It's a script that is so often repeating itself over the past year. Bristol-Myers Squibb (NYSE:BMY) announces yet another step forward for nivolumab. After approvals in melanoma, lung cancer, renal cancer, and Hodgkin lymphoma, and highly favorable findings in colorectal and bladder cancers, BMY has become a leader in the space that it revolutionized with the first approval of ipilimumab back in 2011.
On July 18, BMY issued a press release stating that its filing for nivolumab in relapsed head and neck cancer has been granted priority review by the FDA, which may signal enthusiasm on the part of regulatory bodies.
This isn't surprising, since head and neck cancer remains its own difficult-to-treat entity that has historically had few treatment options beyond chemotherapy. Immune checkpoint inhibitors strike a blow again, and it looks like patients will be the beneficiaries!
What we know so far
The development of nivolumab in head and neck cancer has had a few major milestones. First, we've seen data from clinical trials like CheckMate 141, as recently as ASCO 2016. In this phase 3 study, nivolumab was compared to investigator's choice of chemotherapy for patients with previously treated recurrent or metastatic head and neck cancer. Patients with PD-L1-positive disease (in this analysis) had a substantial improvement in both response rate and overall survival.
Furthermore, nivolumab carried a smaller risk of serious adverse events than did chemotherapy treatment. Around 14% of nivolumab-treated patients had a grade 3 or higher event, compared with 35% for the chemotherapy-treated patients.
This past April, the results of CheckMate-141 led to the breakthrough therapy designation for nivolumab in this disease on the basis of overall survival improvement.
What this means for BMY
Priority review, a near doubling of overall survival over chemotherapy, and breakthrough therapy designation strongly suggest that we will see approval of nivolumab in this disease. Head and neck disease afflicts some 42,000 people in the United States every year, and 20-30% of these patients will develop metastatic disease. This means that the patients who may benefit from nivolumab in the anticipated indication could be over 10,000, which represents a potential market size in the billions of dollars for BMY, assuming the $300,000 annual cost per patient.
It also continues the story of immune checkpoint inhibitor emergence as a standard treatment option across a broad spectrum of tumors. One after one, difficult-to-treat forms of cancer, malignancies that have relied solely on chemotherapy for 20 or more years, are finally achieving more favorable results.
On top of that, the tolerability is even better than chemotherapy, which is a welcome relief after watching a decade of targeted therapy trials force a grim decision for clinicians balancing quality of life concerns with possible efficacy.
What we're seeing unfold is a game-changer in oncology, one step at a time. I think head and neck is going to be one of the next dominoes to fall, and BMY should be able to reap significant benefit from these gains.
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