Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) / BMS, Ono Pharmaceutical, Halozyme - LARVOL DELTA

Model-based clinical pharmacology profiling of subcutaneous nivolumab in renal cell carcinoma: Bridging to alternative dosing regimens and indications. (PubMed, Clin Pharmacol Ther) - P3 | "The MIDD approach provided an integrated and computationally efficient framework to characterize nivolumab SC/IV PK. Simulation-based analyses confirmed comparable benefit-risk profiles of nivolumab SC in adults across solid tumor indications and led to FDA approval of nivolumab SC in existing adult IV indications (except for nivolumab in combination with ipilimumab)."

Journal • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Subcutaneous (SC) nivolumab (NIVO) vs intravenous (IV) NIVO in patients with previously treated advanced or metastatic clear cell renal cell carcinoma (ccRCC): Safety and patient-reported outcomes (PROs) of the randomized phase 3 CheckMate 67T trial. (ASCO 2024) - P3 | "The safety profile of SC was consistent with IV, supporting the use of NIVO SC as an option improving patient experience. This aligns with patient preference for SC administration over IV. Analyses based on weight and ADA subgroups were consistent with the known NIVO safety profile."

Clinical • Metastases • P3 data • Patient reported outcomes • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Immunology • Oncology • Solid Tumor

Subcutaneous nivolumab (NIVO SC) vs intravenous nivolumab (NIVO IV) in patients (pts) with previously treated advanced or metastatic clear cell renal cell carcinoma (ccRCC): Updated efficacy and safety results from CheckMate 67T (ESMO 2024) - P3 | "Efficacy and safety profiles of NIVO SC in this analysis are comparable to those of NIVO IV, consistent with the primary analysis. Immunogenicity data were consistent with the primary analysis. These updated results continue to support NIVO SC as a new option to improve pt experience and healthcare efficiency."

Clinical • Metastases • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Solid Tumor

A Study of ONO-4538HSC in Pediatric Patients With Malignant Solid Tumors and in Patients With Epithelioid Sarcoma. (clinicaltrials.gov) - P1/2 | N=50 | Recruiting | Sponsor: Ono Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Oncology • Pediatrics • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Subcutaneous versus intravenous nivolumab for renal cell carcinoma. (PubMed, Ann Oncol) - P3 | "Subcutaneous nivolumab was noninferior to intravenous nivolumab based on pharmacokinetics and ORR. No new safety signals were observed."

Journal • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Subcutaneous nivolumab (NIVO SC) vs intravenous nivolumab (NIVO IV) in patients with previously treated advanced or metastatic clear cell renal cell carcinoma (ccRCC): Pharmacokinetics (PK), efficacy, and safety results from CheckMate 67T. (ASCO-GU 2024) - P3 | "The co-primary PK and key powered secondary ORR endpoints were met, supporting the use of NIVO SC as a new option to improve healthcare efficiency. The safety profile for NIVO SC was consistent with NIVO IV. Clinical trial information: NCT04810078.aNoninferiority = lower bound 90% CI ≥ 0.8; bNoninferiority = lower bound 95% CI ≥ 0.6."

Clinical • Late-breaking abstract • Metastases • PK/PD data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

A Study to Evaluate Whether Participants With Melanoma Prefer Subcutaneous vs Intravenous Administration of Nivolumab and Nivolumab + Relatlimab Fixed-dose Combinations (clinicaltrials.gov) - P2 | N=100 | Active, not recruiting | Sponsor: Bristol-Myers Squibb | Trial completion date: Aug 2027 ➔ Feb 2027

Trial completion date • Melanoma • Oncology • Solid Tumor

A Study of ONO-4538HSC in Pediatric Patients With Malignant Solid Tumors and in Patients With Epithelioid Sarcoma. (clinicaltrials.gov) - P1/2 | N=50 | Not yet recruiting | Sponsor: Ono Pharmaceutical Co., Ltd.

New P1/2 trial • Oncology • Pediatrics • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Axelopran and Nivolumab in PD-1-Refractory Metastatic Melanoma (clinicaltrials.gov) - P1/2 | N=28 | Not yet recruiting | Sponsor: John Kirkwood | Initiation date: Jul 2026 ➔ Oct 2026

First-in-human • Trial initiation date • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor

Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer (clinicaltrials.gov) - P3 | N=718 | Recruiting | Sponsor: SWOG Cancer Research Network | Not yet recruiting ➔ Recruiting

Enrollment open • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Treatment Patterns and Characteristics of Patients Prescribed Opdivo Qvantig (clinicaltrials.gov) - P=N/A | N=200 | Completed | Sponsor: Bristol-Myers Squibb

New trial • Oncology

Patient characteristics, treatment patterns, social determinants of health, and safety in patients prescribed nivolumab and hyaluronidase-nvhy by early adopters. (ASCO 2026) - "Among SC-treated patients, 54% initiated therapy in the first line setting, while remaining use reflected conversion from IV therapy, most commonly following nivo IV + ipilimumab induction, where SC administration is not currently indicated. In this early real-world community oncology analysis, nivo + hyal SC use demonstrated patient characteristics, treatment patterns, and safety comparable to nivo IV. Difference in proximity-to-care measures, including greater variability and longer travel distances among SC recipients, suggest SC administration may support treatment delivery for patients with higher geographic burden. Findings should be interpreted cautiously given the limited sample size but offer early insight into real-world adoption and access considerations for subcutaneous immunotherapy."

Clinical • Oral Cancer • Solid Tumor

Axelopran in Patients With Anti-PD-1 Refractory Metastatic or Locoregionally Unresectable Cutaneous Melanoma (clinicaltrials.gov) - P1/2 | N=28 | Not yet recruiting | Sponsor: John Kirkwood

First-in-human • New P1/2 trial • Cutaneous Melanoma • Melanoma • Oncology • Solid Tumor

Cost-Effectiveness Analysis of Sasanlimab plus BCG for High-Risk Non-muscle Invasive Bladder Cancer (NMIBC): Analysis From CREST (AUA 2026) - "Cost data for sasanlimab were extrapolated from subcutaneous nivolumab pricing ($24,225/dose), as sasanlimab is not currently FDA approved. At anticipated pricing consistent with currently available immunotherapy, sasanlimab is not cost effective as a combination therapy with BCG relative to BCG alone for patients with high-risk NMIBC. Further efforts are needed to improve the efficacy/toxicity profile of novel therapies in this disease space, while continued scrutiny of the healthsystem cost implications of new agents remains warranted."

Cost effectiveness • HEOR • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Opdivo Qvantig + Yervoy: Data readout from P2 CheckMate-1533 trial (NCT06946797) for 1L NSCLC in 2027 (Bristol-Myers Squibb) - Q1 2026 Results

P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology

CheckMate-1533: A Study to Evaluate Two Dosing Regimens of Subcutaneous Nivolumab in Combination With Intravenous Ipilimumab and Chemotherapy in Participants With Previously Untreated Metastatic or Recurrent Non-Small Cell Lung Cancer (NSCLC) (clinicaltrials.gov) - P2 | N=76 | Active, not recruiting | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Active, not recruiting

Enrollment closed • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • BRAF • NTRK • ROS1

Bristol Myers Squibb Receives European Commission Approval for the Subcutaneous Formulation of Opdivo (nivolumab) Across Multiple Solid Tumor Indications (Gurufocus) - "Bristol Myers Squibb...has announced that the European Commission (EC) has approved the subcutaneous (SC) formulation of Opdivo (nivolumab), making it the first PD-1 inhibitor approved for subcutaneous use within the European Union. This formulation offers a new route of administration as a solution for injection in a 600 mg/vial strength. The approval is based on Phase 3 results from the CheckMate -67T clinical trial...Opdivo SC has been approved for use in multiple adult solid tumors either as monotherapy, monotherapy maintenance following intravenous nivolumab plus Yervoy (ipilimumab) therapy, or in combination with chemotherapy or cabozantinib. The EC's decision permits the drug's use across the EU's 27 member states, as well as Iceland, Liechtenstein, and Norway."

EMA approval • Bladder Cancer • Colorectal Cancer • Cutaneous Melanoma • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Hepatocellular Cancer • Hodgkin Lymphoma • Malignant Pleural Mesothelioma • Microsatellite Instability • Non Small Cell Lung Cancer • Renal Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Urothelial Cancer

Ascierto: “Subcutaneous nivolumab is a win-win for both the system and patients.“ (La Milano) - "'The availability of the subcutaneous formulation 'allows for streamlining procedures and reducing the workload of day hospitals, while maintaining the effectiveness of the treatment.'"

dMMR • MSI-H • Reimbursement • Bladder Cancer • Classical Hodgkin Lymphoma • Colorectal Cancer • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Hepatocellular Cancer • Malignant Pleural Mesothelioma • Melanoma • Microsatellite Instability • Non Small Cell Lung Cancer • Renal Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Bristol Myers Squibb Announces Updated Action Date by the U.S. Food and Drug Administration for Subcutaneous Nivolumab (nivolumab and hyaluronidase) (Businesswire) - "Bristol Myers Squibb...announced that the U.S. Food and Drug Administration (FDA) has reassigned the previously announced Prescription Drug User Fee Act (PDUFA) goal date of the Biologics License Application (BLA) for the subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20) (herein referred to as 'subcutaneous nivolumab') across all previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib. The updated goal date is December 29, 2024. The application is based on results from CheckMate -67T, the first Phase 3 trial of the subcutaneous formulation of nivolumab to evaluate and demonstrate noninferior pharmacokinetics, efficacy and consistent safety vs. its intravenous formulation."

BLA • PDUFA • Bladder Cancer • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Cutaneous Melanoma • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Hepatocellular Cancer • Hodgkin Lymphoma • Malignant Pleural Mesothelioma • Microsatellite Instability • Non Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Urothelial Cancer

U.S. Food and Drug Administration Accepts Bristol Myers Squibb’s Application for Subcutaneous Nivolumab (nivolumab and hyaluronidase) (Businesswire) - "Bristol Myers Squibb...today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for the subcutaneous formulation of Opdivo (nivolumab) co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20) (herein referred to as 'subcutaneous nivolumab') across all previously approved adult, solid tumor Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib. The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of February 28, 2025....The FDA filing acceptance is based on the Phase 3 CheckMate -67T study..."

BLA • PDUFA • Bladder Cancer • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Cutaneous Melanoma • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Hepatocellular Cancer • Hodgkin Lymphoma • Malignant Pleural Mesothelioma • Microsatellite Instability • Non Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Urothelial Cancer

Bristol Myers Squibb Receives Positive CHMP Opinion for the Subcutaneous Formulation of Opdivo (nivolumab) Across Multiple Solid Tumor Indications (Businesswire) - "Bristol Myers Squibb...announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of a new Opdivo (nivolumab) formulation associated with a new route of administration (subcutaneous use), a new pharmaceutical form (solution for injection) and a new strength (600 mg/vial). Nivolumab for subcutaneous use co-formulated with recombinant human hyaluronidase (rHuPH20), is indicated across multiple previously approved adult solid tumors as monotherapy, monotherapy maintenance following completion of nivolumab plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib....The positive CHMP opinion is based on results from the CheckMate -67T trial....A decision on the EU Opdivo extension of marketing authorization is expected by June 2, 2025."

CHMP • EMA approval • Bladder Cancer • Colorectal Cancer • Cutaneous Melanoma • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Hepatocellular Cancer • Hodgkin Lymphoma • Malignant Pleural Mesothelioma • Microsatellite Instability • Non Small Cell Lung Cancer • Renal Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Urothelial Cancer

CA2360001: A Phase 1/2 Study of BMS-986482 Alone or Combination Therapy in Participants with Advanced Solid Tumors (clinicaltrialsregister.eu) - P1/2 | N=62 | Recruiting | Sponsor: Bristol-Myers Squibb Services Unlimited Company

Monotherapy • New P1/2 trial • Breast Cancer • Colorectal Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer (clinicaltrials.gov) - P3 | N=718 | Not yet recruiting | Sponsor: SWOG Cancer Research Network

New P3 trial • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Bristol says new version of Opdivo on track to meet target (MSN News) - "Bristol Myers Squibb Co. said about 5% of Opdivo patients are taking a new, easier-to-use version of the blockbuster cancer drug and said it’s on course to meet the company’s goal of adoption by at least 30% of patients in two years....The new version started gaining more traction in the market this summer after the company gained a dedicated Medicare billing code that makes it easier for doctors to buy the drug and get reimbursed."

Commercial • Hematological Malignancies • Solid Tumor

Model-Based Alternative Dosing Strategies for Subcutaneous Nivolumab to Improve Cost Effectiveness. (PubMed, Clin Pharmacokinet) - "The developed dosing regimen with a bodyweight-dependent interval offers a cost-effective and patient-friendly method to optimize SC nivolumab use while ensuring adequate exposure, which can be directly implemented in clinical practice. Moreover, the two experimental progressive proposed regimens provide a rationale for a clinical non-inferiority study in which alternative dose regimens are compared to standard dosing according to the drug label."

HEOR • Journal • Melanoma • Oncology • Solid Tumor