Just days after MSD claimed an FDA approval for Keytruda as a pre- and post-surgery option for early non-small cell lung cancer (NSCLC), Bristol-Myers Squibb has staked a claim for its rival PD-1 inhibitor Opdivo in the same setting.
The results of the phase 3 CheckMate-77T trial, reported at the ESMO conference, showed that a regimen of neoadjuvant Opdivo (nivolumab) plus chemotherapy, followed by Opdivo on its own as an adjuvant therapy, improved event-free survival (EFS) by 42%.
The regimen was compared to a control group that received neoadjuvant chemotherapy plus placebo and adjuvant placebo in 452 patients with resectable stage IIA to IIIB NSCLC.
Last week, MSD’s Keytruda (pembrolizumab) was approved by the FDA for as perioperative neoadjuvant/adjuvant therapy for patients with stage II, IIIA, or IIIB NSCLC tumours that are 4cm or larger or affecting lymph nodes, and treatable with surgical resection.
The CheckMate-77T results reported at ESMO showed that the median EFS had not yet been reached with a follow-up of just over 25 months, while for the placebo group it was determined to be 18.4 months.
Opdivo also outperformed the placebo group on secondary endpoints, including pathologic complete response – at 25.3% and 4.7%, respectively – as well as major pathologic response which was seen in 35.4% of patients treated with the PD-1 drug and 12.1% of the control group.
The size of the improvement in the trial was right in line with that seen with Keytruda in the Keynote-671 study that supported its FDA approval as a perioperative therapy, suggesting BMS should have a good chance of getting a green light for Opdivo in this setting as well.
Keytruda’s lead in the category and dominant position in NSCLC overall could make it tough to dislodge, although Opdivo has one key advantage in that it was the first drug in the PD-1/PD-L1 class to get FDA approval as neoadjuvant therapy for early-stage NSCLC, so oncologists will already have experience using the drug in these patients.
However, Keytruda also has overall survival (OS) in hand from Keynote-671, a significant 28% reduction in the risk of death reported at ESMO – an important result given that patients with this form of lung cancer are at high risk of recurrence – while BMS is still following up patients to get a view of OS in its trial.
Other options for patients could meanwhile also be on the way from other drugs in the PD-1/PD-L1 class. Roche’s Tecentriq (atezolizumab) and AstraZeneca’s Imfinzi (durvalumab) are both being tested in the perioperative setting for early-stage NSCLC, in the LCMC3 and AEGEAN trials, respectively.
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