Merck hot on the heels of BMS in lung cancer race

Bristol-Myers Squibb (BMS) has claimed another first in the close-fought battle for supremacy in the PD-1 inhibitor market after its Opdivo drug showed a survival advantage in lung cancer.

The results of the CheckMate-017 study were impressive enough to warrant closing it down early, with patients on Opdivo (nivolumab) showing superior overall survival compared to standard therapy with docetaxel.

The trial involved previously treated patients with advanced or metastatic squamous cell non-small cell lung cancer (NSCLC), a much-larger patient group than addressed by Opdivo’s current indication in the skin cancer melanoma. BMS has not revealed full details from the trial but says it will do so at a medical conference later this year.

Showing a survival advantage puts Opdivo clinically a little ahead of arch-rival Keytruda (pembrolizumab) from Merck & Co, which was the first PD-1 inhibitor to reach the US market even though Opdivo claimed the first for the class in Japan.

Moreover, it reinforces data from the earlier placebo-controlled Checkmate-063 trial, which was reported last October and revealed a one-year survival rate of 41 per cent for BMS’ drug, and increases the chances of a positive review from the FDA in lung cancer.

However, no sooner had BMS revealed its new data than Merck announced that it will submit its marketing application for Keytruda in NSCLC in mid-2015, as it tries to regain its first-mover advantage over BMS in the important US market.

With an FDA promise to review its application within six months already in hand, Keytruda could be approved in NSCLC before the end of the year, around 12 months earlier than expected.

BMS has already filed for NSCLC approval in both the US and Europe based on the results of the Checkmate-063 study so should get a green light before its rival, although its lead could now be cut dramatically. Of course, the new survival data reinforces the chances of a successful review by the FDA.

Meanwhile, BMS is also gearing up to report data from another NSCLC study called Checkmate-057, while Merck is waiting for the results of Keynote-010, which could both provide further insights into how the two leading PD-1 inhibitors will compete in lung cancer.

Analysts have previously predicted that the market for PD-1 inhibitors could eventually reach a whopping $25-$30 billion, although Goldman Sachs said recently it expects the figure to be nearer the $10 billion-$15 billion range.

It also expects Opdivo to lead the category and become a $7 billion product by 2025, jostling for market share with not only Keytruda but also other PD-1 candidates, including Roche’s MPDL3280A, AstraZeneca’s MEDI4736 and other experimental drugs from Pfizer/Merck KGaA and Novartis.


New collaboration with Lilly

BMS has also just announced a new collaboration with Lilly, with the companies working together on a combination of Opdivo and Lilly’s pipeline molecue galunisertib.  The phase 1/2 trial will evaluate the drugs in combination against advanced (metastatic and/or unresectable) glioblastoma, hepatoceullar carcinoma and non-small cell lung cancer.

Such combinations are expected to become a mainstay of treatment across various cancers in order to produce the best results, and companies in the field already have a huge range of different immunotherapy combinations in trials.  Lilly’s galunisertib selectively inhibits TGF beta R1 kinase, a protein which promotes tumour growth.


BMS gets go-ahead for PD-1 inhibitor Opdivo in US


A breakthrough in lung cancer – the biggest prize in immunotherapy

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