The US green light for Bristol Myers Squibb’s Opdivo plus chemo for neoadjuvant lung cancer represents one of the fastest approvals on record. The filing, based on the Checkmate-816 study, had only been accepted for review on February 28, but just four days later – over four months before the filing’s Pdufa date – the FDA has given it the thumbs up. Bristol now boasts the first ever immunotherapy for neoadjuvant NSCLC treatment, an important accolade as the company attempts to make up with perioperative Opdivo uses the ground it lost in some metastatic cancers. The neoadjuvant approval puts Opdivo ahead of Roche’s Tecentriq, which was last October greenlit for adjuvant NSCLC in PD-L1-positive patients, and Merck & Co’s Keytruda, whose Keynote-091 trial in a slightly broader adjuvant NSCLC population read out positively in January. In neoadjuvant NSCLC the next anti-PD-(L)1 data catalysts will come from Roche’s Impower-030 and Astrazeneca’s Aegean trials, both of which have seen delays to their expected readouts.
| Selected anti-PD-(L)1 MAb studies in perioperative NSCLC | ||
|---|---|---|
| Neoadjuvant NSCLC | Adjuvant NSCLC | |
| Tecentriq | Impower-030* | Impower-010 |
| Readout delayed from 2021 to 2022 | FDA approved in PD-L1 +ve (≥1%) stage II-IIIA disease, 15 Oct 2021 | |
| Keytruda | Keynote-671 | Keynote-091 (Pearls) |
| 2024 readout | At interim, positive in stage IB-IIIA all-comers but not in ≥50% PD-L1 expressers | |
| Opdivo | Checkmate-816 | Checkmate-77T |
| FDA approved in stage IB-IIIA all-comers, 4 Mar 2022 | 2023-24 readout | |
| Imfinzi | Aegean | Mermaid-1 |
| Readout delayed from 2022 to 2023 | 2024 readout | |
| Source: clinicaltrials.gov & company expectations of timing. *Also has an adjuvant stage. | ||
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