Histologically or cytologically confirmed MM, a European Cooperative Oncology Group performance status of 0 or 1, prior therapy with alkylators, PI and IMiD, had undergone stem cell transplant (if eligible) and refractory to the last line of treatment (defined as progressive disease on or within 60 days of completion of the last therapy) that included stem cell transplant and those patients with a history of autologous stem cell transplant must have received the transplant >100 days prior to study enrolment and have no active infection.

PK profile (single dose area under the curve, maximum serum concentration [Cmax], time to Cmax , clearance, steady-state volume of distribution [Vss], half-life [t]; repeat dose Cmax and trough plasma concentration), the incidence of anti-drug antibodies, and clinical activity measured as overall response rate (ORR), defined as the percentage of subjects achieving confirmed partial response or better (PR) and clinical benefit rate, defined as the percentages of subjects with minimal response or better (MR).

A phase 3, randomized, double-arm, open-label, controlled trial of ASP-1929 photoimmunotherapy versus physician's choice standard of care for the treatment of locoregional, recurrent head and neck squamous cell carcinoma in patients who have failed or progressed on or after at least two lines of therapy, of which at least one line must be systemic therapy.

Disease Control Rate (DCR)=13.40% (95% CI,6.3-24.0) for AGS16C3F, Disease Control Rate (DCR)=22.70% (95% CI,13.30-34.70) for axitinib. Median duration of Response (mDoR)=6.80 months (95% CI,3.80-18.40) for AGS16C3F, Median duration of Response (mDoR)=6.7 months (95% CI,1.80-9.20) for axitinib. Objective Response Rate (ORR)=7.50% (95% CI,2.50-16.60) for AGS16C3F, Objective Response Rate (ORR)=18.20% (95% CI,9.80-29.60) for axitinib. Median Overall Survival (mOS)=13.10 months for AGS16C3F, Median Overall Survival (mOS)=15.40 months for axitinib.

Exclusion criteria comprise uncontrolled CNS metastases, investigational drug use within 4 weeks prior, AGS-16C3F hypersensitivity, thromboembolic events (≤3 months), severe cardiac conditions (e.g., CHF Class III/IV), major surgery within 4 weeks, pregnancy/lactation, HIV/hepatitis B/C positivity, active infections requiring systemic treatment, or recent eye surgery/cataracts affecting vision.

Eligible participants include metastatic RCC patients (clear cell/non-clear cell or papillary histology) with prior anti-VEGFR therapy (clear cell) or ENPP3+ status (non-clear cell/papillary). Key requirements: measurable disease (RECIST 1.1), ECOG 0-1, adequate hematologic (ANC ≥1.5x10⁹/L, platelet ≥100x10⁹/L, Hb ≥9 g/dL), renal (creatinine ≤1.5xULN or GFR >50 mL/min), and hepatic function (AST/ALT ≤2.5xULN or ≤5xULN with metastases; bilirubin ≤1.5xULN). Contraception is mandated for participants of childbearing potential.

Exclusion criteria comprised prior axitinib/AGS-16C3F treatment, untreated or unstable brain metastases (>3 months post-radiation/surgery if treated), uncontrolled hypertension (>150/90), GI disorders affecting absorption, active ocular conditions (e.g., infections, corneal ulcers, glaucoma), strong CYP3A4/5 inhibitors/inducers use within 14 days, thromboembolic events (≤4 weeks unless anticoagulated), bleeding disorders (≤2 months), severe cardiac disease (NYHA Class III/IV, MI ≤6 months), major surgery ≤4 weeks, pregnancy/lactation, unresolved infections, or inability to comply with study protocols.

The study assessed Progression-Free Survival (PFS) per RECIST v1.1 by investigator (up to 53 months) and central radiology review (up to 40 months), along with Objective Response Rate (ORR), Duration of Response (DOR), Overall Survival (OS), and Disease Control Rate (DCR). Pharmacokinetic parameters (Cmax, Ctrough, Tmax, AUC₀- ₂₁, t₁/ ₂) for ADC, TAb, and Cys-mcMMAF were evaluated over 21-day cycles. Adverse events (AEs) were monitored for 53 months, with serious AEs requiring intervention or hospitalization.

Exclusion criteria comprise uncontrolled CNS metastases, investigational drug use within 4 weeks prior, AGS-16C3F hypersensitivity, thromboembolic events (≤3 months), severe cardiac conditions (e.g., CHF Class III/IV), major surgery within 4 weeks, pregnancy/lactation, HIV/hepatitis B/C positivity, active infections requiring systemic treatment, or recent eye surgery/cataracts affecting vision.

Eligible participants include metastatic RCC patients (clear cell/non-clear cell or papillary histology) with prior anti-VEGFR therapy (clear cell) or ENPP3+ status (non-clear cell/papillary). Key requirements: measurable disease (RECIST 1.1), ECOG 0-1, adequate hematologic (ANC ≥1.5x10⁹/L, platelet ≥100x10⁹/L, Hb ≥9 g/dL), renal (creatinine ≤1.5xULN or GFR >50 mL/min), and hepatic function (AST/ALT ≤2.5xULN or ≤5xULN with metastases; bilirubin ≤1.5xULN). Contraception is mandated for participants of childbearing potential.

Exclusion criteria comprised prior axitinib/AGS-16C3F treatment, untreated or unstable brain metastases (>3 months post-radiation/surgery if treated), uncontrolled hypertension (>150/90), GI disorders affecting absorption, active ocular conditions (e.g., infections, corneal ulcers, glaucoma), strong CYP3A4/5 inhibitors/inducers use within 14 days, thromboembolic events (≤4 weeks unless anticoagulated), bleeding disorders (≤2 months), severe cardiac disease (NYHA Class III/IV, MI ≤6 months), major surgery ≤4 weeks, pregnancy/lactation, unresolved infections, or inability to comply with study protocols.

The study assessed Progression-Free Survival (PFS) per RECIST v1.1 by investigator (up to 53 months) and central radiology review (up to 40 months), along with Objective Response Rate (ORR), Duration of Response (DOR), Overall Survival (OS), and Disease Control Rate (DCR). Pharmacokinetic parameters (Cmax, Ctrough, Tmax, AUC₀- ₂₁, t₁/ ₂) for ADC, TAb, and Cys-mcMMAF were evaluated over 21-day cycles. Adverse events (AEs) were monitored for 53 months, with serious AEs requiring intervention or hospitalization.

Exclusion criteria comprised prior axitinib/AGS-16C3F treatment, untreated or unstable brain metastases (>3 months post-radiation/surgery if treated), uncontrolled hypertension (>150/90), GI disorders affecting absorption, active ocular conditions (e.g., infections, corneal ulcers, glaucoma), strong CYP3A4/5 inhibitors/inducers use within 14 days, thromboembolic events (≤4 weeks unless anticoagulated), bleeding disorders (≤2 months), severe cardiac disease (NYHA Class III/IV, MI ≤6 months), major surgery ≤4 weeks, pregnancy/lactation, unresolved infections, or inability to comply with study protocols.

The study assessed Progression-Free Survival (PFS) per RECIST v1.1 by investigator (up to 53 months) and central radiology review (up to 40 months), along with Objective Response Rate (ORR), Duration of Response (DOR), Overall Survival (OS), and Disease Control Rate (DCR). Pharmacokinetic parameters (Cmax, Ctrough, Tmax, AUC₀- ₂₁, t₁/ ₂) for ADC, TAb, and Cys-mcMMAF were evaluated over 21-day cycles. Adverse events (AEs) were monitored for 53 months, with serious AEs requiring intervention or hospitalization.

For all patients in the 2L Depatux-M + CT arm, the 6-month PFS estimate by central review was 25.6% (95% CI 11.4-42.6) with a median PFS of 2.1 months (95% CI 1.9-3.9; Figure 3 A, B). The 6-month OS estimate was 89.7% (95% CI 71.3-96.5), and the median OS was 14.7 months (95% CI 10.7-15.4; Figure 4). ORR, analyzed in patients with at least one measurable disease at baseline, was 21.7% (5/23) by central review with all responses being PR and the median DoR was 5.5 months (95% CI 1.9-NE; Table 6). Seven patients were considered to have 6-month PFS by investigator review, but not by central review.

For all patients in the 2L Depatux-M + CT arm, the 6-month PFS estimate by central review was 25.6% (95% CI 11.4-42.6) with a median PFS of 2.1 months (95% CI 1.9-3.9; Figure 3 A, B). The 6-month OS estimate was 89.7% (95% CI 71.3-96.5), and the median OS was 14.7 months (95% CI 10.7-15.4; Figure 4). ORR, analyzed in patients with at least one measurable disease at baseline, was 21.7% (5/23) by central review with all responses being PR and the median DoR was 5.5 months (95% CI 1.9-NE; Table 6). Seven patients were considered to have 6-month PFS by investigator review, but not by central review.

For all patients in the 2L Depatux-M + CT arm, the 6-month PFS estimate by central review was 25.6% (95% CI 11.4-42.6) with a median PFS of 2.1 months (95% CI 1.9-3.9; Figure 3 A, B). The 6-month OS estimate was 89.7% (95% CI 71.3-96.5), and the median OS was 14.7 months (95% CI 10.7-15.4; Figure 4). ORR, analyzed in patients with at least one measurable disease at baseline, was 21.7% (5/23) by central review with all responses being PR and the median DoR was 5.5 months (95% CI 1.9-NE; Table 6). Seven patients were considered to have 6-month PFS by investigator review, but not by central review.

intravenous administration (1.25 mg/kg or 1.0 mg/kg body weight) over 30 to 40 minutes once every 2 weeks until one of the treatment withdrawal criteria was met. The dose was 1.25 mg/kg in the original protocol (Version 1) and Version 2, Amendment 1, and was lowered to 1.0 mg/kg in protocol Version 3, Amendment 2. Pediatric participants: Intravenous administration (1.0 mg/kg body weight for those who were 6 to 17 years old at the date of first dose, or 1.3 mg/kg for those who were 0 to 5 years old) over 30 to 40 minutes or as directed by the guidelines once every 2 weeks until one of the treatment withdrawal criteria was met, for a maximum of one year. If used in combination with temozolomide, depatuxizumab mafodotin was dosed on Day 1 and Day 15 of the TMZ cycle (assuming a standard regimen of 200 mg/m^2/day for 5 days of each 28-day cycle; for other TMZ schedules, timing of the depatuxizumab mafodotin dosing schedule were to be discussed with the medical monitor).

During the Chemoradiation Phase, participants were to receive depatuxizumab mafodotin at 2.0 mg/kg IV infusion over 30 - 40 minutes once every 2 weeks (Day 1 of Weeks 1, 3, and 5 of the 6-week regimen). During the Adjuvant Therapy Phase, participants were to receive depatuxizumab mafodotin at 1.25 mg/kg on Day 1 (± 2 days) and Day 15 (± 2 days) of each 28-day cycle as a 30 - 40 minute infusion for 12 cycles.

This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to ABT-414 prior to approval by the local regulatory agency. Availability will depend on territory eligibility. Participating sites will be added as they apply for and are approved for the EAP. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

Malignant solid tumor thought to be associated with increased expression of EphA2 (endometrial, breast, ovarian, prostate, non-small cell lung, colon, esophageal, gastric, and bladder cancers, renal cell carcinoma, melanoma), relapsed or refractory to standard therapy, and an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.

Eligible patients must have relapsed/refractory solid tumors (ovarian, prostate, NSCLC, etc.) with prior histologic confirmation, ECOG 0-2, adequate organ function, and measurable disease (for dose expansion). Exclusions include uncontrolled CNS metastases, active infections, significant cardiac history, recent stroke/TIA, uncontrolled hypertension, anticoagulant use, and pregnancy/lactation. Prior therapies must be completed ≥30 days before enrollment.

Eligible patients must have relapsed/refractory solid tumors (ovarian, prostate, NSCLC, etc.) with prior histologic confirmation, ECOG 0-2, adequate organ function, and measurable disease (for dose expansion). Exclusions include uncontrolled CNS metastases, active infections, significant cardiac history, recent stroke/TIA, uncontrolled hypertension, anticoagulant use, and pregnancy/lactation. Prior therapies must be completed ≥30 days before enrollment.

ASN004 was evaluated for efficacy in human tumor mouse xenograft models,derived from four different human tumor cell types,having a wide range of 5T4 expression levels. ASN004 was further evaluated in a tumor xenograft model derived from the H1975 human lung carcinoma cell line [5T4+; 15, 800 binding sites per cell]. Subcutaneous tumor xenografts were developed in nude mice with established mean tumor volumes of 150 mm³. The dose of PF-06263507 was 3 mg/kg Q4D 4.

ASN004 was evaluated for efficacy in human tumor mouse xenograft models,derived from four different human tumor cell types,having a wide range of 5T4 expression levels. ASN004 was further evaluated in a tumor xenograft model derived from the H1975 human lung carcinoma cell line [5T4+; 15, 800 binding sites per cell]. Subcutaneous tumor xenografts were developed in nude mice with established mean tumor volumes of 150 mm³. The dose of PF-06263507 was 10 mg/kg Q4D 4.

The study assessed dose-limiting toxicities (DLTs) occurring within the first treatment cycle (21 days), including severe neutropenia, febrile neutropenia, thrombocytopenia with bleeding, non-hematologic toxicities, or cardiac troponin abnormalities. AEs were graded per CTCAE v4.0, and persistent toxicity delaying treatment by >2 weeks was considered a DLT.

Treatment-emergent adverse events (TEAEs) and treatment-related AEs were monitored from baseline through treatment cycles and follow-up, with severity graded per NCI CTCAE v4.0. Hematologic, chemistry, and urine protein abnormalities were tracked, along with vital sign changes meeting predefined criteria. Anti-drug antibodies and pharmacokinetic parameters (Tmax for PF-06263507 and metabolites) were also evaluated.

Secondary outcomes include adverse events (AEs) and lab abnormalities graded by NCI CTCAE v4.03, Objective Response Rate (ORR), duration of Complete Response (CR) and Objective Response (OR) up to 27.9 months, Progression-Free Survival (PFS) and Overall Survival (OS) tracked up to 30 months, alongside PBSC mobilization success and autologous stem cell transplant (ASCT) rates post-treatment.

Secondary outcomes include adverse events (AEs) and lab abnormalities graded by NCI CTCAE v4.03, Objective Response Rate (ORR), duration of Complete Response (CR) and Objective Response (OR) up to 27.9 months, Progression-Free Survival (PFS) and Overall Survival (OS) tracked up to 30 months, alongside PBSC mobilization success and autologous stem cell transplant (ASCT) rates post-treatment.

Eligible patients had untreated systemic DLBCL (de novo or transformed) or Grade 3b FL with high-intermediate/high-risk disease, measurable FDG-avid lesions, ECOG ≤2, and adequate baseline labs. Exclusions included prior lymphoma treatment, untreated CNS involvement, active cancers not in 3-year remission, PML history, or significant ocular conditions.

An Open Label Phase 2 Study of Denintuzumab Mafodotin (SGN-CD19A) in Combination With RCHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone) or RCHP (Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone) Compared With RCHOP Alone as Frontline Therapy in Patients With Diffuse Large B-cell Lymphoma (DLBCL) or Follicular Lymphoma (FL) Grade 3b