Merck is launching an expanded access program for their anti-PD1 drug lambrolizumab. Clinical trials have shown very positive results for this drug, with response rates significantly higher than any drug currently approved for melanoma.
Here are the key points:
· The program will initially be available at sites in the United States that have been involved in the Merck PD-1 trials. Fairly quickly it will be made available to other physicians in the US who have experience treating melanoma with immunotherapy. After that, the expansion will extend globally.
· It is open to all patients with advanced melanoma, with no exclusion for ocular, mucosal, or acral melanoma.
· Patients with brain mets are allowed if the brain mets have been treated. The mets do not have to be resolved, but some treatment must have been given.
· Patients in previous Merck PD-1 trials are not eligible. This includes patients who have been in the head-to-head study of Merck’s PD-1 drug vs. ipilimumab.
This is just being announced to clinicians and I don't believe it is live yet on Clinicaltrials.gov. That should happen within the next few hours and will include a number doctors can call to get more information.
Here is the process: The doctor will hear about and enroll in the program. The clinician's Institutional Review Board (IRB) will need to approve the program; generally 2 to 3 days. Then patients can start being evaluated for eligibility.
This is great news for melanoma patients, particularly since a lot of PD-1 trials are currently closed.