A notable development has occurred in the initial treatment of colorectal cancer, as Bristol Myers Squibb receives FDA approval for the supplemental biologics license application (sBLA) of Opdivo (nivolumab) in combination with cisplatin-based chemotherapy.
This combination is designated as the principal therapy for adult patients managing unresectable or metastatic urothelial carcinoma. The regulatory decision is anticipated by April 5, 2024, building on results from the phase III CHeckMate-901 study, which demonstrated statistically significant and clinically meaningful survival advantages compared to the standard-of-care gemcitabine plus cisplatin.
Opdivo, Bristol Myers’ PD-1 immune checkpoint inhibitor, initially approved in 2014 for unresectable or metastatic melanoma, has gained global authorization as both a standalone treatment and in combination with Yervoy for various cancer indications. It has played a significant role in the company’s growth. Notably, Opdivo’s adjuvant use has recently been expanded by the FDA to include the treatment of completely resected stage IIB or IIC melanoma, supported by outcomes from the phase III CheckMate-76K study.
The concurrent use of Opdivo and cisplatin demonstrated good tolerability, consistent with the established safety profiles of the individual components. No new safety concerns emerged during the advanced stages of the study. Bristol Myers is actively involved in the phase III CheckMate-901 trial, evaluating the effectiveness of the Opdivo/Yervoy combination, followed by Opdivo monotherapy, compared to standard-of-care chemotherapy for patients with untreated, unresectable, or metastatic urothelial cancer.
The interim examination of the trial, involving 830 patients divided into three groups, successfully achieved one of its main goals, as assessed by Blinded Independent Central Review (BICR). Dana Walker, M.D., BMS’s global program lead, emphasized the outcomes as additional confirmation of the combination’s advantages in treating colorectal cancer, aligning with findings from the preceding CheckMate-142 study.
Opdivo has also shown success in the adjuvant treatment of adult and pediatric patients with melanoma involving lymph nodes or metastatic disease after complete resection. Simultaneously, Bristol Myers’ combination of Opdivo and Yervoy has shown encouraging results in a phase 3 trial focused on specific first-line colorectal cancer patients.
The CheckMate-8HW study, which explored individuals with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer, disclosed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) when compared to conventional chemotherapy. The sustained anti-tumor activity of Opdivo and Yervoy was evident in patients who had encountered progression following combination chemotherapy involving fluoropyrimidine.
Opdivo, Bristol Myers’ second-best-selling drug after the blood thinner Eliquis, generated $8.2 billion in revenue last year, marking a 10% increase over 2021. Yervoy contributed to this success with $2.1 billion in revenue, a 5% increase.
Bristol Myers reported $6.6 billion in Opdivo sales worldwide for the first nine months ending September 30, 2023.
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