Landmark Approval in Early-Stage Lung Cancer

From EndPoint News

On Feb. 28, the FDA accepted Bristol Myers Squibb’s application for approval of a new use of blockbuster checkpoint inhibitor Opdivo and said it would make a decision by July 13. This is a landmark approval for early-stage lung cancer as well as for Bristol Myers Squibb.

Landmark Approval Awarded in 5 Days

That estimate turned out to be conservative, to say the least. On Friday, just five days after accepting the application, the FDA OK’d it, handing the Big Pharma a landmark approval.

Opdivo can now be used to treat patients with early-stage non-small cell lung cancer prior to receiving surgery to remove their tumor. Although Opdivo and other PD-(L)1 inhibitors have already transformed treatment for more advanced forms of the disease, improving survival by replacing or supplementing toxic chemotherapy with more tolerable and effective molecules that take the “brakes” off the immune system, the drugs have yet to reach many of the earliest stage patients.

Opdivo’s new approval is part of a broader race by Big Pharmas to move their PD-(L)1 drugs into earlier lines of therapy, a push that experts say could continue to remake the standard-of-care treatment (along with companies’ pockets).

Early-Stage Lung Cancer Landmark Approval Helps BMS Gain Toehold on Merck

It’s also a key win for Bristol Myers, the #2 player in the checkpoint world, in gaining a toehold on Merck’s dominant position on the market. Although Bristol put the first PD-(L)1 drug on the market, it lost its preferred status among clinicians after failures in advanced non-small lung cancer, where Merck produced practice-changing results.

In the Phase III trial that led to approval, 388 patients with operable lung cancer were randomized to receive chemotherapy alone or chemotherapy plus Opdivo prior to surgery. Patients in the Opdivo arm went a median of 31.6 months without any type of recurrence, compared to 20.8 months for patients on chemo alone.

Just under a quarter of patients on Opdivo also saw pathologic complete response — biopsies with no signs of cancer under close inspection — compared to 2.2% of patients on chemo alone. Opdivo patients also appeared to live longer, although that number was not yet statistically significant.

Mark Awad, clinical director of the Lowe Center for Thoracic Oncology at the Dana-Farber Cancer Institute and a study investigator, said in a statement that the approval “marks a turning point in how we treat resectable NSCLC.”

Merck, of course, is now running its own trials in the same setting, as are other PD-(L)1 players such as Roche. They are all also competing to be first in early lines of therapy for other cancers.