(AstraZeneca) Apr 24, 2018 - AstraZeneca and MedImmune, its global biologics research and development arm, today announced high-level results from the Phase III ARCTIC trial in patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least two prior treatments.

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

This is a disappointing result, particularly considering how low the bar is to beat third line standard of care in advanced NSCLC, and in the context of so many positive trials of immunotherapy in other lung cancer settings. Moreover, this report should only further lower our expectations for the MYSTIC trial with this combination in first line NSCLC (if that's possible at this point) and I think causes some collateral damage to nivo/ipi as another PD-L1/CTLA-4 inhibitor combination that is "on the bubble" in terms of how to interpret the data thus far. Perhaps the results would look convincingly more favorable if AZ were to focus on a molecularly defined subset, as BMS morphed the recent CheckMate 227 AACR presentation and publication into a focus on patients with high tumor mutation burden. Regardless, this is unwelcome news for a checkpoint inhibitor strategy several steps behind others in NSCLC.

(BMS) Apr 18, 2018 - Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review its supplemental Biologics License Application for Opdivo (nivolumab) to treat patients with small cell lung cancer (SCLC) whose disease has progressed after two or more prior lines of therapy. The FDA action date is August 16, 2018.

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

This will be a welcome addition to our very limited armamentarium for small cell lung cancer. This is a setting in which topotecan is approved, but I don't think there's another approved agent in oncology less enthusiastically endorsed in practice. It's activity is very marginal, toxicity is significant, particularly if administered as it was actually approved, at a dose that is extremely prone to prohibitive myelosuppression. Based on these issues, those who treat relapsed small cell lung cancer have eagerly awaited ANY viable alternative. Though only a minority of patients respond well to nivolumab, the same can be said for topotecan, but nivolumab is typically associated with far more manageable and modest toxicities, and there is a real chance for a more sustained benefit than we could ever anticipate with more conventional chemotherapy. Notably, nivolumab is already listed as a leading consideration in the NCCN guidelines, but it would be very welcome to have a formal FDA approval for nivolumab in this setting. We can also look forward to far more clinical data on nivolumab +/- ipilimumab in SCLC in the coming years.

(AstraZeneca) Apr 18, 2018 - AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Tagrisso (osimertinib) for the 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) mutations, (exon 19 deletions or exon 21 L858R mutations), as detected by an FDA-approved test.

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

A long overdue approval that most lung cancer specialists should have come shortly after presentation of the FLAURA trial comparing first line osimertinib to "standard of care" first generation EGFR TKI (either gefitinib or erlotinib) in systemic therapy-naive EGFR mutation-positive NSCLC. The PFS benefit was very substantial (median 18.9 vs. 10.2 mo, HR below 0.5), and osimertinib also has much greater CNS activity to control the risk of future brain mets (quite common in EGFR mutation-positive NSCLC) and also has a more favorable toxicity profile. Though some oncologists and patients will invariably want to hold out on osimertinib and "save" it as a second line therapy to preserve a backup option, that's an erroneous approach, I would content. If it's reserved for later, a maximum of only 50-60% of patients who develop T790M-positive acquired resistance will qualify for it, and only a limited subset of those patients will actually undergo testing to find it. If osimertinib is used as first line therapy, 100% of eligible patients will receive the benefits from it. If it is reserved for second line, likely well under 50% and more like 30-40% of initially eligible patients will ultimately receive it. Overall, the population will likely to far better by starting with osimertinib.