Study to Evaluate the Efficacy and Tolerability of Debio 1562 in Combination With Rituximab in Participants With Relapsed and/or Refractory DLBCL and Other Forms of NHL

The clinical laboratory tests included Hematology: Hematocrit (Hct), hemoglobin (Hgb), platelet count, red blood cell (RBC) count, white blood cell (WBC) count with differential; Serum Chemistry: Albumin (ALB), alkaline phosphatase (ALK-P), alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN), calcium (Ca), chloride (Cl), creatinine, glucose, lactate dehydrogenase (LDH), magnesium, phosphorus, potassium (K), sodium (Na), total bilirubin, total protein, uric acid, immunoglobulin levels (IgG, IgA, IgM); Urinalysis: Appearance, specific gravity and pH, evaluation of glucose, protein, bilirubin, ketones, leukocytes and blood; Coagulation: Prothrombin time (PT) or international normalized ratio (INR), activated partial thromboplastin time (aPTT).

Time frame: Up to 30 days after EOT (Up to 38 months)

Population: Safety population includes all participants from the screened population who received at least one dose of Debio 1562.

A standard 12-lead ECG was performed.

Time frame: Up to 30 days after EOT (Up to 38 months)

Population: Safety population included all participants from the screened population who received at least one dose of Debio 1562.

Vital signs included systolic and diastolic blood pressure, heart rate, temperature, and respiratory rate.

Time frame: Up to 30 days after EOT (Up to 38 months)

Population: Safety population included all participants from the screened population who received at least one dose of Debio 1562.

An AE was defined as any noxious, pathologic, or unintended change in anatomical, physiologic, or metabolic function as indicated by physical signs, symptoms, or laboratory changes occurring in any phase of a clinical study, whether or not considered study drug related. This included exacerbation of a pre-existing condition. AEs included worsening (change in nature, severity, or frequency) of conditions present at the onset of the study, intercurrent illnesses, drug interactions, events related to or possibly related to concomitant medications, abnormal laboratory values (this included significant shifts from baseline within the range of normal that the Investigator considered to be clinically important), clinically significant abnormalities in physical examination, vital signs, and weight.

Time frame: Up to 30 days after end of treatment (EOT) (Up to 38 months)

Population: Safety population included all participants from the screened population who received at least one dose of Debio 1562.

ORR was defined as the percentage of participants with a Best overall response (BOR) of partial response (PR) or complete response (CR). BOR was the best response recorded from the start of the treatment until disease progression, initiation of new anti-cancer therapy, or end of the study period, whichever occurred first. CR was defined as disappearance of all target lesions, no new lesions formation. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to ≤1.5 cm. PR was defined as ≥50% decrease in the sum of diameters of up to 6 target measurable nodes or extranodal sites, no new lesions formation.

Time frame: Up to Progressive Disease (PD) or death (up to approximately 55 months) or initiation of new anti-cancer therapy whichever occurs first

Population: EE population included all participants who received at least one dose of Debio 1562 and rituximab and had both baseline and post-baseline evaluable disease assessments (including clinical PD).

Time frame: Parts 1, 2/3: Pre-dose, post infusion-5 min on Day 1 of C 1-6, 5 min on Day 1 of C 7, 8 and 2 h on Day 1 of C 1, 2 (only for Part 2/3), 24 h on Day 2, 48 h on Day 3, Days 8 and 15 of C 1, 2 (Cycle=21 days); EOT (up to 37 months), 30-day follow up

Population: Debio 1562 PK analysis was performed by population PK approach, this data was not collected. This data was also not collected for Rituximab.

Time frame: Parts 1, 2/3: Pre-dose, post infusion-5 min on Day 1 of C 1-6, 5 min on Day 1 of C 7, 8 and 2 h on Day 1 of C 1, 2 (only for Part 2/3), 24 h on Day 2, 48 h on Day 3, Days 8 and 15 of C 1, 2 (Cycle=21 days); EOT (up to 37 months), 30-day follow up

Population: Debio 1562 PK analysis was performed by population PK approach, this data was not collected. This data was also not collected for Rituximab.

Time frame: Parts 1, 2/3: Pre-dose, post infusion-5 min on Day 1 of C 1-6, 5 min on Day 1 of C 7, 8 and 2 h on Day 1 of C 1, 2 (only for Part 2/3), 24 h on Day 2, 48 h on Day 3, Days 8 and 15 of C 1, 2 (Cycle=21 days); EOT (up to 37 months), 30-day follow up

Population: Debio 1562 PK analysis was performed by population PK approach, this data was not collected. This data was also not collected for Rituximab.

DOR was defined as duration between date of the first objective response (PR or CR) and date of PD or death due to any cause, whichever occurs first. CR: Disappearance of all target lesions, no new lesions formation, any pathological lymph nodes (whether target or non-target) must have reduction in short axis to ≤1.5 cm. PR: ≥50% decrease in sum of diameters of up to 6 target measurable nodes or extranodal sites, no new lesions formation. PD: New or clear progression of preexisting non-measured lesions or regrowth of previously resolved lesions or a new node \>1.5 cm in any axis or an abnormal lesion with \>1.5 cm longest transverse diameter or increase by \>50% of lesion.

Time frame: Up to PD or death or end of study (approximately 57 months) or initiation of new anti-cancer therapy whichever occurs first

Population: EE population included all participants who received at least one dose of Debio 1562 and rituximab and had both baseline and post-baseline evaluable disease assessments (including clinical PD). Overall number of participants analyzed signifies the number of participants who responded.

Time frame: Parts 1, 2/3: Pre and Post infusion: 5 min-Day (D) 1 of Cycles (C) 1-8 and 2 hours (h)-D1 of C1-2 (for Part 2/3), 24h-D2, 48h-D3 and D8, 15 of C1, 2; D1 of Month 37 (EOT) (rituximab only) and Month 38 (follow-up) (Cycle=21 days)

Population: PK population included all participants who received at least one dose of Debio 1562 or rituximab and had atleast one PK concentration result available. Number analyzed signifies the number of participants with available data at the specific timepoint.

The potential immunogenicity against Debio 1562 was assessed in an ADA population.

Time frame: Part 1: Pre-dose on Day 1 of Cycle(C)1 to 8; Part 2/3: Pre-dose on Day 1 of C1 to 6 and on Day 1 of C7 for participants who received treatment beyond C6 (each C=21 days); Parts 1, 2/3: Month 37 (EOT) and Month 38 (30-Day FU visit) (Cycle=21 days)

Population: ADA population included all participants who received at least one dose of Debio 1562 or rituximab and had at least one ADA post exposure result available. Overall number of participants analyzed signifies number of participants with non-missing ADA value at baseline and at least one non-missing post-treatment value.

OS was defined as the duration between the first dose date of Debio 1562 and the date of death due to any cause.

Time frame: Up to death or end of study (approximately 57 months) or one year from the last participant's first dose

Population: EE population included all participants who received at least one dose of Debio 1562 and rituximab and had both baseline and post-baseline evaluable disease assessments (including clinical PD).

PFS was defined as the duration between the first dose date of Debio 1562 and the date of progressive disease (PD) or death due to any cause, whichever occurs first. PD is defined as the new or clear progression of preexisting non-measured lesions or regrowth of previously resolved lesions or a new node \>1.5 cm in any axis or an abnormal lesion with \>1.5 cm longest transverse diameter or increase by \>50% of lesion.

Time frame: Up to PD or death or end of study (approximately 57 months) or initiation of new anti-cancer therapy whichever occurs first

Population: EE population included all participants who received at least one dose of Debio 1562 and rituximab and had both baseline and post-baseline evaluable disease assessments (including clinical PD).

Time frame: Parts 1, 2/3: Pre-dose, post infusion-5 min on Day 1 of C 1-6, 5 min on Day 1 of C 7, 8 and 2 h on Day 1 of C 1, 2 (only for Part 2/3), 24 h on Day 2, 48 h on Day 3, Days 8 and 15 of C 1, 2 (Cycle=21 days); EOT (up to 37 months), 30-day follow up

Population: Debio 1562 PK analysis was performed by population PK approach, this data was not collected. This data was also not collected for Rituximab.

Time frame: Parts 1, 2/3: Pre-dose, post infusion-5 min on Day 1 of C 1-6, 5 min on Day 1 of C 7, 8 and 2 h on Day 1 of C 1, 2 (only for Part 2/3), 24 h on Day 2, 48 h on Day 3, Days 8 and 15 of C 1, 2 (Cycle=21 days); EOT (up to 37 months), 30-day follow up

Population: Debio 1562 PK analysis was performed by population PK approach, this data was not collected. This data was also not collected for Rituximab.

TTR was defined as the duration between the first dose date of Debio 1562 and the date of first objective response (PR or CR). CR was defined as disappearance of all target lesions, no new lesions formation. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to ≤ 1.5 cm. PR was defined as ≥50% decrease in the sum of diameters of up to 6 target measurable nodes or extranodal sites, no new lesions formation.

Time frame: Up to PD or death or end of study (approximately 57 months) or initiation of new anti-cancer therapy whichever occurs first

Population: EE population included all participants who received at least one dose of Debio 1562 and rituximab and had both baseline and post-baseline evaluable disease assessments (including clinical PD). Overall number of participants analyzed signifies the number of participants who responded.

Time frame: Parts 1, 2/3: Pre-dose, post infusion-5 min on Day 1 of C 1-6, 5 min on Day 1 of C 7, 8 and 2 h on Day 1 of C 1, 2 (only for Part 2/3), 24 h on Day 2, 48 h on Day 3, Days 8 and 15 of C 1, 2 (Cycle=21 days); EOT (up to 37 months), 30-day follow up

Population: Debio 1562 PK analysis was performed by population PK approach, this data was not collected. This data was also not collected for Rituximab.