|Merck KGaA healthcare chief Belén Garijo|
Partners Merck KGaA and Pfizer ($PFE) are looking to prove their 5th-place immuno-oncology treatment can contend with the leaders in the field, launching a late-stage lung cancer study to establish the antibody's promise.
The two companies are now enrolling previously untreated patients with non-small cell lung cancer (NSCLC) in order to compare their treatment, avelumab, against standard chemotherapy. The plan is to find about 420 patients from around the world, running the study in tandem with a second Phase III trial testing avelumab in patients whose NSCLC has endured chemotherapy.
Merck KGaA and Pfizer's treatment is a so-called checkpoint inhibitor, targeting a protein called PD-L1 to unblind the immune system and galvanize an attack on cancer. Merck ($MRK) and Bristol-Myers Squibb ($BMY) lead the checkpoint pack with a pair of immunotherapies already approved for melanoma and NSCLC. Just behind them are Roche ($RHHBY), which is soon to file its PD-L1-targeting atezolizumab for global approvals, and AstraZeneca ($AZN), which is on the same path with its Phase III durvalumab.
Pfizer bought into the Merck KGaA-invented avelumab, formerly MSB0010718C, in a nearly $3 billion deal last year, and the partners have since vowed to catch up to their more advanced rivals by homing in on underserved cancers. They've identified the rare Merkel cell carcinoma, or MCC, as an ideal initial target and are moving forward in that disease with the FDA's fast-track designation.
Avelumab is unlikely to be in line for global approval until 2017 at the earliest, but Merck KGaA healthcare chief Belén Garijo has said the antibody could be among the first checkpoint blockers approved for MCC as well as ovarian, gastric, bladder and renal cancers.
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