(Morningstar/Dow Jones Newswires) Dec 6, 2018 - Genentech, a member of the Roche Group, on Thursday said the U.S. Food and Drug Administration approved Tecentriq and chemotherapy for some patients with a certain type of lung cancer. Genentech said the FDA gave its approval to Tecentriq in combination with Avastin, paclitaxel and carboplatin for the first-line treatment of patients with metastatic non-squamous non-small cell lung cancer, with no EGFR or ALK genomic tumor aberrations.

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

While it's nice to have a new approval, this is also a setting in which the IMpower150 regimen offers nothing beyond what we already have with the KEYNOTE-189 trial regimen of platinum/pemetrexed/pembrolizumab, except alopecia and neuropathy risk. The only real setting in which there is an unmet need now is for those patients with an EGFR mutation or ALK rearrangement who have received and progressed on a prior tyrosine kinase inhibitor -- these patients have been excluded from nearly all of the trials for chemotherapy +/- immunotherapy, but the carbo/paclitaxel/bev/atezo arm was associated with a PFS and OS benefit in EGFR mutation-positive patients at least as strong with addition of atezo to carbo/pac/bev as was seen in the broader population (not as clear that this can be said for ALK-positive patients). Unfortunately, the FDA approval specifically excludes patients with an EGFR mutation or ALK rearrangement, so I anticipate that this approval will (and should) have minimal impact on practice patterns, and we are left with no clear direction on how to approach patients with acquired resistance and EGFR mutation-positive NSCLC.

(Reuters) Dec 5, 2018 - Swiss group Roche Holding AG said on Wednesday its Tecentriq immunotherapy mixed with chemotherapy won priority review from the U.S. regulator for treating a type of lung cancer, a potential boost to the drug that has been trailing rivals’ revenues. The announcement comes after Roche in September said patients with untreated extensive-stage small cell lung cancer (SCLC) lived a median 12.3 months after getting the Tecentriq cocktail, compared to 10.3 months for those getting chemotherapy alone. Winning the speedy review from the U.S. Food and Drug Administration sets up possible U.S. approval for Tecentriq in this indication by March 18, the drugmaker said in a statement.

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H. Jack West, MD (Posted: December 05, 2018)

This will be an important development for thoracic oncology. The results of the IMpower133 trial, which demonstrated a significant survival benefit with the addition of atezolizumab to standard carbo/etoposide chemo as first line treatment for extensive stage small cell lung cancer (SCLC), were not astonishingly better than chemo, but they are enough that they should change the standard of care. Significant improvements in overall survival, even if not overwhelming, are infrequent enough in oncology in general and SCLC specifically, that we should be eager to adopt them when available. Having this regimen approved will make it far easier to pursue this combination broadly as a new standard of care.

(BMS) Nov 26, 2018 - Bristol-Myers Squibb Company today announced that the Phase 3 CheckMate -451 study did not meet its primary endpoint of overall survival (OS) with Opdivo (nivolumab) 1 mg/kg in combination with Yervoy (ipilimumab) 3 mg/kg versus placebo as a maintenance therapy for patients with extensive-stage small cell lung cancer (SCLC) without disease progression after completion of first-line platinum-based chemotherapy. No new safety signals were observed with Opdivo 1 mg/kg plus Yervoy 3 mg/kg in this study. The Company will work with study investigators on the future publication of these results. CheckMate -451 is a global, double-blind, randomized Phase 3 study evaluating Opdivo in combination with Yervoy and Opdivo monotherapy versus placebo as a maintenance therapy in patients with extensive-stage small cell lung cancer without disease progression after completion of first-line platinum-based chemotherapy. The primary endpoint of the study is overall survival (OS) with Opdivo plus Yervoy versus placebo. The secondary endpoint is OS with Opdivo monotherapy versus placebo.

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H. Jack West, MD (Posted: November 27, 2018)

This is a big miss. Though even a positive result would need to be weighed for significance relative to the positive results for chemo/atezolizumab in the first line IMpower133 trial, the fact that this trial failed to improve survival compared to placebo in the maintenance setting is a great disappointment, especially on top of the recently reported (though only as a press release thus far) negative result on the CheckMate-331 trial of nivolumab alone vs. 2nd line chemo for relapsed SCLC. This result leads me to be far less inclined to consider either nivo or nivo/ipi as a very compelling option in relapsed SCLC, despite the FDA approval of nivo in this setting (actually 3rd line) earlier this year, or based on the Checkmate-032 phase II trial, which seems in retrospect to be yet another reminder of the power of selection bias. Should the emerging results also cloud our view on the utility of nivolumab +/- ipilimumab in NSCLC? Not enough to counter strong data, but we don't have particularly strong data in first line NSCLC at this time. These negative results on CheckMate-451 also do not challenge the current concept of integrating immunotherapy into first line treatment for SCLC rather than deferring it as maintenance or 2nd line treatment. Though some are disappointed by the only relatively modestly positive results of IMpower133 with carbo/etoposide +/- atezolizumab, the significant improvement in OS should be sufficient to consider this approach the current standard of care for eligible patients. And the recent results with nivo +/- ipi in SCLC only underscore that significant gains in survival for patients with SCLC are quite hard to come by.