(Biocartis) Jan 22, 2020 - Biocartis Group NV, an innovative molecular diagnostics company, today announces that it has entered into a master collaboration agreement with AstraZeneca, a global science-led biopharmaceutical company. The master collaboration agreement enables the collaborative development and commercialization of Idylla™ based molecular tests in support of AstraZeneca’s pharmaceutical products. The announcement today marks a broadening of the existing partnership1 between Biocartis and AstraZeneca that focused on demonstrating how the unique features of the IdyllaTM platform can overcome the current complexity and long turnaround time of biomarker testing for lung cancer patients.

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H. Jack West, MD (Posted: January 23, 2020)

The main limitation I see here is that we're increasingly looking for a wider range of potentially clinically relevant mutations than just EGFR. Whether as part of an initial workup or in the setting of acquired resistance to a targeted therapy, we're looking for more than one target at a time now.

(Merck) Jan 6, 2020 - Merck, known as MSD outside the United States and Canada, today announced that the Phase 3 KEYNOTE-604 trial investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy met one of its dual primary endpoints of progression-free survival (PFS) in the first-line treatment of patients with extensive stage small cell lung cancer (ES-SCLC). In the study, treatment with KEYTRUDA in combination with chemotherapy (etoposide plus cisplatin or carboplatin) resulted in a statistically significant improvement in PFS compared to chemotherapy alone (HR=0.75 [95% CI, 0.61-0.91]), which was observed at a prior interim analysis.

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H. Jack West, MD (Posted: January 07, 2020)

Perhaps a bit surprising for pembro, which has had the luck or efficacy to usually be just a shade better than others in its class, but this wasn't going to be a high stakes win even if the trial had been positive for OS. To be clear, KEYNOTE-604 being positive for PFS but negative for OS is definitely not a victory when atezolizumab and durvalumab have already demonstrated positive results for OS in the same setting. At best, a third and very redundant entrant into the same market, unless it had looked significantly better than the others. The fact that this trial was negative for OS shouldn't leave us agonizing about how pembro is meaningfully different or inferior. In fact, with a HR of 0.80 that barely missed statistical significance, these results are very similar to IMpower133 and CASPIAN (with atezo and durva, respectively), but those came out just a tiny shade better for OS, with results falling on the statistically significant side in those cases, leaving some debating whether the improvement is enough to be truly impressed by those results. As it is, the pembro results in ES-SCLC are very concordant but don't support the concept that pembro is invariably a bit better than other competing anti-PD1 immune checkpoint inhibitors.

(Merck) Dec 12, 2019 - Merck, known as MSD outside the United States and Canada, announced that KEYTRUDA, Merck’s anti-PD-1 therapy, showed improvements in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) as monotherapy for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC) whose tumors expressed PD-L1 (tumor proportion score [TPS] ≥1%), regardless of KRAS mutational status. These findings, which are based on an exploratory analysis of the pivotal Phase 3 KEYNOTE-042 trial, were presented today in a proffered paper presentation (Abstract #LBA4) at the European Society for Medical Oncology (ESMO) Immuno-Oncology Congress 2019 in Geneva, Switzerland.

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H. Jack West, MD (Posted: December 12, 2019)

I would say that the headline for this is misleading. The key finding is that patients with advanced NSCLC without a KRAS mutation appear to derive little or no benefit from pembrolizumab over chemo alone in KEYNOTE-042. This needs further study, but it is not an endorsement that would lead oncologists to favor pembrolizumab in this setting -- definitely not for those with low tumor PD-L1 expression, and now with a question of whether KRAS wild type (no mutation) should dissuade us from using it in patients even with high tumor PD-L1 expression (50% or higher), in whom we would generally consider pembrolizumab a strong option up to now.