEs | 7 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Related to Trial Procedure | Grade 5 TEAEs | 0 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Related to Trial Procedure | Grade >= 3 TEAEs | 15 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Related to Trial Procedure | Serious TEAE | 5 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Related to Trial Procedure | TEAEs related to trial procedure | 1 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Related to Trial Procedure | TEAEs | 28 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Related to Trial Procedure | Grade >= 3 TEAEs | 15 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Related to Trial Procedure | TEAEs | 26 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Related to Trial Procedure | Serious TEAE | 9 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Related to Trial Procedure | Grade 5 TEAEs | 1 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Related to Trial Procedure | TEAEs related to trial procedure | 0 Participants |
| Part 2 (LPC): Arm 2: BNT112 + Cemiplimab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Related to Trial Procedure | TEAEs related to trial procedure | 1 Participants |
| Part 2 (LPC): Arm 2: BNT112 + Cemiplimab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Related to Trial Procedure | TEAEs | 5 Participants |
| Part 2 (LPC): Arm 2: BNT112 + Cemiplimab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Related to Trial Procedure | Grade 5 TEAEs | 0 Participants |
| Part 2 (LPC): Arm 2: BNT112 + Cemiplimab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Related to Trial Procedure | Grade >= 3 TEAEs | 1 Participants |
| Part 2 (LPC): Arm 2: BNT112 + Cemiplimab | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Related to Trial Procedure | Serious TEAE | 2 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Related to Trial Procedure | Grade >= 3 TEAEs | 4 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Related to Trial Procedure | Grade 5 TEAEs | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Related to Trial Procedure | TEAEs | 6 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Related to Trial Procedure | TEAEs related to trial procedure | 2 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAEs Related to Trial Procedure | Serious TEAE | 2 Participants |
Primary
Part 1: Number of Participants With Dose Limiting Toxicities (DLTs)
DLT criteria were defined as following: any treatment-emergent adverse events (TEAE) of Grade 5 intensity; hematological toxicities (Grade 3 and 4 febrile neutropenia, Grade 4 thrombocytopenia, Grade 3 and 4 hemorrhage associated with thrombocytopenia of Grade greater than or equal to \[\>=\] 3, Grade 4 anemia); and non-hematological toxicities (Grade 4 cytokine release syndrome \[CRS\], Grade 3 CRS which has not improved to Grade 1 or resolved within 48 hours; any Grade \>=3 non-hematological TEAE at least possibly related which occurs during the first BNT112 cancer vaccine treatment cycle).
Time frame: Cycle 1 (21 days)
Population: Analysis was performed on the DLT evaluation set that included all participants who received IMP and completed the DLT evaluation period and met the minimum exposure criterion or experienced a DLT during Cycle 1. Data for this outcome measure was not planned to be collected and analyzed for Part 2 arms.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part 1 (mCRPC): BNT112 | Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) | 2 Participants |
Primary
Part 2 Arm 1a: Objective Response Rate (ORR)
ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) as per Prostate Cancer Working Group 3 (PCWG3) criteria as determined by the investigator. Participants not meeting the criteria for CR or PR, including those without any post-baseline tumor assessments, were considered as non-responders. CR was defined as the disappearance of all target lesions, with a reduction in short axis to \<10 mm in any pathological lymph nodes and no new lesions. PR was defined as 30% decrease in the sum of the longest diameter of target lesions.
Time frame: From start of treatment up to 46 weeks
Population: Analysis was performed on modified Intent to Treat population (mITT) population that included all participants who were randomized to the IMP and had a baseline and at least one post-baseline (i.e., one on-treatment or post-treatment) tumor assessment (clinical or imaging assessment). Data for this outcome measure was not planned to be collected and analyzed for Part 2: Arms 2 and 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1 (mCRPC): BNT112 | Part 2 Arm 1a: Objective Response Rate (ORR) | 0 percentage of participants |
p-value: 0.1041Fisher Exact
Primary
Part 2 Arm 1b: Objective Response Rate (ORR)
ORR was defined as the percentage of participants with a CR or PR as per PCWG3 criteria as determined by the investigator. Participants not meeting the criteria for CR or PR, including those without any post-baseline tumor assessments, were considered as non-responders. CR was defined as the disappearance of all target lesions, with a reduction in short axis to \<10 mm in any pathological lymph nodes and no new lesions. PR was defined as 30% decrease in the sum of the longest diameter of target lesions.
Time frame: From start of treatment up to 104 weeks
Population: Analysis was performed on mITT population. Data for this outcome measure was not planned to be collected and analyzed for Part 2: Arms 2 and 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1 (mCRPC): BNT112 | Part 2 Arm 1b: Objective Response Rate (ORR) | 12.0 percentage of participants |
p-value: 0.0541Binomial test
Secondary
Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels
Participants blood samples were tested for levels of PSA to track the progression of prostate cancer. PSA decline categories of No decline, 0 to 25%, \>25% to 50%, and \>50% compared to baseline during treatment according to PCWG3 (as reported by the investigator) are reported in this outcome measure. EOT in the timeframe below refers to End of treatment.
Time frame: Day8 (Cycles1&2 only), Day1 Cycle 2 & Day 15 (Cycles1,2 & 8 only) (each cycle of 21-days), & EOT (30 days after last dose of BNT112 [Part 1 & Part 2 Arms 1b & 3] or 90 days after last dose of cemiplimab [Part 2, Arm 1a & Arm 2] [up to 4 years & 1 months])
Population: Analysis was performed on mITT population. Here, Overall number of participants analyzed = participants with available data for this outcome measure and number analyzed signifies participants with available data for each specified category at respective visit and 0 in the number analyzed field signifies that no participants were available for analysis at the specified visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1 (mCRPC): BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | EOT: No decline | 7 Participants |
| Part 1 (mCRPC): BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 2 Day 1: 0 to 25% | 2 Participants |
| Part 1 (mCRPC): BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 2 Day 8: No decline | 1 Participants |
| Part 1 (mCRPC): BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | EOT: 0 to 25% | 0 Participants |
| Part 1 (mCRPC): BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 2 Day 8: > 25% to 50% | 0 Participants |
| Part 1 (mCRPC): BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 2 Day 8: 0 to 25% | 0 Participants |
| Part 1 (mCRPC): BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | EOT: > 25% to 50% | 0 Participants |
| Part 1 (mCRPC): BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 2 Day 1: >50% | 0 Participants |
| Part 1 (mCRPC): BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 2 Day 1: No decline | 6 Participants |
| Part 1 (mCRPC): BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 2 Day 8: >50% | 0 Participants |
| Part 1 (mCRPC): BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | EOT: >50% | 0 Participants |
| Part 1 (mCRPC): BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 2 Day 1: Greater than (>) 25% to 50% | 0 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | EOT: >50% | 0 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | EOT: > 25% to 50% | 0 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 2 Day 1: No decline | 21 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | EOT: 0 to 25% | 2 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 2 Day 1: 0 to 25% | 3 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 2 Day 1: Greater than (>) 25% to 50% | 0 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 2 Day 1: >50% | 0 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | EOT: No decline | 17 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 2 Day 1: Greater than (>) 25% to 50% | 1 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 2 Day 1: No decline | 19 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | EOT: No decline | 19 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | EOT: 0 to 25% | 0 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 8 Day 15: > 25% to 50% | 0 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 2 Day 1: >50% | 1 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | EOT: > 25% to 50% | 0 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 8 Day 15: >50% | 0 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 8 Day 15: No decline | 1 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 2 Day 1: 0 to 25% | 2 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | EOT: >50% | 0 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 8 Day 15: 0 to 25% | 0 Participants |
| Part 2 (LPC): Arm 2: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | EOT: No decline | 0 Participants |
| Part 2 (LPC): Arm 2: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 2 Day 1: No decline | 1 Participants |
| Part 2 (LPC): Arm 2: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 2 Day 1: 0 to 25% | 1 Participants |
| Part 2 (LPC): Arm 2: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 2 Day 1: Greater than (>) 25% to 50% | 0 Participants |
| Part 2 (LPC): Arm 2: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 2 Day 1: >50% | 3 Participants |
| Part 2 (LPC): Arm 2: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | EOT: 0 to 25% | 0 Participants |
| Part 2 (LPC): Arm 2: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | EOT: > 25% to 50% | 0 Participants |
| Part 2 (LPC): Arm 2: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | EOT: >50% | 4 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 2 Day 15: No decline | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 2 Day 8: >50% | 1 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 2 Day 8: > 25% to 50% | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 2 Day 8: 0 to 25% | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 2 Day 8: No decline | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 2 Day 1: >50% | 4 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 2 Day 1: Greater than (>) 25% to 50% | 1 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 1 Day 8: No decline | 1 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | EOT: No decline | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 2 Day 1: 0 to 25% | 1 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 2 Day 1: No decline | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 1 Day 15: >50% | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 1 Day 8: 0 to 25% | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | EOT: 0 to 25% | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 1 Day 15: >25% to 50% | 1 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 1 Day 15: 0 to 25% | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 1 Day 15: No decline | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | EOT: >50% | 3 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | EOT: > 25% to 50% | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 1 Day 8: >50% | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 1 Day 8: Greater than (>) 25% to 50% | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 2 Day 15: 0 to 25% | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 2 Day 15: > 25% to 50% | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in Prostate-specific Antigen (PSA) Levels | Cycle 2 Day 15: >50% | 1 Participants |
Secondary
Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT)
Participants blood samples were tested for levels of PSA to track the progression of prostate cancer. PSADT was calculated using a linear regression model of the natural logarithm of PSA values and time. PSA doubling time compared to baseline during the treatment period for the following categories: 0 - 3 months; \>3 - 6 months; \>6 - 9 months; \>9 - 12 months; \>12 - 18 months; \>18 - 24 months; \>24 months and declining are reported in this outcome measure.
Time frame: Cycle 4 Day 1, Cycle 8 Day 1, Cycle 12 Day 1 (each cycle duration=21 days)
Population: Analysis was performed on mITT population. Here, Overall number of participants analyzed = participants with available data for this outcome measure and number analyzed signifies participants with available data for each specified category.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1 (mCRPC): BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1: >24 months | 0 Participants |
| Part 1 (mCRPC): BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1: >3 - 6 months | 0 Participants |
| Part 1 (mCRPC): BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1: >6 - 9 months | 1 Participants |
| Part 1 (mCRPC): BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1: >9 - 12 months | 0 Participants |
| Part 1 (mCRPC): BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1: >12 - 18 months | 0 Participants |
| Part 1 (mCRPC): BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1: >18 - 24 months | 0 Participants |
| Part 1 (mCRPC): BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1: 0 - 3 months | 5 Participants |
| Part 1 (mCRPC): BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1: Declining | 0 Participants |
| Part 1 (mCRPC): BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 8 Day 1: 0 - 3 months | 3 Participants |
| Part 1 (mCRPC): BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 8 Day 1: >3 - 6 months | 0 Participants |
| Part 1 (mCRPC): BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 8 Day 1: >6 - 9 months | 0 Participants |
| Part 1 (mCRPC): BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 8 Day 1: >9 - 12 months | 0 Participants |
| Part 1 (mCRPC): BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 8 Day 1: >12 - 18 months | 0 Participants |
| Part 1 (mCRPC): BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 8 Day 1: >18 - 24 months | 0 Participants |
| Part 1 (mCRPC): BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 8 Day 1: > 24 months | 1 Participants |
| Part 1 (mCRPC): BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 8 Day 1: Declining | 0 Participants |
| Part 1 (mCRPC): BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 12 Day 1: 0 - 3 months | 3 Participants |
| Part 1 (mCRPC): BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 12 Day 1: >3 - 6 months | 0 Participants |
| Part 1 (mCRPC): BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 12 Day 1: >6 - 9 months | 0 Participants |
| Part 1 (mCRPC): BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 12 Day 1: >9 - 12 months | 0 Participants |
| Part 1 (mCRPC): BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 12 Day 1: >12 - 18 months | 0 Participants |
| Part 1 (mCRPC): BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 12 Day 1: >18 - 24 months | 0 Participants |
| Part 1 (mCRPC): BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 12 Day 1: > 24 months | 0 Participants |
| Part 1 (mCRPC): BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 12 Day 1: Declining | 0 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1: 0 - 3 months | 16 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 12 Day 1: >12 - 18 months | 0 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 12 Day 1: >18 - 24 months | 0 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 8 Day 1: >6 - 9 months | 1 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 12 Day 1: >3 - 6 months | 3 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1: >24 months | 0 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1: >6 - 9 months | 1 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 12 Day 1: >9 - 12 months | 0 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 8 Day 1: >9 - 12 months | 0 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 8 Day 1: 0 - 3 months | 6 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 12 Day 1: >6 - 9 months | 1 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 12 Day 1: > 24 months | 0 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1: >18 - 24 months | 0 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 8 Day 1: >12 - 18 months | 0 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 12 Day 1: 0 - 3 months | 2 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1: >12 - 18 months | 0 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1: >3 - 6 months | 2 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1: >9 - 12 months | 0 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 8 Day 1: >18 - 24 months | 0 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 8 Day 1: Declining | 1 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 8 Day 1: >3 - 6 months | 5 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 12 Day 1: Declining | 1 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1: Declining | 2 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 8 Day 1: > 24 months | 0 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 12 Day 1: >9 - 12 months | 1 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1: Declining | 3 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 8 Day 1: Declining | 2 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 12 Day 1: > 24 months | 0 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 12 Day 1: 0 - 3 months | 0 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 12 Day 1: >6 - 9 months | 2 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1: >9 - 12 months | 0 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 12 Day 1: >3 - 6 months | 1 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 8 Day 1: 0 - 3 months | 8 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1: >12 - 18 months | 0 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 12 Day 1: Declining | 2 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 8 Day 1: >3 - 6 months | 1 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 12 Day 1: >12 - 18 months | 0 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1: >6 - 9 months | 2 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 8 Day 1: >6 - 9 months | 0 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 12 Day 1: >18 - 24 months | 0 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 8 Day 1: >9 - 12 months | 2 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1: >24 months | 0 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1: >3 - 6 months | 2 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 8 Day 1: >12 - 18 months | 1 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 8 Day 1: > 24 months | 1 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 8 Day 1: >18 - 24 months | 0 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1: >18 - 24 months | 1 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1: 0 - 3 months | 11 Participants |
| Part 2 (LPC): Arm 2: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1: >12 - 18 months | 0 Participants |
| Part 2 (LPC): Arm 2: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1: >18 - 24 months | 0 Participants |
| Part 2 (LPC): Arm 2: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1: >24 months | 0 Participants |
| Part 2 (LPC): Arm 2: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 12 Day 1: >12 - 18 months | 0 Participants |
| Part 2 (LPC): Arm 2: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1: Declining | 4 Participants |
| Part 2 (LPC): Arm 2: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 8 Day 1: 0 - 3 months | 0 Participants |
| Part 2 (LPC): Arm 2: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 8 Day 1: >3 - 6 months | 0 Participants |
| Part 2 (LPC): Arm 2: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 8 Day 1: >6 - 9 months | 0 Participants |
| Part 2 (LPC): Arm 2: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 8 Day 1: >9 - 12 months | 0 Participants |
| Part 2 (LPC): Arm 2: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 12 Day 1: >18 - 24 months | 0 Participants |
| Part 2 (LPC): Arm 2: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 8 Day 1: >12 - 18 months | 0 Participants |
| Part 2 (LPC): Arm 2: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 8 Day 1: >18 - 24 months | 0 Participants |
| Part 2 (LPC): Arm 2: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 12 Day 1: Declining | 4 Participants |
| Part 2 (LPC): Arm 2: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 8 Day 1: > 24 months | 0 Participants |
| Part 2 (LPC): Arm 2: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 8 Day 1: Declining | 5 Participants |
| Part 2 (LPC): Arm 2: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 12 Day 1: 0 - 3 months | 0 Participants |
| Part 2 (LPC): Arm 2: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 12 Day 1: > 24 months | 0 Participants |
| Part 2 (LPC): Arm 2: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 12 Day 1: >3 - 6 months | 0 Participants |
| Part 2 (LPC): Arm 2: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 12 Day 1: >6 - 9 months | 0 Participants |
| Part 2 (LPC): Arm 2: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1: 0 - 3 months | 1 Participants |
| Part 2 (LPC): Arm 2: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1: >3 - 6 months | 0 Participants |
| Part 2 (LPC): Arm 2: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 12 Day 1: >9 - 12 months | 0 Participants |
| Part 2 (LPC): Arm 2: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1: >6 - 9 months | 0 Participants |
| Part 2 (LPC): Arm 2: BNT112 + Cemiplimab | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1: >9 - 12 months | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 8 Day 1: Declining | 6 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 8 Day 1: > 24 months | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 8 Day 1: >18 - 24 months | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1: >9 - 12 months | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1: 0 - 3 months | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 12 Day 1: >18 - 24 months | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 8 Day 1: >12 - 18 months | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 8 Day 1: >9 - 12 months | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1: Declining | 5 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1: >3 - 6 months | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1: >24 months | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 8 Day 1: >6 - 9 months | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 8 Day 1: >3 - 6 months | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1: >18 - 24 months | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1: >6 - 9 months | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 12 Day 1: >9 - 12 months | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 8 Day 1: 0 - 3 months | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 12 Day 1: >12 - 18 months | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 12 Day 1: > 24 months | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 12 Day 1: >3 - 6 months | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 12 Day 1: 0 - 3 months | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 4 Day 1: >12 - 18 months | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 12 Day 1: >6 - 9 months | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants Reporting Change From Baseline in PSA Doubling Time (PSADT) | Cycle 12 Day 1: Declining | 3 Participants |
Secondary
Number of Participants With PSA Decline of >=50%
Participants blood samples were tested for levels of PSA to track the progression of prostate cancer. Participants with PSA decline of \>=50% compared to baseline according to PCWG3 (as reported by the investigator) are reported in this outcome measure. EOT in the timeframe below refers to End of treatment.
Time frame: Day8 (Cycles1&2 only), Day1 Cycle 2 & Day 15 (Cycles1,2 & 8 only) (each cycle of 21-days), & EOT (30 days after last dose of BNT112 [Part 1 & Part 2 Arms 1b & 3] or 90 days after last dose of cemiplimab [Part 2, Arm 1a & Arm 2] [up to 4 years & 1 months])
Population: Analysis was performed on mITT population. Here, Overall number of participants analyzed = participants with available data for this outcome measure and number analyzed signifies participants with available data for each specified category at respective visit and 0 in the number analyzed field signifies that no participants were available for analysis at the specified visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1 (mCRPC): BNT112 | Number of Participants With PSA Decline of >=50% | Cycle 2 Day 8 | 0 Participants |
| Part 1 (mCRPC): BNT112 | Number of Participants With PSA Decline of >=50% | Cycle 2 Day 1 | 0 Participants |
| Part 1 (mCRPC): BNT112 | Number of Participants With PSA Decline of >=50% | EOT | 0 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Number of Participants With PSA Decline of >=50% | Cycle 2 Day 1 | 0 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Number of Participants With PSA Decline of >=50% | EOT | 0 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants With PSA Decline of >=50% | EOT | 0 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants With PSA Decline of >=50% | Cycle 2 Day 1 | 1 Participants |
| Part 2 (mCRPC): Arm 1b: BNT112 | Number of Participants With PSA Decline of >=50% | Cycle 8 Day 15 | 0 Participants |
| Part 2 (LPC): Arm 2: BNT112 + Cemiplimab | Number of Participants With PSA Decline of >=50% | EOT | 4 Participants |
| Part 2 (LPC): Arm 2: BNT112 + Cemiplimab | Number of Participants With PSA Decline of >=50% | Cycle 2 Day 1 | 3 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants With PSA Decline of >=50% | Cycle 2 Day 15 | 1 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants With PSA Decline of >=50% | Cycle 2 Day 8 | 1 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants With PSA Decline of >=50% | Cycle 2 Day 1 | 4 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants With PSA Decline of >=50% | Cycle 1 Day 15 | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants With PSA Decline of >=50% | Cycle 1 Day 8 | 0 Participants |
| Part 2 (LPC): Arm 3: BNT112 | Number of Participants With PSA Decline of >=50% | EOT | 3 Participants |
Secondary
Part 1: Objective Response Rate (ORR)
ORR was defined as the percentage of participants with a CR or PR as per PCWG3 criteria as determined by the investigator. Participants not meeting the criteria for CR or PR, including those without any post-baseline tumor assessments, were considered as non-responders. CR was defined as the disappearance of all target lesions, with a reduction in short axis to \<10 mm in any pathological lymph nodes and no new lesions. PR was defined as 30% decrease in the sum of the longest diameter of target lesions.
Time frame: From start of treatment up to 27 weeks
Population: Analysis was performed on mITT population. Data for this outcome measure was not planned to be collected and analyzed for Part 2: Arms 2 and 3.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part 1 (mCRPC): BNT112 | Part 1: Objective Response Rate (ORR) | 0 percentage of participants |
Secondary
Part 2: Arms 2 and 3: Number of Participants With Tumor Response Post-Treatment
The best overall response was defined as a single best response status at any tumor response assessment after first administration of IMP and prior to or at the start date of the first subsequent anti-cancer therapy. Overall response of progressive disease within 14 days after the start date of first subsequent anti-cancer therapy was considered. The following order of tumor response categories were used, where Complete Response is the best category: Complete Response (CR) - Partial Response (PR) - Stable Disease (SD) - Progressive Disease (PD) - Not Evaluable (NE) - Missing. CR: disappearance of all target lesions, with reduction in short axis to \<10 mm in any pathological lymph nodes and no new lesions. PR:30% decrease in the sum of the longest diameter of target lesions. PD: progression of target lesions (sum of diameter increase to nadir of \>=20% and by \>=5 mm), progression of existing non-target lesions, or appearance of 1 or more new lesions.SD: no evidence of PD, CR or PR.
Time frame: From start of treatment up to 25 weeks (Arm 2) and up to 26 weeks (Arm 3)
Population: Analysis was performed on mITT population. Data for this outcome measure was not planned to be collected and analyzed for Part 1 and Part 2: Arms 1a and 1b.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1 (mCRPC): BNT112 | Part 2: Arms 2 and 3: Number of Participants With Tumor Response Post-Treatment | Complete Response (CR) | 0 Participants |
| Part 1 (mCRPC): BNT112 | Part 2: Arms 2 and 3: Number of Participants With Tumor Response Post-Treatment | Partial Response (PR) | 3 Participants |
| Part 1 (mCRPC): BNT112 | Part 2: Arms 2 and 3: Number of Participants With Tumor Response Post-Treatment | Stable Disease (SD) | 2 Participants |
| Part 1 (mCRPC): BNT112 | Part 2: Arms 2 and 3: Number of Participants With Tumor Response Post-Treatment | Progressive Disease (PD) | 0 Participants |
| Part 1 (mCRPC): BNT112 | Part 2: Arms 2 and 3: Number of Participants With Tumor Response Post-Treatment | Not Evaluable (NE) | 0 Participants |
| Part 1 (mCRPC): BNT112 | Part 2: Arms 2 and 3: Number of Participants With Tumor Response Post-Treatment | Missing | 0 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Part 2: Arms 2 and 3: Number of Participants With Tumor Response Post-Treatment | Not Evaluable (NE) | 0 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Part 2: Arms 2 and 3: Number of Participants With Tumor Response Post-Treatment | Complete Response (CR) | 0 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Part 2: Arms 2 and 3: Number of Participants With Tumor Response Post-Treatment | Progressive Disease (PD) | 0 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Part 2: Arms 2 and 3: Number of Participants With Tumor Response Post-Treatment | Partial Response (PR) | 3 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Part 2: Arms 2 and 3: Number of Participants With Tumor Response Post-Treatment | Missing | 1 Participants |
| Part 2 (mCRPC): Arm 1a: BNT112 + Cemiplimab | Part 2: Arms 2 and 3: Number of Participants With Tumor Response Post-Treatment | Stable Disease (SD) | 2 Participants |