Merck aims for first line kidney cancer use for Keytruda combo

Merck & Co is to request licences for its Keytruda immunotherapy in kidney cancer, following trial results showing that it improved survival in combination with Pfizer’s Inlyta compared with standard care.

Merck tested Keytruda (pembrolizumab) in combination with Inlyta (axitinib) in untreated advanced or metastatic renal carcinoma.

This is a potential new indication for the blockbuster immunotherapy, which has been approved in a raft of different cancer indications since it first hit the market in 2014.

Merck said it plans to file results of the phase III KEYNOTE-426 trial with regulators worldwide.

Bristol-Myers Squibb’s arch rival PD-1 checkpoint inhibitor drug Opdivo (nivolumab) has already been approved in first-line kidney cancer use.

So approval in this indication would allow Merck to try to compete for market share with BMS in yet another indication.

The trial’s dual endpoint of overall survival and progression free survival will allow Merck to argue that the combination not only keeps patients alive, but can prevent the disease from spreading, something not seen in previous kidney cancer trials.

Keytruda has overtaken Opdivo in sales, after it was approved in first-line lung cancer, an indication where Opdivo has not produced convincing results.

In the KEYNOTE-426 trial, the companies said Keytruda plus Inlyta resulted in statistically significant and clinically meaningful improvement in its two main goals of overall survival and progression-free survival compared with Pfizer’s Sutent (sunitinib).

There was also significant improvement in overall response rate, compared with Inlyta, an important secondary goal.

Results for these goals were consistent, regardless of expression of the PD-L1 biomarker on patients’ tumours.

Safety-wise there were no surprises, with Merck reporting that side-effects were consistent with those seen in previous reported studies for each therapy.

[caption id="attachment_24785" align="alignnone" width="131"] Roger Perlmutter[/caption]

Roger Perlmutter, president of Merck Research Laboratories, said: “This marks the first time that combination treatment with an anti-PD-1 therapy has achieved the dual primary endpoints of overall survival and progression-free survival as first-line therapy in advanced renal cell carcinoma.”

“Fewer than 10% of those diagnosed with advanced renal cell carcinoma survive for five years, and hence there is significant need for improved therapies for this disease. We are very grateful to the investigators and patients for their involvement in this important study, the results of which will be filed with global regulatory authorities in the near future.”