OBR Daily Commentary

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Roche Takes Tecentriq Hit On Survival Data

(Reuters) July 19, 2018 - Roche’s hopes of clinching more of the lung cancer treatment market with its Tecentriq immunotherapy had a major setback on Thursday, when a trial failed to deliver survival data the Swiss drugmaker needs to challenge rival Merck. Tecentriq, mixed with chemotherapy, has not yet achieved a hoped-for overall survival target in first-line non small cell lung cancer treatment, the Swiss drugmaker said on Thursday, though the cocktail did reduce risks of the disease worsening. Overall survival is the gold standard for judging a medicine’s effectiveness, but Roche now must wait until at least next year to show Tecentriq plays a significant role in keeping patients alive.

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H. Jack West, MD (Posted: July 19, 2018)

quotesOn balance, these data for advanced non-squamous NSCLC compare unfavorably to those of the very similarly designed KEYNOTE-189, another platinum/pemetrexed +/- immunotherapy trial (with placebo on control arm), with IMpower132 showing a significant PFS benefit but failing to demonstrate an OS benefit. This pattern strongly echoes what we saw with IMpower131 vs. KEYNOTE-407 in the setting of advanced squamous NSCLC. Taken together, pembrolizumab and Merck clearly have the upper hand here, and we would interpret that pembrolizumab is a more efficacious agent. However, I hope to delve more into the practical issue of the actual crossover rates of these two trials to clarify whether a higher crossover on the IMpower trials may contribute to the absence of a significant OS difference. In KEYNOTE-407 and KEYNOTE-189, for instance, crossover was permitted but was still only in the range of 43-50% of eligible patients. If only half of the patients on the chemo only arms of these KEYNOTE trials ever received effective immunotherapy at any point, but a clear majority of the patients on the chemo arms of the IMpower trials received immunotherapy on crossover, it could explain how pembro appears to be conferring a survival benefit not seen with atezolizumab. If no real difference in the crossover rates, then the nod simply needs to go to pembrolizumab for greater efficacy. Regardless, I fear that even if it turns out that crossover rates explain the OS difference more than true drug efficacy, the world may end up failing to care about such details, and rather just punishing Roche for running trials in a way that is better for the participating patients but that undermines their ability to report an OS benefit.quotes

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How An Old Diabetes Drug Made A Big Splash At The Biggest Cancer Confab

(Forbes) June 7, 2018 - At the recently concluded annual meeting of the American Society of Clinical Oncology (ASCO) a group of researchers from Mexico City described a surprising discovery: In a phase 2 trial in patients with stage 4 lung cancer, a 24-year-old diabetes drug significantly improved survival when added to a standard therapy.

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

quotesThis work is certainly provocative, but there are several issues that should lead us to be cautious about concluding that this should change practice. Not only was this not a large trial, but the patients in the control arm who received erlotinib alone demonstrated a response rate that was remarkably low for EGFR mutation-positive cancer, about half of what is more commonly seen. There have also been other trials that have been far less impressive but not publicized. Overall, it merits further study but needs validation before being considered a combination approach to pursue outside of an investigational strategy.quotes

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Phase III IMpower130 Study Showed Roche’s Tecentriq (Atezolizumab) Plus Chemotherapy (Carboplatin And Abraxane) Helped People With Metastatic Non-squamous NSCLC Live Significantly Longer Compared To Chemotherapy Alone

(Roche) May 29, 2018 - Roche today announced that the Phase III IMpower130 study met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS).

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H. Jack West, MD (Posted: May 29, 2018)

quotesImportant trial result, positive for both PFS & OS benefit, that confirms benefit of first line chemo-immunotherapy, here with atezolizumab added to carbo/nab-paclitaxel in patients with advanced non-squamous NSCLC, is not specific to a particular chemo backbone or immune checkpoint inhibitor. Instead, it's looking more and more like relatively comparable results will be seen in multiple trials, and we'll have a choice of chemo doublets paired with checkpoint inhibitors. In that setting, people will gravitate to the chemo regimens they prefer in this setting, and in the US, I think carbo/pemetrexed will be favored for most patients with advanced non-squamous NSCLC. I think with KEYNOTE-021g regimen of carbo/pemetrexed/pembro already FDA approved and KEYNOTE-189 looking so impressive, this will be the default regimen. This means that any new chemo/immunotherapy combination will be reviewed in the context of whether it provides a meaningful incremental benefit over carbo/pem/pembro. I don't think carbo/nab-paclitaxel/atezolizumab can be said to be anything more than a lateral move at best. The only real caveat I'd offer is the possibility that the story of steroid treatment with chemo/immunotherapy or immunotherapy alone may detract from the benefit of immunotherapy, which some retrospective work has indicated, though the 3 days of premedication with pemetrexed likely wouldn't register as enough to undermine the benefit of immunotherapy, and certainly the highly positive results of the KEYNOTE-189 trial argue against that.quotes

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Meet the Editorial Board

Prostate Cancer
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Tomasz M. Beer, MD, FACP

Professor of Medicine, Division of Hematology/Medical O...

Community Oncology
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Dean Gesme, MD

FACP FACPE FASCO President, Minnesota Oncology...

Breast Cancer
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Debu Tripathy, MD

Professor and Chair, Department of Breast Medical Oncol...

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H. Jack West, MD

Medical Director, Thoracic Oncology Program, Swedish Ca...

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Howard S. Hochster, MD

Distinguished Professor of Medicine, Rutgers Robert Woo...

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