MADRID — Merck’s abstract $MRK on its big study of Keytruda (pembrolizumab) combined with chemo hit early at ESMO, attracting considerable attention for the impressive progression-free survival data the pharma giant posted as a frontline therapy for non-small cell lung cancer.
The scoop: The median PFS hit 19 months for the combo arm compared to 8.9 months for chemo alone. The 18-month overall survival rate was 70% with pembro + chemo and 56% with chemo. That was an easy winner at the FDA and the new mark to beat in the hottest competition in drug development.
Merck’s success in lung cancer has proven to be a game-changer in the rivalry for PD-(L)1 checkpoint dominance with Bristol-Myers Squibb, which is still working at a comeback after an early setback on that front triggered a shakeup at the top of their R&D group.
Now that Merck is the leader, though, they are also the primary target not only for Bristol-Myers, but also AstraZeneca and others who are jockeying combo therapies with an eye for the lead position. AstraZeneca was slammed recently, though, when its combination of Imfinzi (durvaumab) and tremelimumab failed at the first primary endpoint on progression-free survival, though researchers are sticking it out for overall survival results in 2018.
More than half of patients in the Keytruda combination arm responded to treatment, says Merck, compared to approximately one-third in the pem/carbo arm.
“Lung cancer is one of the most common and devastating cancers, and these additional data confirm that Keytruda in combination with pemetrexed and carboplatin has the potential to have a meaningful impact in the lives of many of these patients,” said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories.
Immune Design shows up at ESMO with some encouraging, but early, combo data
Immune Design $IMDZ got things started at #ESMO17 in Madrid with the first glimpse at some positive preliminary data to come out of its mid-stage combo using its immune system activator CMB305 and Genentech’s checkpoint inhibitor Tecentriq (atezolizumab).
In a study that divided 88 patients with NY-ESO-1/positive soft tissue sarcoma between the combo and Tecentriq alone, researchers teased out a few interim data points that show some trends in their direction.
With interim data on 36 patients, investigators highlighted a disease control rate of 61% for the combo — with one partial response — against 28% with no PRs.
Median PFS was 2.6 months vs 1.4 months and while survival data was not mature enough to report at ESMO there was also a disease control rate of 57% with 3 PRs (one unconfirmed) versus 38% in the full study group. Researchers also demonstrated some key biomarker data, including far more targeted anti-NY-ESO-1 T cells and antibodies.
The jury is still out obviously on just what kind of tangible benefit patients can expect, but the biotech highlighted a trend toward improved overall survival. This kind of combo strategy to kick up an immune response with a checkpoint that dismantles a frontline defense mechanism for cancer cells has generated a lot of interest.
“We believe the greater clinical benefit and more robust immune response shown in the combination study arm supports the hypothesis that the combination of an appropriately-designed, next-generation cancer vaccine such as CMB305 with a checkpoint inhibitor is important to produce clinical benefit in a cold tumor such as STS, where checkpoint inhibitors otherwise may have limited efficacy,” said Immune Design CEO Carlos Paya. “In addition, we are pleased to observe the trend towards longer overall survival in patients with an induced anti-NY-ESO-1 immune response, further supporting the positive CMB305 monotherapy data we presented at ASCO in June.”
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