Germany’s Merck on Wednesday reported encouraging interim data against a rare and aggressive form of skin cancer from a midstage trial of its experimental drug that helps the immune system attack tumours.
In the 61-patient study, about 30% of those with Merkel skin cell carcinoma treated with Merck’s avelumab saw their tumours shrink or disappear.
Avelumab, which German Merck is developing with Pfizer, belongs to a class of drugs called PD-L1 inhibitors that block a mechanism tumours use to hide from the immune system, allowing it to recognise and attack the cancer. They are closely related to the PD-1 drugs already on the market from Bristol-Myers Squibb (Opdivo) and Merck & Co (Keytruda) seen as major advances against melanoma, lung cancer and other malignancies.
Roche’s Tecentriq earlier on Wednesday became the first approved PD-L1 drug, gaining US approval to treat advanced bladder cancer.
Patients in the avelumab skin cancer study had not been helped by previous treatment with standard chemotherapy, leaving them without further treatment options, known as second-line therapy.
“As there are no approved treatments for second-line metastatic Merkel cell carcinoma and the standard of care is participating in clinical trials, these data represent a potential breakthrough for these patients,” said Luciano Rossetti, head of research for Merck’s biopharma business.
The drug was not tested against another medicine or placebo.
But researchers concluded from an interim analysis that avelumab demonstrated “a manageable safety profile with durable responses”.
Six patients, or about 10%, experienced complete responses with no signs of cancer, while 12 others saw significant tumour shrinkage.
The data will be presented at the American Society of Clinical Oncology meeting in Chicago in June, and could be used as a basis for seeking US approval.
The US Food and Drug Administration awarded avelumab its breakthrough designation, which is given to drugs seen as a potentially important advance for specific diseases and can speed up the approval process.
For Merck, which also makes chemicals for display screens and lab supplies, avelumab could help to revive its fortunes in pharmaceuticals after a string of setbacks. For Pfizer, seen as lagging the leaders in the immuno-oncology field, avelumab could be its first significant entry.
The drug is also being tested against lung, breast, gastric and ovarian cancers, and in combination with other medicines.
Source: Business Day Live