Today's question for Dr. Hamid is:
What is the recent data with PD-1 therapy with melanoma and other solid tumors?
Dr. Hamid: That’s a wonderful question. Recently, if you picked up a paper or logged into your favorite website and found that there has recently been an approval of a PD-1 checkpoint inhibitor named “Pembrolizumab” for patients with metastatic melanoma.
This was based on benefits seen in a Phase I/II study showing a significant response rate and a durability of response. This is the first checkpoint inhibitor approved in the United States, but not the first checkpoint inhibitor approved worldwide. Nivolumab made by Bristol-Myers was approved in Japan recently.
These checkpoint inhibitors – these PD-1 and PDL-1 inhibitor therapies – are starting to show response in multiple solid tumors. If you look in on ASCO 2014, you recognize that the FDA has clearly indicated that the MPDL3280 – the PDL-1 antibody made by Genentech – is a breakthrough therapy and is being evaluated for patients with metastatic bladder cancer in the second line. This is an indication that has had no clear cancers and our recent Phase I data has shown a 50% response rate in these patients.
Also, if you checked in at ASCO 2014 you realize that the Bristol drug has been indicated as breakthrough for lymphoma. There was amazing data presented in multiple solid tumors, including head and neck cancer, lung cancer, ovarian and renal cell carcinoma. These data are starting to mature and they are randomized. Phase III trials are either accrued or near completion of accrual. So, I expect the next year to two to be a tour de force presentation of these data and hopefully options for patients with multiple solid tumors to benefit.
In our clinic today – at The Angeles Clinic and Research Institute – we are accruing to trials for patients with cervical cancer, merkel cell carcinoma, HPV positive tumors, nasopharyngeal carcinomas, even glioblastama multiforme, and prostate cancer. Now, what’s come of this is the understanding that the immune system is integral in our eradication of multiple solid tumors. Data presented in world lung and ESMO Conference have shown significant response rates in heavily pre-treated lung cancers with good durability of response. This is all being born out in major Phase II and Phase III trials.
So, we have had some inroads of data that will be presented at future meetings, including our upcoming meeting at Antibody Engineering and Therapeutics. It will hopefully elucidate the future role of checkpoint inhibitors and PD-1s in the future.
Dr. Hamid will be presenting The Promise of PD1 Checkpoint Inhibition for Multiple Solid Tumors on Wednesday, December 10 at the Antibody Engineering and Therapeutics event. For more information on his session and the rest of the program, download the agenda. As a reader of this blog, when you register to join us and mention code XD14172BLOGJP, you can save 20% off the standard rate.
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