ASCO 2021 | CheckMate 816: addressing unanswered questions on surgical outcomes following neoadjuvant chemo-IO
Jonathan Spicer, MD, PhD, McGill University, Montreal, Canada, talks on the importance of the CheckMate 816 (NCT02998528) trial, a Phase III study evaluating nivolumab plus platinum-doublet chemotherapy versus chemotherapy alone as neoadjuvant treatment for patients with resectable non-small cell lung cancer (NSCLC). In recent years, there has been a growing interest in the use of neoadjuvant approaches in lung cancer and its impact on pathologic complete response and survival outcomes. However, many questions have been raised about the implications of novel neoadjuvant treatments on surgical outcomes. Checkmate 816 is the first Phase III multicenter randomized controlled trial of chemotherapy vs. chemo-immunotherapy (IO) in patients with operable NSCLC to report surgical outcomes. The findings, reported at ASCO 2021, have the potential to address many of the unknowns in this field. This interview took place at the American Society of Clinical Oncology (ASCO) 2021 Virtual Meeting.
Transcript (edited for clarity)
The important thing here is that this is the first phase three results to be reported from a trial involving neoadjuvant chemo-immunotherapy. As you know, there’s been a lot published in the last three or so years on both pathological outcomes and free survival outcomes, and surgical outcomes from various treatment regimens in the neoadjuvant window for operable lung cancer. And at least in the surgical community, there’s been I think a lot of uncertainty as to what exactly the implications of neoadjuvant immunotherapy are for the thoracic surgeon, for the patient undergoing surgery...
The important thing here is that this is the first phase three results to be reported from a trial involving neoadjuvant chemo-immunotherapy. As you know, there’s been a lot published in the last three or so years on both pathological outcomes and free survival outcomes, and surgical outcomes from various treatment regimens in the neoadjuvant window for operable lung cancer. And at least in the surgical community, there’s been I think a lot of uncertainty as to what exactly the implications of neoadjuvant immunotherapy are for the thoracic surgeon, for the patient undergoing surgery. Is the operation more complicated? Do we have to do more of these cases via traditional open approaches? Can they be handled by a non-invasive surgical approach? Are the postoperative outcomes equivalent to untreated patients or patients who have had traditional conventional induction regimen via chemo or chemoradiotherapy?
So I think that’s where this study is so important is that it’s going to give us a little bit more less biased view of what the real outcomes are. It’s a multicenter study conducted in some 150 centers around the world. So it’s also going to give us some external validity to a lot of the findings because a lot of what’s been published so far as high volume academic centers who’ve done phase two trials and usually surgeons who are accustomed to complex scenarios and who were open to exploring these kinds of things. And now it’s a much, much broader and diverse surgical cohort. So I think in that respect, these are extremely important results for the community of surgeons, oncologists treating this kind of disease.
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Disclosures
Dr Spicer reports consultancy for BMS, Merck, AZ, Protalix, Transhit Bio, CLS Therapeutics.
Dr Spicer reports grants from AZ, Roche, Merck, CLS Therapeutics.
