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Merck’s Keytruda meets survival challenge in NSCLC

Data showed that almost 70% of patients on the combo were still alive after 12 months


Merck & Co’s grip on the first-line non-small cell lung cancer (NSCLC) immunotherapy market seems set to tighten, after its PD-1 inhibitor Keytruda halved the risk of death in a chemotherapy combination trial.

The first look at data from the KEYNOTE-189 study, presented at the American Association for Cancer Research (AACR) annual meeting, showed that overall survival (OS) in previously-untreated patients with advanced, non-squamous NSCLC was significantly improved with Keytruda (pembrolizumab) plus chemo, with the risk of death 51% lower than with chemo alone.

Almost 70% of patients on the combination were still alive after 12 months, compared to 49% of the chemotherapy group.

It’s another win for Merck in this treatment space over rival Bristol-Myers Squibb, whose PD-1 inhibitor Opdivo (nivolumab) has struggled to find purchase in first-line NSCLC after failing to show a benefit in an all-comer pivotal trial in 2016. Merck took a narrower approach in its studies, focusing on patients with higher levels of PD-L1 expression, but with the latest study has now reached the gold-standard of having shown as OS improvement in a broad patient population.

Earlier this month, Merck also reported data showing that Keytruda improved OS compared to platinum chemotherapy when given as a monotherapy in this setting.

The new data “has the potential to change the treatment paradigm” for NSCLC patients whose tumours are either PD-L1-negative or untested, said Roger Perlmutter, head of Merck Research Laboratories. The company is now preparing to file the data with regulators around with world to bolster the label for Keytruda, which is already the only cancer immunotherapy approved for use with chemotherapy in first-line NSCLC.

BMS is trying to gain ground in lung cancer via the CheckMate -227 trial combining Opdivo with its CTLA4 inhibitor Yervoy (ipilimumab), and at AACR reported that the duo almost doubled the response rate compared to chemotherapy in first-line NSCLC patients with a high tumour mutation burden (TMB).

Progression-free survival (PFS) was almost three times that of the chemo group at 43% versus 13%, and there was a trend towards improvement in OS although the data on that won’t be mature for some time.

BMS is positioning its combination as a chemotherapy-sparing option, but investor reaction suggests Merck is in the ascendency, with its shares rising on the data while BMS and other cancer immunotherapy companies were under pressure.

A Bloomberg report suggests Keytruda is on course to outsell Opdivo for the first time this year, despite BMS’ drug making it to the market first, while analyst Sam Fazeli in the company’s intelligence unit said it would help push sales of Merck’s drug above $11bn in 2022. That’s not to say Opdivo won’t also do well - he’s predicting sales of BMS’ drug will be just below $10bn in that year, thanks to approval in a broad range of cancer indications.

Article by
Phil Taylor

17th April 2018

From: Research



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