OBR Daily Commentary - Lung (includes NSCLC, SCLC, Mesothelioma)

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Second-Line Nivolumab Is Not Superior to Chemotherapy in SCLC

(ESMO I-O Congress) Dec 13, 2018 - Treatment with the anti-PD1 antibody, nivolumab, did not improve response rates or survival over standard chemotherapy in patients with metastatic small-cell lung cancer (SCLC) who relapsed following first-line treatment, according to findings presented at the ESMO Immuno-Oncology Congress 2018 in Geneva, Switzerland. Martin Reck of the Lung Clinic Grosshansdorf, German Centre of Lung Research in Grosshansdorf, Germany noted that, although patients with SCLC often show high initial response rates, most patients will relapse soon after first-line treatment. These relapsing patients have few treatment options leaving them with a poor prognosis. Professor Reck and colleagues conducted the CheckMate 331 (NCT02481830) study evaluating nivolumab, which has been approved in the USA for treatment of patients with SCLC and progression after platinum-based chemotherapy and one or more other lines of treatment.

H. Jack West, MD (Posted: December 14, 2018)

quotesThough the authors and proponents from BMS highlight that the handful of patients who responded to nivo had a longer response rate than was seen with chemo, that's damning with faint praise for a therapy that will cost what nivo does. The vast majority of patients getting nivo for relapsed SCLC don't benefit.quotes

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Imfinzi Demonstrates Clinical Activity In Stage IV, 1st-Line Non-Small Cell Lung Cancer In Phase III MYSTIC Trial

(BioSpace) Dec 13, 2018 - AstraZeneca and MedImmune, its global biologics research and development arm, have presented overall survival (OS) and progression-free survival (PFS) data from the Phase III MYSTIC trial at the European Society for Medical Oncology (ESMO) Immuno-Oncology 2018 Congress in Geneva, Switzerland. The MYSTIC trial evaluated Imfinzi (durvalumab) monotherapy and the combination of Imfinzi plus tremelimumab, an anti-CTLA4 antibody, versus standard-of-care (SoC) platinum-based chemotherapy in previously-untreated patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC).1 Results show that Imfinzi monotherapy demonstrated clinical activity with an OS hazard ratio (HR) of 0.76 (97.54% CI 0.564-1.019; nominal p=0.036) in the primary analysis population of patients whose tumours express PD-L1 on 25% or more of their cancer cells, but this result did not meet statistical significance.

H. Jack West, MD (Posted: December 14, 2018)

quotesThese data on MYSTIC stave off the executioner for durva or durva/treme in first line treatment of stage IV NSCLC, but I don't think they are favorable enough to call them highly encouraging. The reality today is that the true comparator is no longer doublet chemo alone but chemo with pembrolizumab, with decidedly better outcomes than chemo alone. In this setting, it's hard to conclude that durvalumab measures up even as a lateral move. And while the TMB gambit provides a post-hoc escape hatch for a growing number of trials that fail on their original prospective design, these results for high TMB patients need not only to be replicated in a prospectively designed trial but need to prove superior to a general approach of chemo/pembro for the PD-L1 0-49% expression population, or pembro monotherapy perhaps for the high PD-L1 subgroup, to reach a tipping point of clear clinical relevance.quotes

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Genentech: FDA Approves Tecentriq in Combination for Some Lung Cancer Patients

(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.

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

quotesWhile 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.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...

Gastrointestinal Cancers
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Howard S. Hochster, MD

Distinguished Professor of Medicine, Rutgers Robert Woo...

Radiation Oncology
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Howard Sandler, MD, MS, FASTRO

Ronald H. Bloom Chair in Cancer Therapeutics
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Chief Medical Officer and Founder, N-of-One...

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Michael G. King Jr.

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Richard Goldberg, MD

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Robert A. Figlin, MD., FACP

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Florida Cancer Specialists President and Managing Part...

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National Health Policy Expert...

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