Phase 3 Trial Findings Support Nivolumab Treatment in Multiple Cancer Types


Trial data bolster the role of nivolumab and nivolumab-based combinations in both early and metastatic stages of multiple cancer types, especially in patient groups with high unmet needs.

Bristol Myers Squibb announced the presentation of data from more than 55 collaborative studies across their oncology portfolio in 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 in ESMO Presidential Symposium sessions.

Consultation between physician and patient

Image credit: prachid |

The trial findings support the role of nivolumab (Opdivo; Bristol Myers Squibb) and nivolumab-based combinations in both earlier and metastatic stages of multiple cancer types. Additional research is needed to highlight the potential of repotrectinib in patients with TKI-naïve and -pretreated NTRK-positive solid tumors (eg, non-small cell lung cancer [NSCLC]), as well as the benefit of treatment with the fixed-dose combination of nivolumab and the LAG-3-blocking antibody relatlimab-rmbw (Opdulag; Bristol Myers Squibb).

Nivolumab is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to utilize the body’s immune system to help restore anti-tumor immune response and fight cancer. It has become an important treatment option across multiple cancers. 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, NSCLC, unresectable malignant pleural mesothelioma, advanced renal cell carcinoma, classical Hodgkin lymphoma, and urothelial carcinoma.

“We are eager to share research during this year’s ESMO Congress on our immunotherapies and targeted therapies in both metastatic disease and earlier stages of several tumor types, including bladder cancer, melanoma and lung cancer,” said Samit Hirawat, MD, executive vice president, chief medical officer, global drug development of Bristol Myers Squibb.

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

Data from these trials will be presented on October 22 and October 21, respectively. Additional phase 3 trials with nivolumab demonstrated efficacy when treating patients with resectable NSCLC, NTRK-positive advanced solid tumors, and both early and advanced stages of melanoma.

Potential adverse effects (AEs) of nivolumab include immune-mediated pneumonitis, colitis, hepatitis and hepatotoxicity, endocrinopathies (eg, thyroid disorders, adrenal insufficiency, hypophysis, diabetes), nephritis with renal dysfunction, and dermatologic complications (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug rash). Nivolumab may also cause infusion-related AEs and embryo-fetal toxicity in individuals who are pregnant. Some serious AEs such as abdominal pain, hyponatremia, increased lipase, and increased aspartate aminotransferase were reported by trial participants; however, the most common AEs were rash, fatigue, diarrhea, nausea, vomiting, decreased appetite, cough, and headache.

“These new data highlight our leading development program from [nivolumab] and [nivolumab]-based combinations in earlier stages of cancer, as well as our commitment to meeting the challenging treatment needs of cancer patients by both continuing to study the potential of our existing medicines as well as advancing new assets that may target cancer’s vulnerabilities more precisely,” said Hirawat at the press release.


Bristol Myers Squibb. Bristol Myers Squibb to Showcase Data Demonstrating Improved Outcomes in Earlier Stages of Cancer, Durable Long-Term Benefits with Opdivo-Based Regimens, and Addressing High Unmet Needs in Multiple Tumor Types at ESMO 2023. News release. October 12, 2023. Accessed October 12, 2023.

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