Drew Moghanaki, MD, MPH, the Stanley Iezman and Nancy Stark Endowed chair, Thoracic Radiation Oncology Research, professor, chief of Thoracic Oncology, Department of Radiation Oncology, the University of California, Los Angeles (UCA), discusses questions that still need to be addressed following the phase 3 CheckMate-816 trial (NCT02998528) of the neoadjuvant combination nivolumab (Opdivo) plus chemotherapy in patients with non–small cell lung cancer (NSCLC).

the FDA approved nivolumab plus platinum-doublet chemotherapy for adult patients with resectable NSCLC

 in the neoadjuvant setting, based on findings from CheckMate-816.

Data from the trial showed that patients treated with the combination (n = 179) experienced a median event-free survival of 31.6 months (95% CI, 30.2–not reached), compared with 20.8 months (95% CI, 14.0-26.7) with patients given chemotherapy alone (n = 179; HR, 0.63; 95% CI, 0.45-0.87; 

 =.0052). Additionally, nivolumab plus chemotherapy elicited a pathologic complete response (pCR) rate of 24% (95% CI, 18.0%-31.0%) vs 2.2% (95% CI, 0.6%-5.6%) with chemotherapy alone.

The trial included patients with newly diagnosed, resectable, stage IB to IIIA NSCLC who had an ECOG performance status of 0 or 1 and no known sensitizing 

Despite the benefits observed with the combination during the trial, the study did not address whether patients who are eligible to receive either pre-operative chemotherapy or chemoimmunotherapy checkpoint inhibitors should be treated with a chemoradiation approach instead, Moghanaki says.

Although outcomes can be good for patients who achieve a pCR, investigators next need to learn how to identify those patients who are not going to respond well to chemoimmunotherapy, according to Moghanaki. Clinicians must also identify patients with residual disease in order to know when to further escalate treatment to keep increasing the cure rate for this population, Moghanaki concludes.

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Drew Moghanaki, MD, MPH, discusses questions that still need to be addressed following the phase 3 CheckMate-816 trial of the neoadjuvant combination nivolumab plus chemotherapy in patients with non–small cell lung cancer. 

Dr. Moghanaki on Remaining Questions Following the CheckMate-816 Trial in NSCLC

Drew Moghanaki, MD, MPH, associate professor, Department of Radiation Oncology, Emory School of Medicine, Winship Cancer Institute, section chief, Department of Radiation Oncology, Atlanta VA Medical Center, discusses the impact of the PACIFIC trial on stage III lung cancer treatment.

When the PACIFIC trial was first reported in 2017, there was cautious optimism even though it was a randomized, double-blind study, explains Moghanaki. Even with a progression-free survival gain, Moghanaki says people were still skeptical about the overall survival curves separating because of prior negative trials. Moghanaki describes the PACIFIC study’s publication in the New England Journal of Medicine in 2018 an “ecstatic moment” to see the needle move so much.

The PACIFIC trial is significant because the control arm continues to do better than the historical control. Therefore, researchers know staging and more precise radiation delivery that’s less toxic than before is being developed. Moghanaki believes these data have generated more hope in the oncology community for this patient population. Now, if a patient is diagnosed with stage III disease, there are more treatment options than there were previously.

Drew Moghanaki, MD, MPH, discusses the impact of the PACIFIC trial on stage III lung cancer treatment.

Drew Moghanaki, MD, MPH

Articles

Dr. Moghanaki on Remaining Questions Following the CheckMate-816 Trial in NSCLC

Dr. Moghanaki on the Impact of the PACIFIC Trial on NSCLC Treatment