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FDA Grants Priority Review to Genentech’s Cancer Immunotherapy TECENTRIQ (Atezolizumab) for Initial Treatment of People With a Specific Type of Metastatic Lung Cancer

(Genentech) May 6, 2018 - Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for TECENTRIQ® (atezolizumab), in combination with Avastin® (bevacizumab), paclitaxel and carboplatin (chemotherapy), for the initial (first-line) treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC).

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H. Jack West, MD (Posted: May 07, 2018)

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Though reportedly leading to a statistically significant improvement in overall survival in the IMpower150 trial (per a press release, data yet to be revealed), the carbo/paclitaxel/bevacizumab/atezolizumab combination adds little other than neuropathy and hair loss to the regimen of carbo/pemetrexed/pembrolizumab already approved by the FDA in advanced non-squamous NSCLC. The one finding that was novel and striking about the IMpower150 trial data thus far is that the 14% of patients enrolled who had an EGFR mutation or ALK rearrangement and had progressed on prior targeted therapy demonstrated a relative improvement in PFS with addition of atezolizumab that was every bit as good as that seen in the broader population. In fact, patients with an activating EGFR mutation had a HR for PFS with carbo/pac/bev/atezo of 0.41 relative to carbo/pac/bev alone. This should lead to far greater enthusiasm for using immunotherapy combinations for patients with a driver mutation after they have developed acquired resistance. However, it remains to be seen whether people will favor this particular regimen or possibly extrapolate that this benefit will also be conferred by pembrolizumab added to carbo/pemetrexed.

I think the most important thing the IMpower150 trial will end up doing is changing our perspective on the role of immunotherapy in patients with a driver mutation. We have much more to learn about this question.

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