- Bristol-Myers Squibb's immunotherapy Opdivo extended survival times for patients with head and neck cancer, continuing a string of positive data which should help strengthen the drug's market position.
- After one year, 36% of patients taking Opdivo were alive, compared to just under 17% of patients who received other standard treatments, the company said on Tuesday. Head and neck cancer, if not successfully treated with surgery, has a particularly grim prognosis when it recurs.
- Earlier this week, Bristol-Myers released data showing over a third of patients who took Opdivo for treatment of advanced melanoma were alive after five years.
In a phase 3 trial, treatment with Opdivo led to a 30% reduction in the risk of death, with a median survival time of 7.5 months among patients taking the drug, compared to 5.1 months for those on other standard treatments.
"Squamous cell carcinoma of the head and neck that progresses after platinum-therapy is a devastating disease with a very poor prognosis. There are no systemic therapies that improve survival, and therefore, there is a tremendous unmet need for new treatment options for this patient population," said lead investigator Maura Gillison.
While improvement of a little over 2 months is significant, the doubling of one-year survival rates indicates Opdivo can have a more sustained impact in some patients. Immunotherapies like Opdivo and rival Merck's Keytruda are garnering a lot of attention from impressive results, but don't always work as well across all patients.
Opdivo is currently approved to treat non-small cell lung cancer, advanced melanoma, and kidney cancer. While Bristol-Myers has not submitted Opdivo for regulatory review in head and neck cancer, this data might support new indications in the future, according to Bloomberg. Merck, on the other hand, had its application for this patient population recently accepted by the FDA.
Data from the study showed Opdivo to have greater effectiveness among patients who were positive for human papillomavirus (HPV). For HPV-positive patients, median survival was 9.1 months among those treated with Opdivo versus 4.4 months for patients treated with investigator's choice of therapy. The drug still improved survival times in HPV-negative patients, but with a lower magnitude of effect.
Identifying which patient groups will benefit most from immunotherapies is a key challenge, given the wide range of responses.