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

Quebec becomes first province in Canada to list new subcutaneous OPDIVO on public drug plan for solid tumour indications (Canada Newswire) - "By easing infusion chair demand and enabling adaptable care delivery, especially in settings with limited capacity or for remote patient populations, OPDIVO SC optimizes resources, enhances operational capacity, and provides more sustainable access to novel cancer care for patients."

dMMR • MSI-H • Reimbursement • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Melanoma • Non Small Cell Lung Cancer • Renal Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

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 (JADPRO 2025) - "Baseline demographics and disease characteristics were generally balanced between the two arms (Table 1). PK NI of NIVO SC vs NIVO IV was confirmed for C_trough at cycle 3 day 1 (Table 2). Efficacy: NI for ORR was confirmed for NIVO SC vs NIVO IV in the overall population (ORR: 15.8% vs 17.5%)."

Clinical • Metastases • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Nivolumab (NIVO) plus ipilimumab (IPI) vs chemotherapy (chemo) or NIVO monotherapy for microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) metastatic colo-rectal cancer (mCRC): expanded analyses from CheckMate 8HW (JADPRO 2025) - P3 | "Introduction • In the phase 3 CheckMate 8HW study, nivolumab plus ipilimumab (NIVO + IPI) demonstrated superior progression-free survival (PFS) vs chemotherapy (chemo) in the first-line (1L) setting [hazard ratio (HR), 0.21; 95% confidence interval (CI), 0.14-0.32; P < 0.0001] and superior PFS vs NIVO across all lines (HR, 0.62; 95% CI, 0.42-0.78; P = 0.0005) in no new safety signals in patients with incurable confirmed microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) metastatic colorectal cancer (mCRC).¹ • These results led to the approval of NIVO + IPi in the IL setting in patients with MSI-H/dMMR mCRC in the United States (US), European Union, and other countries.5,6 • Here, we report expanded analyses of NIVO + IPI vs NIVO across all lines and longer follow-up results for NIVO + IPI vs chemo in the IL setting. • No new safety signals were observed with NIVO + IPI, and most TRAEs with potential immunologic etiology emerged within the..."

dMMR • Metastases • Mismatch repair • Monotherapy • MSI-H • Colorectal Cancer • Microsatellite Instability • Oncology • Solid Tumor • MSI

Sales of its top cancer immunotherapy, Opdivo, rose 7% to $2.53 billion, and the newer subcutaneously injected version of the drug added another $67 million. (Yahoo Finance)

Sales • Bladder Cancer • Colorectal Cancer • Cutaneous Melanoma • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Hepatocellular Cancer • Lung Non-Small Cell Squamous Cancer • Malignant Pleural Mesothelioma • Microsatellite Instability • Renal Cell Carcinoma • Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck

Pharmacokinetics and safety of subcutaneous nivolumab: results from the phase I/II CheckMate 8KX study. (PubMed, J Immunother Cancer) - P1/2 | "The pharmacokinetics of nivolumab SC have been well characterized and enabled dose selection for further study. Nivolumab SC has an acceptable safety profile, allows for rapid administration, and is preferred by more patients than nivolumab IV. These results encourage large-scale investigation of nivolumab SC."

Journal • P1/2 data • PK/PD data • Oncology • Solid Tumor

Model-Informed Drug Development of Subcutaneous Nivolumab: Comparison of Pharmacokinetic Analysis Methodologies Using Clinical Trial Simulation. (PubMed, CPT Pharmacometrics Syst Pharmacol) - P3 | "In conclusion, both the $PRIOR and pooled population pharmacokinetic methods yielded more accurate results compared to conventional NCA. The MIDD approach was validated as a robust and feasible method to support non-inferiority assessment based on clinical trial simulations."

Journal • PK/PD data • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Bristol Myers Squibb Canada (BMS) today announced that the Institut national d'excellence en santé et en services sociaux (INESSS) has issued a positive recommendation for the reimbursement of OPDIVO SC (nivolumab for subcutaneous injection) in Quebec across Health Canada-authorized solid tumour indications where OPDIVO (nivolumab) for intravenous infusion is reimbursed. (Canada Newswire) - "The INESSS recommendation builds on the recognized therapeutic value of intravenous OPDIVO and reflects confidence in the clinical efficacy and safety of OPDIVO SC."

MSI-H • Reimbursement • Bladder Cancer • Classical Hodgkin Lymphoma • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Esophageal Squamous Cell Carcinoma • Gastric Adenocarcinoma • Gastroesophageal Junction Adenocarcinoma • Head and Neck Cancer • Melanoma • Mesothelioma • Microsatellite Instability • Non Small Cell Lung Cancer

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines), the NCCN Radiation Therapy Compendium, and the NCCN Imaging Appropriate Use Criteria (NCCN Imaging AUC) for Bone Cancer, Version 1.2026. (NCCN)

NCCN guideline • Bone Cancer

Opdivo Qvantig + Yervoy: Data readout from P2 CheckMate-1533 trial (NCT06946797) for 1L NSCLC in 2027 (Bristol-Myers Squibb) - Q2 2025 Results

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

A Phase I Study of ONO-4538HSC in Subjects With Advanced or Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=31 | Active, not recruiting | Sponsor: Ono Pharmaceutical Co. Ltd | Recruiting ➔ Active, not recruiting

Enrollment closed • Solid Tumor

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 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

CheckMate 67T: A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread (clinicaltrials.gov) - P3 | N=632 | Active, not recruiting | Sponsor: Bristol-Myers Squibb | Trial completion date: Jan 2026 ➔ May 2027

Head-to-Head • Trial completion date • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

A pilot single-arm, pragmatic trial in progress of in-home versus in-clinic subcutaneous nivolumab administration through Cancer Care (connected access and remote expertise) Beyond Walls (CCBW) program. (ASCO 2025) - P2 | "To date, 10 patients have been enrolled, and final analysis is expected 2.5 years after trial activation. Clinical trial information: NCT06265285"

Oncology

Subcutaneous nivolumab: Advancing operational efficiency and patient-centred care in the NHS. (PubMed, J Oncol Pharm Pract) - No abstract available

Journal

New Subcutaneous Formulation of OPDIVO Approved in Canada for Use Across All Authorized Solid Tumour Indications (Canada Newswire) - "Bristol Myers Squibb Canada (BMS) today announced that Health Canada has approved OPDIVO SC (nivolumab for subcutaneous injection) across all currently authorized solid tumour indications in monotherapy, in the maintenance phase following combination with ipilimumab (YERVOY), and in combination regimens with chemotherapy or tyrosine kinase inhibitors, consistent with the indications approved for the intravenous formulation. This new subcutaneous formulation is administered every two, three, or four weeks. OPDIVO SC should not be used in combination concurrently with YERVOY…This additional treatment delivery method provides clinicians and patients flexibility and convenience across multiple tumour types, including melanoma, renal cell carcinoma, gastric cancer, and other solid tumours."

Canada approval • Colorectal Cancer • Esophageal Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Melanoma • Non Small Cell Lung Cancer • Renal Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

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 • Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Urothelial Cancer

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 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

NHS becomes first health service in Europe to offer new cancer jab (Yahoo News) - "The NHS is rolling out an injectable form of the immunotherapy nivolumab, which can be given in three to five minutes and works for 15 different cancers, such as lung, bowel, kidney, bladder, oesophageal, skin and head and neck cancer....At present, patients need to be in hospital for a 30 or 60-minute infusion every two to four weeks. Under the change, patients will still go to hospital but the jab will be administered in just a few minutes. NHS England said the roll-out will save more than a year’s worth of treatment time for patients and NHS teams every year, freeing up staff for more appointments and making care swifter for patients."

Reimbursement • Bladder Cancer • Colorectal Cancer • Esophageal Cancer • Head and Neck Cancer • Lung Cancer • Renal Cell Carcinoma • Skin Cancer

MHRA authorises cancer treatment variation with an administration time of 3–5 minutes (GOV.UK) - "The Medicines and Healthcare products Regulatory Agency (MHRA) has today (30 April 2025) approved a new under-the-skin injection version of the cancer therapy, nivolumab (Opdivo), offering a quicker administration option for eligible patients....The subcutaneous formulation of nivolumab can be given as a 3–5-minute injection instead of the 30- or 60-minute intravenous (IV) infusion. Several common cancers can be treated by nivolumab, including lung, bowel, kidney, bladder, oesophageal, skin, and head and neck cancers....Today’s national approval is based on evidence from a randomised, open-label Phase 3 clinical trial, involving patients with advanced or metastatic clear cell renal cell carcinoma."

MHRA approval • Bladder Cancer • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Esophageal Cancer • Head and Neck Cancer • Kidney Cancer • Lung Cancer • Skin Cancer

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines), the NCCN Drugs & Biologics Compendium (NCCN Compendium), the NCCN Radiation Therapy Compendium, and the NCCN Imaging Appropriate Use Criteria (NCCN Imaging AUC) for Gastric Cancers, Version 1.2025. (NCCN)

NCCN guideline • Gastric Cancer • Microsatellite Instability

NCCN has published updates to the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Merkel Cell Carcinoma, Version 2.2025. (NCCN)

NCCN guideline • Merkel Cell Carcinoma

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 primary completion date: Aug 2025 ➔ Apr 2025

Trial primary completion date • Melanoma • Oncology • Solid Tumor

Subcutaneous Nivolumab Sustains Comparable Efficacy, Safety to IV Formulation in Advanced ccRCC (OncLive) - P3 | N=632 | CheckMate-67T (NCT04810078) | Sponsor: Bristol-Myers Squibb | "Nivolumab and hyaluronidase-nvhy (Opdivo Qvantig; subcutaneous nivolumab) demonstrated comparable efficacy, safety, and tolerability vs intravenous (IV) nivolumab (Opdivo) in patients with previously treated, advanced or metastatic clear cell renal cell carcinoma (ccRCC), according to updated results from the phase 3 CheckMate-67T trial (NCT04810078) presented during the 50th Annual Oncology Nursing Congress...Results showed that at a minimum follow-up of 15 months, the overall response rate (ORR) was 27% for subcutaneous nivolumab (n = 248) vs 21% for IV nivolumab (n = 247). ORR was a key secondary end point powered for noninferiority. Notably, the study previously met its co-primary end points of time-averaged serum concentration over the first 28 days and minimum serum concentration at steady state during the primary analysis."

P3 data • Clear Cell Renal Cell Carcinoma

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 • Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck • Squamous Cell Skin Cancer • Urothelial Cancer

CheckMate 67T: A Study of Subcutaneous Nivolumab Versus Intravenous Nivolumab in Participants With Previously Treated Clear Cell Renal Cell Carcinoma That is Advanced or Has Spread (clinicaltrials.gov) - P3 | N=632 | Active, not recruiting | Sponsor: Bristol-Myers Squibb | Recruiting ➔ Active, not recruiting

Enrollment closed • Head-to-Head • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor