Merck KGaA and Pfizer have got the fourth checkpoint inhibitor to market after the US regulator approved their avelumab for a rare form of skin cancer.
The FDAs approval of avelumab, marketed as Bavencio, in metastatic Merkel cell carcinoma (mMCC) means that AstraZeneca (AZ) is playing catch-up with its rival durvalumab, which the regulator has under priority review in bladder cancer.
German Merck and Pfizer are now following in the footsteps of Bristol-Myers Squibb (BMS), Merck & Co, and Roche with their revolutionary cancer immunotherapies.
Bavencio, a human anti-PD-L1 antibody, the first approved therapy for mMCC, was approved under accelerated approval based on tumour response and duration of response data.
mMCC is a rare and aggressive skin cancer, with fewer than half of patients surviving more than a year and fewer than 20% surviving beyond five years.
Further confirmatory data will be necessary to maintain its approval in the US, where it will be co-marketed by EMD Serono, German Mercks US biopharma business, and Pfizer.
The drug was developed and approved quickly after the FDA granted the drug Breakthrough Therapy Designation and Priority Review status.
Pfizer and German Merck struck an alliance to develop avelumab back in 2014, with Pfizer paying $850 million up front, sweetening the deal with regulatory and commercial milestone payments worth around $2 billion.
Both companies jointly fund development and marketing costs and revenues from any anti-PD-L1 and anti-PD-1 products generated from the collaboration will be shared equally.
The deal envisages avelumab as a treatment for several types of cancer, both as a single agent, as well as in various combinations with Pfizer and Merck KGaAs approved or investigational oncology therapies.
Peak sales of Bavencio are predicted to be between $4 and $6 billion below the levels of BMS Opdivo, but a substantial chunk of money for two companies that are in need of new revenues as older drugs go off-patent.
The companies are chasing the valuable first-line lung cancer therapy that Mercks Keytruda (pembrolizumab) has been approved in, after the shock failure of BMS rival anti-PDL, Opdivo.
Roches anti-PD-L1 is powering ahead, most recently with an approval in second line lung cancer in patients with certain mutations.
Merck and Pfizer are developing Bavencio in a range of other uses, with several late-stage programmes under way, including the lucrative first-line lung cancer indication, gastric cancer, and ovarian cancer.
AZ is prioritising its durvalumab, a rival anti-PD-L1, as a combination therapy with its CTLA-4 checkpoint, tremelimumab.
AZ expects to file the combination in lung cancer indications, including the first-line lung cancer use, in the second half of this year.
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