OBR Daily Commentary

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Imfinzi Significantly Improves Overall Survival In The Phase III PACIFIC Trial For Unresectable Stage III Non-small Cell Lung Cancer

(AstraZeneca) May 25, 2018 - Imfinzi met the second primary endpoint of overall survival which was both statistically-significant and clinically-meaningful at a planned interim analysis.

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H. Jack West, MD (Posted: May 25, 2018)

quotesThis finding of a significant OS result was as I would have expected -- with the profound and sustained PFS benefit going out to at least 18 months, as well as a significant benefit with consolidation durvalumab in time to new metastatic disease or death, it was nearly inconceivable that there wouldn't be a significant improvement in OS. What remains to be seen, however, is whether this will be a sustained OS benefit that actually raises the tail of the curve and leads to more patients alive and without disease at 3 and 4 and more years, or whether the year of durvalumab is just delaying the relapse that would otherwise occur in the same proportion of people. In other words, can immunotherapy eradicate the residual disease in people who would otherwise be destined to relapse and die of their cancer, leading to more cures, or is it merely suppressing the disease that will still lead to relapse, just now with enough of a time delay to lead to a transient improvement in survival. We await not only the data leading to this press release, but also the more longitudinal results of this important trial.quotes

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Merck's Keytruda Succeeds In Late-Stage Lung Cancer Study

(Reuters) May 23, 2018 - Merck & Co on Wednesday said its cancer drug Keytruda helped extend survival and prevented disease progression when tested in a late-stage study in combination with chemotherapy for a type of lung cancer.

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H. Jack West, MD (Posted: May 24, 2018)

quotesKEYNOTE-407 was already #2 on my top 5 abstracts in lung cancer for ASCO 2018, behind only the KEYNOTE-042 Plenary Session presentation, but this latest press release now makes it rival KN-042 in significance. With the new results of a significant PFS and OS benefit on top of the already reported 23% higher objective response rate noted in the abstract, we should expect that this will lead to a timely approval of this combination of carbo/nab-paclitaxel/pembrolizumab for first line treatment of advanced squamous NSCLC, regardless of tumor PD-L1 expression level. The landscape is likely to mirror that for non-squamous NSCLC, where a chemo/immunotherapy combination (carbo/pemetrexed/pembro) is approved regardless of PD-L1 expression, while the leading alternative is pembro monotherapy for patients with high PD-L1 based on KEYNOTE-024, or soon even for those with PD-L1 1% or higher, based on KEYNOTE-042. So in both squamous and non-squamous NSCLC, it's very likely the leading alternatives will be pembro monotherapy vs. chemo/pembro for those with tumors positive for PD-L1, and chemo/pembro for those whose tumors are PD-L1 negative. IMpower131 will also feature some positive results with carbo/nab-paclitaxel/ataezolizumab, but thus far we know only about a significant PFS benefit. Not only will it need to show a significant OS benefit to compete at all with KEYNOTE-407 results, it will be up against a pembro juggernaut, with multiple positive trials and an increasingly powerful narrative of benefit in many NSCLC trials.quotes

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Roche Immunotherapy Combination Increases Lung Cancer Survival - Study

(Reuters) May 16, 2018 - Roche’s immunotherapy Tecentriq, given with its older drug Avastin and chemotherapy, improved survival of advanced lung cancer patients by about 30 percent over the combination without Tecentriq, according to interim results of a late stage trial released on Wednesday.

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H. Jack West, MD (Posted: May 17, 2018)

quotesIt looks like we're going to have data from the IMpower150 trial released in small bits every few months, without any new electrifying developments. Here, the most notable finding is the hazard ratio for OS of 0.54 among patients with an EGFR mutation or ALK rearrangement who received carbo/paclitaxel/bevacizumab + atezolizumab, compared to carbo/pac/bev alone. Patients with liver mets also had the same HR for OS of 0.54 with chemo/bev/atezo. The reality is that the real comparator for the IMpower150 four-drug regimen is carbo/pemetrexed/pembro (as per KEYNOTE-189), and I think for a broad population, the KEYNOTE-189 regimen is more compelling. However, for patients with an EGFR mutation especially, and to a lesser extent those with an ALK rearrangement, the carbo/pac/bev/atezo regimen deserves to be considered as a compelling option AFTER patients have progressed on initial targeted therapy. Importantly, these patients were to have already received an EGFR or ALK TKI, and the IMpower150 approach should not replace highly effective targeted therapy as first line treatment. We should expect to see far more work on immunotherapy in patients with a driver mutation. One of the most significant effects of IMpower150 will be that it leads to a re-opening of this question, after the data we had in 2nd line NSCLC led most lung cancer specialists to conclude that checkpoint inhibitors don't have meaningful activity in these patients. Finally, we need to clarify if the benefit requires bevacizumab, which can be answered by seeing how Arm A of IMpower150 (carbo/pac/atezo, no bev) does. That hasn't been reported yet but can help us understand the contribution of the bev component on Arm B.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...

Lung Cancer
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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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Ronald H. Bloom Chair in Cancer Therapeutics
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Robert A. Figlin, MD., FACP

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National Health Policy Expert...

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