Pfizer Inc. PFE and Merck KGaA MKGAF announced the initiation of two multi-center, randomized, open-label phase III studies – JAVELIN Gastric 100 and JAVELIN Gastric 300 – on their experimental anti-PD-L1 IgG1 monoclonal antibody avelumab, for the treatment of patients suffering from advanced or metastatic gastric/gastro-esophageal junction (GEJ) cancers.
The JAVELIN Gastric 100 study will evaluate the superiority of avelumab immunotherapy as a first-line maintenance treatment of patients with unresectable, locally advanced or metastatic gastric/GEJ cancers whose disease has not progressed with first-line platinum-based chemotherapy.
On the other hand, the JAVELIN Gastric 300 study will assess the superiority of avelumab immunotherapy for the third-line treatment of patients with unresectable, recurrent or metastatic gastric/GEJ cancers, compared with investigator’s choice of chemotherapy from a pre-specified list of therapeutic options.
The primary endpoint of both studies on avelumab – in the first-line and third-line settings – is overall survival. This is the third and fourth respective phase III studies on avelumab to be initiated by Pfizer and Merck KGaA in 2015. We note that the companies initiated a couple of phase III studies on avelumab for the treatment of non-small cell lung cancer (NSCLC) this year.
We are encouraged by the companies’ progress with avelumab. Per information provided in their press release, gastric cancer/GEJ cancers are aggressive cancers with poor survival rates.
We remind investors that in Nov 2014, Pfizer and Merck KGaA had announced a strategic alliance to co-develop and co-commercialize avelumab. The companies intend to commercially launch avelumab in 2017, provided the candidate is successfully developed and approved. Thereafter, they are targeting at least one additional potential launch per year through 2022.
Currently, avelumab is being developed for more than 15 types of tumors including breast cancer, gastric/GEJ cancers, head and neck cancer, Merkel cell carcinoma (MCC), melanoma, mesothelioma, NSCLC, ovarian cancer, renal cell carcinoma and urothelial (e.g. bladder) cancer. Avelumab enjoys Orphan Drug, Breakthrough Therapy and Fast Track status in the U.S. for the treatment of MCC.
Pfizer is a Zacks Rank #2 (Buy) stock. A couple of favorably ranked stocks in the health care sector are Achillion Pharmaceuticals, Inc. ACHN and Anika Therapeutics Inc. ANIK. Both carry a Zacks Rank #1 (Strong Buy).
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