Jaffer A. Ajani, MD, Discusses the Approval of Nivolumab Combinations in Esophageal Squamous Cell Carcinoma

Approval Alert | <b>Nivolumab-Based Regimens for Esophageal Squamous Cell Carcinoma</b>

Jaffer A. Ajani, MD, spoke about the recent approvals of nivolumab plus ipilimumab and nivolumab plus chemotherapy for patients with esophageal squamous cell carcinoma.

CancerNetwork® spoke with Jaffer A. Ajani, MD, professor in the Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine at The University of Texas MD Anderson Cancer Center in Houston, about the recent approvals of nivolumab (Opdivo) plus ipilimumab (Yervoy) and nivolumab plus chemotherapy for patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma.1 The approval is based on results of the phase 3 CheckMate 648 trial (NCT03143153) in which patients were treated with nivolumab in combination with either ipilimumab or chemotherapy or chemotherapy alone as the active control.2 

Transcript:

The Checkmate648 [trial] was a large study with 970 patients with untreated metastatic squamous [cell] carcinoma. It is unique because it had 2 experimental arms, with nivolumab plus chemotherapy and another [arm] was without any chemotherapy of nivolumab and ipilimumab. Both experimental arms were compared with chemotherapy, which has been the standard of care. 

Checkmate648 confirms that when you add a PD-1 inhibitor [to treatment], in this case nivolumab, you do get an advantage in overall survival [OS] in select populations, such as by PD-L1 expression [groups]. uniquely in CheckMate-648,it has the advantage of significant in OS for all patients.

Nivolumab plus ipilimumab also produced an OS advantage for selected patients withPD-L1 expression against chemotherapy, and it produced a survival advantage in all patients irrespective of PD-L1 expression. This is a new chapter in the management of [patients with] advanced esophageal cancer. This really represents an option that we haven’t had.

References

  1. U.S. Food and Drug Administration approves two Opdivo (nivolumab)-based regimens as first-line treatments for unresectable advanced or metastatic esophageal squamous cell carcinoma. News Release. Bristol Myers Squibb. May 27, 2022. Accessed May 31, 2022. https://bit.ly/3GGDd6j
  2. Doki Y, Ajani JA, Kato K, et al. Nivolumab Combination Therapy in Advanced Esophageal Squamous-Cell Carcinoma. N Engl J Med. 2022;386(5):449-462. doi:10.1056/NEJMoa2111380