FDA grants Fast Track Designation to seribantumab (MM-121) in NSCLC

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print

FDA granted seribantumab, also known as MM-121, a Fast Track designation for development in patients with heregulin-positive, locally advanced or metastatic non-small cell lung cancer, whose disease has progressed following immunotherapy.

Merrimack Pharmaceuticals, the drug’s sponsor, is conducting the SHERLOC trial, a global clinical study of seribantumab in combination with docetaxel or pemetrexed in heregulin-positive patients with NSCLC that is designed to support a Biologics License Application to the FDA. Seribantumab is Merrimack’s wholly owned, fully human monoclonal antibody that targets ErbB3.

“Heregulin-positive cancer cells are characterized by their ability to escape the effects of a broad range of cancer therapies and potentially contribute to accelerated disease progression. The SHERLOC trial is designed to advance the development of a much-needed treatment option for patients with heregulin-positive NSCLC after they progress on immunotherapies. This is important because we find that more than 50% of patients with NSCLC are heregulin-positive,” said Akos Czibere, vice president of clinical development at Merrimack.

SHERLOC is an open-label, multi-center, phase II study. Merrimack expects to enroll approximately 280 heregulin-positive patients who will be randomized to receive seribantumab in combination with either docetaxel or pemetrexed versus docetaxel or pemetrexed alone. Patients will be screened for heregulin status using a fully validated RNA-ISH assay. Eligible patients for the study must have failed prior treatment with no more than three lines of therapy including prior anti-PD-1 or anti-PD-L1 immunotherapy. The study’s primary endpoint is overall survival with secondary endpoints including progression free survival, objective response rate, and safety and quality of life measures.

YOU MAY BE INTERESTED IN

Pfizer External Research & Grants’ “Improving Breast Cancer Quality of Care via Meaningful Capacity Building in Sub-Saharan Africa,” powered by EveryGrant, has announced grants totaling more than $900,000 for addressing inequities and improving the quality of breast cancer care in Sub-Saharan Africa.
It started innocuously enough. I looked in the mirror and noticed a pigmented area on my scalp just into the hairline. Like many patients, thoughts started running through my head: “Maybe it’s nothing.” Looking at my Outlook calendar, it was packed morning-to-night with meetings, patients, and travel, so I decided I would get that spot checked out the minute I had “time.” 

In the morning of May 28, presumably before turning off the lights and closing the office door, someone at the now defunct NCI Office of Communications and Public Liaision decided to post a farewell message to the cancer community.  The message, posted on multiple social media accounts, read: We’re taking a pause here - but...

Never miss an issue!

Get alerts for our award-winning coverage in your inbox.

Login