Merck KGaA/Pfizer Avelumab In JAVELIN Ovarian 100 Study

Merck (NYSE:MRK) KGaA MKGAF and its partner Pfizer Inc. (NYSE:PFE) announced that they have initiated a phase III study – JAVELIN Ovarian 100 – on avelumab, in combination with platinum-based chemotherapy, for the treatment of patients with locally advanced or metastatic disease with previously untreated epithelial ovarian cancer.

The study will evaluate the safety and efficacy of avelumab in treatment-naïve patients with locally advanced or metastatic ovarian cancer (Stage III or Stage IV). This is the first late-stage study evaluating the addition of an immune checkpoint inhibitor to the standard-of-care treatment for such an aggressive form of cancer.

In Dec 2015, the two companies had initiated the phase III JAVELIN Ovarian 200 study to assess the superiority of avelumab as monotherapy or in combination with pegylated liposomal doxorubicin (PLD), compared with PLD alone, for the treatment of patients with platinum-resistant/refractory ovarian cancer.

We note that in Nov 2014, Merck KGaA had entered into a strategic collaboration with Pfizer to co-develop and co-commercialize avelumab. Currently, avelumab is being developed for more than 15 types of tumors including breast cancer, gastric/gastro-esophageal junction cancers, head and neck cancer, melanoma, Merkel cell carcinoma, non-small cell lung cancer, ovarian cancer, renal cell carcinoma and urothelial (e.g. bladder) cancer.

The companies intend to commercially launch avelumab in 2017, assuming successful development and a subsequent approval of the candidate. Thereafter, they aim to make at least one additional launch every year through 2022.

According to the International Agency for Research on Cancer of the World Health Organization, nearly a quarter of a million women are diagnosed with ovarian cancer worldwide each year.

The ovarian cancer space is currently crowded by drugs including Lynparza, Doxil, Paraplatin and Avastin among others.

Investors looking for top-ranked stocks in the health care sector may consider GW Pharmaceuticals plc (NASDAQ:GWPH) and United Therapeutics Corp. (NASDAQ:UTHR) . Both these stocks sport a Zacks Rank #1 (Strong Buy).

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