(AstraZeneca) Aug 21, 2019 - AstraZeneca today announced final overall survival (OS) results from the Phase III NEPTUNE trial, a randomised, open-label, multi-centre, global trial of Imfinzi (durvalumab) in combination with tremelimumab, an anti-CTLA4 antibody, vs. standard-of-care (SoC) platinum-based chemotherapy in previously-untreated Stage IV (metastatic) non-small cell lung cancer (NSCLC) patients. The trial was performed in an all-comers population, and the primary analysis population was patients with a high tumour mutational burden (TMB). TMB is a measurement of the number of mutations within the genome (DNA) of a tumour, and tumours with high levels of TMB may be more visible to the immune system.1,2

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H. Jack West, MD (Posted: August 21, 2019)

Disappointing but not surprising. Despite the recent press release about CheckMate 227 results showing nivo/ipi beating chemo alone in first line NSCLC, the combination doesn't come close to deserving to displace the chemo/pembro combinations or pembro monotherapy that have handily beaten chemo already and are the current standards of care. And nivo/ipi has at least had some positive traction, while durva/treme has failed in every lung cancer setting in which it has been studied. The durva/treme regimen deserves to be relegated to "asked and answered" status in lung cancer research. It has failed every way it can. In the process, it has only dampened enthusiasm for the concept of IO combinations and the potential benefit of TMB in clinical decision making, concepts that are on the cusp of being integrated at least into the margins of practice but are more questionable with the release of these findings.

(Yahoo! Finance) Aug 19, 2019 - New Drug Application (NDA) for lurbinectedin for second-line treatment of small cell lung cancer (SCLC) will be submitted under accelerated approval regulations pursuant to discussion with FDA. The filing, anticipated in the fourth quarter of 2019, will be based on data from the Phase II basket trial. The lurbinectedin monotherapy trial in SCLC achieved its primary endpoint of Overall Response Rate (ORR), both by investigator review and by the Independent Review Committee (IRC) assessment.

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H. Jack West, MD (Posted: August 20, 2019)

If FDA approved, lurbinectedin will emerge as a compelling alternative to topotecan, which remains one of the least favored standards of care in oncology. Many will still be holding out for randomized data with lurbinectedin, which should be provided in the ATLANTIS trial, which is looking at lurbinectedin with doxorubicin. If that trial is positive, I suspect that most people will actually favor using lurbinectedin as a single agent, given the additive myelotoxicity of these agents.

(Reuters) Aug 16, 2019 - Roche Holding AG has priced its personalized cancer treatment, Rozlytrek, at about $17,050 per month, nearly half of the monthly price of a rival drug from Bayer AG and Eli Lilly and Co that was approved last year. Roche’s drug and Bayer/Lilly’s Vitrakvi target tumors with rare genetic anomalies called NTRK fusions, irrespective of where in the body the disease started.

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H. Jack West, MD (Posted: August 19, 2019)

Sad that we live in a world in which a drug priced at $17K a month is being portrayed as a bargain.