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FDA approval for Merck’s Keytruda threatens Libtayo in skin cancer

Another registration trial of Libtayo is due to report in 2021

US FDA HQ

Merck & Co has claimed FDA approval for its checkpoint inhibitor Keytruda in cutaneous squamous cell carcinoma (cSCC), the second most common form of skin cancer, muscling in on territory held by Sanofi and Regeneron’s Libtayo.

The US regulator has approved Keytruda (pembrolizumab) as a monotherapy for patients with recurrent cSCC that can’t be treated with surgery or radiation therapy.

cSCC is the second most common human cancer in the US with an estimated annual incidence of approximately 700,000 cases. It usually develops in skin areas that have been regularly exposed to the sun or other forms of ultraviolet radiation.

Approval of Merck’s market-leading PD-1 inhibitor in this indication is a shot across the bows of Sanofi and Regeneron, which picked up FDA approval for Libtayo in cSCC – with a similar label claim – two years ago.

Libtayo was the sixth drug in the PD-1/PD-L1 inhibitor class to reach the market and faced an uphill task to gain ground on the established leaders. In its favour was a first-in-class approval in cSCC that allowed it to gain a foothold in the market free of direct competition.

Sales of Libtayo have been modest, however, coming in at $194m last year, with $176m of that total coming from the US market. In the first quarter of this year the drug added another $75m, signalling an uptick in momentum that could not be undermined by the Keytruda approval.

Keytruda – a $12bn blockbuster thanks to an ever-lengthening list of indications dominated by its use in non-small cell lung cancer – has been approved by the FDA on the strength of the phase 2 KEYNOTE-629 trial.

Merck’s drug achieved an objective response rate (ORR) of 34% in the study, including a complete response rate of 4% and a partial response rate of 31%. More than two thirds (69%) of patients had responses lasting six months or longer.

In Libtayo’s registration trial, 47% of all patients treated had their tumours shrink or disappear, although there’s no way to reliably compare results from different clinical trials.

cSCC is a relatively minor new indication for Keytruda but accounts for all of Libtayo’s sales at the moment, although Sanofi and Regeneron are working to expand the use of their drug.

They have new data in basal cell carcinoma that has progressed after first-line therapy with hedgehog inhibitors, and as a first line monotherapy for PD-L1 positive non-small cell lung cancer (NSCLC), that should support regulatory filings later this year.

Another registration trial of Libtayo plus chemo in first-line NSCLC, regardless of PD-L1 status, is due to report in 2021.

Article by
Phil Taylor

25th June 2020

From: Regulatory

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