(Roche) Feb 19, 2020 - Roche today announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq® (atezolizumab) as a first-line (initial) monotherapy for people with advanced non-squamous and squamous non-small cell lung cancer (NSCLC) without EGFR or ALK mutations with high PD-L1 expression (TC3/IC3 wild-type [WT]), as determined by PD-L1 biomarker testing. The FDA is expected to make a decision on approval by June 19, 2020.

H. Jack West, MD (Posted: February 19, 2020)

The results with atezolizumab in this highly enriched subset echo the findings with pembrolizumab in patients with tumor PD-L1 expression of 50% or higher in KEYNOTE-024, and again in KEYNOTE-042. Pembrolizumab is well established and FDA approved in this setting, and the 22c3 antibody for PD-L1 is the highly dominant standard molecular diagnostics test for PD-L1. The IMpower110 study shows very comparable benefit with atezolizumab in an even more selected subset of patients, using an antibody and testing method that is decidedly non-standard. I assume the FDA will approve single agent atezolizumab here, but there is no way in which atezolizumab monotherapy appears superior to the far more established standard of pembrolizumab in a broader but extremely similar population being tested with a far more widely used assay.

Read Article

(Five Prime) Feb 18, 2020 - Five Prime Therapeutics, Inc. today announced that Bristol-Myers Squibb informed the company that the randomized Phase 2 trial testing the combination of cabiralizumab with Opdivo® (nivolumab) with and without chemotherapy in patients with advanced pancreatic cancer did not meet its primary endpoint. While Bristol-Myers Squibb has no near term plans for additional sponsored development of cabiralizumab, Bristol-Myers Squibb will continue to support the evaluation of cabiralizumab in select, ongoing investigator-sponsored trials and may continue to assess future development opportunities for the investigational asset. Bristol-Myers Squibb also informed the company that no new safety signals were observed in the Phase 2 trial.

Howard S. Hochster, MD (Posted: February 18, 2020)

Another "swing and a miss" in pancreatic cancer. Despite numerous trial of chemotherapy plus targeted drugs, and now plus IO drugs, we have not seen a benefit. Cabiralizumab had more than the typical preclinical data (and hype) as it is an antibody to CSF1 on infiltrating lymphocytes and especially TAMs (Tumor Associated Macrophages) which are believed to be immunosuppressive. The antibody would block this kind of immunosuppression and allow anti-PD1 to work (like in melanoma!). Unfortunately this simple solution was not to be. So far finding effective IO approaches to pancreatic cancer still remains the "holy grail".

Read Article

(BioSpace) Feb 12, 2020 - A number of new medications stand a shot at early regulatory approval thanks to the U.S. Food and Drug Administration (FDA)’s priority review program. This week, the agency handed out a number of such designations, which will hasten potential approval.

William McGivney, PhD (Posted: February 17, 2020)

Every once in a while, in my columns, I mention that Rick Pazdur, MD of the FDA NEEDS to be recognized for how he has positively impacted the lives of thousands of patients with Cancer and their Caregivers. Dr. Pazdur has had remarkable success in speeding up FDA approvals for many, many drugs and biologics while at the same time maintaining a process that continues to assure assiduous evaluation of the safety and efficacy of these products. Dr. Pazdur deserves to be awarded the Presidential Medal of Freedom for what he has done in his own quiet way for the people of this country. While Yogi Berra and Chita Rivera were recognized for their contributions with the Presidential Medal, to me, saving and extending the lives of thousands of patients with cancer transcends what may recipients achieved or contributed. Dr. Anthony Fauci is a deserved winner for his tireless efforts to combat the AIDS epidemic and AIDS, the disease. I strongly believe that Dr. Pazdur has worked in the same sphere of achieving good as Dr. Fauci. I have had only had 2 very brief and casual conversations with Dr. Pazdur, so I am not looking to “get something for a close friend”, just for a highly deserving humanitarian. At the opening of the Yogi Berra Museum and Learning Center, Mr Berra said eloquently: “I’m lucky. Usually you’re dead to get your own museum, but I’m still alive to see mine”. It is past time for Dr. Pazdur to receive the recognition and Thanks that he so richly deserves. I have spoken with national cancer provider organizations that agree with my proposal. Let’s work to get this done!

Read Article