Keeping pace with rival Keytruda, Bristol-Myers' Opdivo wins new breakthrough designation
- Earlier this week, Bristol-Myers Squibb (BMS) announced it had received breakthrough therapy designation for Opdivo (nivolumab) for secondary treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) after platinum-based therapy.
- The designation is based on the strength of data showing a one-year survival rate of 36% in Opdivo-treated patients, versus 17% for standard-of-care patients.
- Earlier this month, Merck's supplemental biologics license application for use of Keytruda (pembrolizumab) to treat head and neck cancers was accepted by the FDA.
Head and neck cancer is the seventh-most-prevalent cancer globally and it also is particularly deadly, with a less than 5% five-year survival rate for patients with metastatic stage IV disease. In addition, the incidence of squamous cell carcinoma of the head and neck (SCCHN) is on the rise. Global incidence is expected to increase by 17% between 2012 and 2022.
Both Keytruda and Opdivo show strong potential for extending life in patients with SCCHN. This is especially important considering there are no systemic therapies to use after platinum-based therapies have been exhausted.
In addition to Keytruda's strong one-year survival data, a phase 3 trial also showed a median overall survival time of 7.5 months in the phase IV treatment population, versus 5.1 months for standard of care. In addition, Keytruda was even more effective among patients with human papollomavirus (HPV). For these patients, the median survival rate in the Opdivo group was 9.1 months, verus 4.4 months for standard of care.
Currently, Opdivo is indicated for treatment of melanoma, lung cancer and kidney cancer, while Keytruda is indicated for melanoma and lung cancer. Overall, Opdivo has staked out a lead over Keytruda in total sales, but Merck's med could gain an edge with an earlier approval for SCHHN.
- Bristol-Myers Squibb Statement