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Merck surprise winner in PD-1 race

Published on 05/09/14 at 05:06am
Keytruda packshot
Keytruda is now available for US late-stage melanoma patients

Merck has become the first company to bring a new class of cancer drug to the US market after the FDA approved its melanoma treatment Keytruda (pembrolizumab) last night.

The US regulator has given the green light for the drug to treat patients with late-stage melanoma (the deadliest form of skin cancer) who are no longer responding to other drugs.

This means that Keytruda has not been given the more lucrative first-line licence, and is indicated for patients following treatment with Bristol-Myers Squibb’s immuno-oncology drug Yervoy (ipilimumab).

And for melanoma patients whose tumours express a gene mutation called BRAF V600, Keytruda is intended for use after treatment with both Yervoy and a BRAF inhibitor, such as Roche’s Zelboraf (vemurafenib) or GlaxoSmithKline’s Tafinlar (dabrafenib).

This will prove a very costly treatment option when all three drugs are combined. Merck has said its new medicine will cost $12,500 per month. With the average time of treatment being around six months, this will see a price tag of $75,000 (£46,000).

But when this is added to the costs of Yervoy (which costs $120,000 per course of treatment) and Zelboraf/Tafinlar, the prices of which are broadly similar to Keytruda, the total spent on treating one patient with advanced melanoma could tip $200,000.

This will most likely add to the already fierce debate on cancer drug pricing in the US, which over the past two years has seen doctors and insurers becoming more vocal on the issue.

The drug is expected to generate $1.5 billion in 2017 sales, according to analysts’ estimates.

Speedy approval

The FDA had not been expected to approve the medicine until the end of October, so this announcement will be a boost for Merck.

Greater still for the firm is the fact that Merck is the first pharma company to gain approval for a new class of cancer drug called a PD-1 inhibitor, which works as a type of immunotherapy.

The intravenous infusion is believed to work by blocking the interaction of PD-1 with its ligands PD-L1 and PD-L2, giving the body’s immune system more chance of recognising cancerous cells and killing them.

Close rival and fellow US native BMS had gained a licence for its PD-1 inhibitor Opdivo (nivolumab) in Japan last month, where it is priced at $143,000, and was expected to become a leader in this new class.

But BMS has not yet filed its drug in the US and has lagged behind Merck, which submitted its drug in January under an accelerated approval system.

BMS says that it will submit its drug to the FDA for patients with advanced melanoma by the end of the month and could have its treatment in the US by the second quarter of next year.

On top of this, it also expects to complete by the end of this year a rolling submission for FDA approval of Opdivo for certain patients with late-stage lung cancer. But it will still be second to market, and this could damage its overall sales prospects.

Roche and AstraZeneca also have PD-1 inhibitors in the pipeline, but neither are as advanced as Opdivo or Keytruda. Analysts expect this new market to be worth around $30 billion per year in the next decade, should all four drugs gain approval.

Merck submitted Keytruda to the EMA in July, with a decision on the drug expected early next year, meaning it could also be the first PD-1 to be approved in Europe.

Merck is studying the drug in more than 30 different types of tumours. The firm says it expects to present data from studies in lung, bladder and gastric cancers at a European medical meeting later this month.

Ben Adams

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