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BMS sets out its first-line NSCLC stall at ASCO

FDA due to deliver verdict on BMS’ marketing application for CheckMate-227 data later today

B-MS building

Bristol-Myers Squibb has laid out the data it hopes will finally extend the use of its PD-1 inhibitor into previously-untreated non-small cell lung cancer (NSCLC), years after a phase 3 fail ceded the territory to Merck & Co’s Keytruda.

Abstracts published ahead of the ASCO congress that starts later this month put more flesh on the bones of the CheckMate-9LA and CheckMate-227 trials, which tested Opdivo (nivolumab) alongside BMS’ CTLA4 inhibitor Yervoy (ipilimumab) – both with and without chemotherapy.

Preliminary overall survival (OS) results from CheckMate-227 were first presented at last year’s ESMO conference, so oncologists already knew that Opdivo coupled with low-dose Yervoy outperformed chemotherapy when given as a first-line therapy for people with NSCLC tumours that had 1% or more PD-L1 expression.

The new ASCO data includes three years of follow-up from the study, and reveals that 33% of patients on BMS’ combination were still alive at the time point, compared to 22% of the chemo group, regardless of their PD-L1 status.

Opdivo/Yervoy also delayed disease progression or death among these patients, with a three-year progression-free survival (PFS) rate of 18% compared to 4% with chemo.

Furthermore, the survival numbers still looked good three years after patients responded to the therapy – at 38% for the combination versus 4% for the control group – ie, well beyond the 24-month treatment period.

The FDA is due to deliver a verdict on BMS’ marketing application for the CheckMate-227 data later today, raising the possibility of a chemo-free immunotherapy that could challenge the standard approach of Keytruda (pembrolizumab) plus chemo in these patients – an indication that accounted for a big chunk of Keytruda’s $12bn sales last year.

The trial has been controversial, however, thanks to changes to the protocol midway through that resulted in the EMA saying it was unable to review the EU filing of the data. BMS subsequently withdrew the application in February this year.

CheckMate-9LA meanwhile compared Opdivo, Yervoy and two cycles of chemo with reduced risk of death by 31% compared to chemotherapy alone at a minimum follow-up of 8.1 months in first-line NSCLC patients recruited regardless of their PD-L1 status.

The benefit was sustained over almost 13 months of follow-up with an OS of 15.6 months with BMS’ drugs and 10.9 months for chemo alone, which was a 34% improvement.

Oncologists point to the reduced chemo burden with the regimen compared to the standard approach of Keytruda with four chemo cycles, and the improved survival rate compared to Opdivo/Yervoy given alone in CheckMate-227.

It’s worth noting, however, that the OS data with both of BMS’ combinations doesn’t look particularly strong against Keytruda plus chemo for previously-untreated NSCLC, which improved OS by 51% compared to chemo – with all the usual caveats of comparing data from different trials.

Opdivo and Yervoy can also be hard to tolerate, which is why BMS opted to use a lower dose of the CTLA4 inhibitor in its combination trials.

The FDA is due to deliver its verdict on the CheckMate-9LA data in August, and if it approves both data sets BMS will finally have an opening in the first-line NSCLC market. Whether that translates into new sales that can get Opdivo back onto a growth track after its sales slipped last year remains to be seen.

Article by
Phil Taylor

15th May 2020

From: Research

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