- Merck KGaA and Pfizer have posted positive interim results on avelumab, their PD-L1 drug in development for treatment of Merkel cell carcinoma (MCC), a rare skin cancer with a 20% five-year survival rate.
- MCC is not only rare and deadly, but difficult to treat. The current standard of care is chemotherapy and surgery. There are no second-line treatment options.
- This candidate is the result of an $850 million agreement initiated between Merck KGaA and Pfizer in 2014. This deal involves testing Merck KGaA's pipeline of checkpoint inhibitors to develop potential candidates. Other drugs from Pfizer's oncology pipeline are also being tested as part of various combinations.
In the era of immuno-oncology and the cancer moonshot, collaboration and combination therapy are the two mantras of oncology drug development. And now that Roche's Tecentriq (atezolizumab) has joined the approved checkpoint inhibitors (for treatment of bladder cancer), the sense of momentum among this class of oncologics is increasing.
Enter the Merck KGaA/Pfizer team with avelumumb. In an interim study of avelumumab for MCC, 61 patients were tested. Of those patients, six (10%) had complete remission with no evidence of tumor, while 12 patients saw significant tumor shrinkage.
While this study was not placebo-controlled, and not powered to show significance, it shows efficacy in second-line treatment of MCC in a category where options are slim. Given the preliminary results, combination therapy in a larger, randomized, placebo-controlled trial could position this candidate for fast-tracking.