Phase 3 trial results support Nivolumab in multiple cancer types

Bristol Myers Squibb announced the presentation of data from more than 55 collaborative studies across its oncology portfolio across more than 10 tumor types at the upcoming European Society for Medical Oncology (ESMO) Congress. Data from the Phase 3 CheckMate-901 and CheckMate-77T studies have been selected and will be presented at the ESMO President’s Symposium.

Trial results support the role of nivolumab (Opdivo; Bristol-Myers Squibb) and nivolumab-based combinations in early and metastatic stages across multiple cancer types. Additional studies are needed to highlight the potential of repotrectinib in the treatment of TKI-naïve patients with NTRK-positive solid tumors such as non-small cell lung cancer (NSCLC), as well as the benefit of fixed-dose therapy with nivolumab and LAG-3 blockade. The combination of blocking antibodies relatlimab-rmbw (Opdulag; Bristol Myers Squibb).

Nivolumab is a programmed death 1 (PD-1) immune checkpoint inhibitor designed to harness the body’s immune system to help restore anti-tumor immune responses and fight cancer. It has become an important treatment option for many types of cancer. In 2014, nivolumab became the first PD-1 immune checkpoint inhibitor to receive regulatory approval. It is indicated for the treatment of unresectable or metastatic melanoma, non-small cell lung cancer, unresectable malignant pleural mesothelioma, advanced renal cell carcinoma, classical Hodgkin lymphoma and urothelial carcinoma.

“We are eager to share our research on immunotherapies and targeted therapies in metastatic disease and early stages of multiple tumor types, including bladder cancer, melanoma and lung cancer, at this year’s ESMO Congress,” said Executive Vice President Samit Hirawat, MD explain. Chief Medical Officer, Global Drug Development, Bristol-Myers Squibb.

Overall survival and progression-free survival in the phase 3 CheckMate-901 trial of nivolumab plus cisplatin-based chemotherapy followed by nivolumab monotherapy in first-line treatment of patients with unresectable or metastatic urothelial carcinoma Phase 1 data suggest a survival benefit with cisplatin-based chemotherapy compared with standard therapy. Additionally, the phase 3 CheckMate-77T trial used neoadjuvant nivolumab plus chemotherapy followed by surgery and adjuvant nivolumab perioperative regimen in patients with resectable stage IIA to IIIB NSCLC.

Data from these trials will be released on October 22 and October 21 respectively. Additional Phase 3 trials of nivolumab have demonstrated efficacy in patients with resectable NSCLC, NTRK-positive advanced solid tumors, and early-stage and advanced melanoma.

Potential adverse effects (AEs) of nivolumab include immune-mediated pneumonitis, colitis, hepatitis and hepatotoxicity, endocrine disorders (e.g., thyroid disease, adrenal insufficiency, pituitary insufficiency, diabetes), nephritis with renal insufficiency and skin complications (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug eruptions). Nivolumab may also cause infusion-related AEs and embryo-fetal toxicity in pregnant individuals. Trial participants reported some serious adverse events, such as abdominal pain, hyponatremia, elevated lipase, and elevated aspartate aminotransferase; however, the most common adverse events were rash, fatigue, diarrhea, nausea, vomiting, Loss of appetite, cough, and headache.

“These new data underscore our leading development program with (nivolumab) and (nivolumab)-based combinations in early stages of cancer and our commitment to address the challenging treatment needs of cancer patients by continuing to investigate the potential of our existing medicines. drugs as well as advancing new assets that may more precisely target cancer vulnerabilities,” Hirawat said in a press release.

refer to

Bristol-Myers Squibb. Bristol-Myers Squibb will present data at ESMO 2023 demonstrating improved outcomes in early stages of cancer, durable long-term benefits of Opdivo-based treatment regimens, and addressing high unmet needs across multiple tumor types. Press release. October 12, 2023. Accessed 12 October 2023. https://news.bms.com/news/corporate-financial/2023/Bristol-Myers-Squibb-to-Showcase-Data-Demonstrating-Improved-Outcomes-in-Earlier – Cancer Stages