(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)

This 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.

(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)

Important 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.

(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)

This 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.