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Neoadjuvant nivolumab with or without ipilimumab induces response in oral cavity cancer

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Neoadjuvant nivolumab with or without ipilimumab induces response in oral
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06 March 2020

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Neoadjuvant nivolumab with or without ipilimumab was shown to be effective and safe for patients with resectable oral cavity cancer, according to the results of a phase 2 randomized trial presented at the Multidisciplinary Head and Neck Cancers Symposium.

“Both PD-1 inhibitors and CTLA-4 inhibitors act on immune checkpoint receptors on the surface of T cells, and they both work slightly differently,” Jonathan D. Schoenfeld, MD, MPH,

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senior physician at Dana-Farber/Brigham and Women’s Cancer Center and associate professor of radiation oncology at Harvard Medical Center, Healio told me. “Several animal models showed that this combination is more effective than either drug alone.”

Researchers believe the inhibitors target different aspects of the immune response, Schoenfeld said.

“CTLA-4 works to generate an initial immune response, while PD-1 is more active in the tumor microenvironment and inhibits an effective immune response,” he said. “Mechanistically, they complement each other.”

Neoadjuvant nivolumab with or without ipilimumab induces response in oral cavity cancer

Neoadjuvant nivolumab with or without ipilimumab was shown to be effective and safe for patients with resectable oral cavity cancer.

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The analysis by Schoenfeld and colleagues included 29 patients with newly diagnosed squamous cell carcinoma of the oral cavity. The investigators randomly assigned patients to two cycles of the PD-1 inhibitor nivolumab (Opdivo, Bristol-Myers Squibb), dosed at 3 mg/kg, with or without a 1 mg/kg dose of the CTLA-4 inhibitor ipilimumab (Yervoy, Bristol-Myers Squibb) with the first cycle of treatment.

Most patients (n = 16) had oral cancer and all had tumors at stage T2 (n = 20) or higher (n = 9). Seventeen patients (58%) had node-positive disease.

Safety, tolerability and volumetric response — defined as any clinical, radiologic, or pathological decrease in bidirectional measurements — served as the primary endpoints of the study. Researchers set a pre-specified goal to achieve a response rate of 15% in both groups.

Objective response by criteria of RECIST version 1.1, clinicopathological downstaging, pathological response of primary tumor, DFS and OS served as secondary endpoints.

Patients underwent surgery 3 to 7 days after the second cycle of therapy. However, six patients did not receive the full dose of the second cycle due to an infusion reaction (n = 2), toxicity (n = 2), patient choice (n = 1), or concerns about clinical progression (n = 1). An additional patient with T4 disease and evidence of radiologic tumor shrinkage switched to definitive chemoradiation.

“If you treat before surgery, the primary tumor is intact. Other studies have suggested that giving immunotherapy when the tumor is intact may produce a better response because the immune system can be better trained at the site of that primary tumor,” Schoenfeld said. “If you give it early, the hope is that the antitumor response by these drugs may persist for a long period of time even after the therapy is stopped.”

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The results showed an overall volumetric response rate of 69%, a clinicopathologic downstaging rate of 61%, and a 39% rate of moderate or better (>50%) pathologic response.

Investigators observed a volumetric response in 79% of patients receiving nivolumab (n = 14) and 60% of patients receiving nivolumab plus ipilimumab (n = 15), clinical to pathological downstaging in 69% of the nivolumab group vs. 53% of the combination group, and moderate or better pathological response in 23% with nivolumab versus 53% with the combination.

Four patients achieved a pathological response of greater than 90%, including one patient in the nivolumab group and three in the combination group.

After median follow-up of 11 months, 90% of patients remained alive and disease-free.

“Cancer of the oral cavity is a notoriously difficult cancer with a high rate of recurrence and death from the disease, and the side effects of standard treatment are often particularly challenging because the treated area is essential for speaking, swallowing and breathing,” Schoenfeld said in a statement. press release. . “We’re excited about moving immunotherapy earlier to treat more of these curative patients and, in the future, potentially reduce how aggressive their other treatments need to be.” – by John De Rosier

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Reference:

Schoenfeld JD, et al. Summary 1. Presented at: Multidisciplinary Symposium Head and Neck Cancer; February 27-29, 2020; Scottsdale, Arizona.

disclosures: Schoenfeld reports research funding and travel expenses from and/or consultant/advising positions at AstraZeneca, Bristol-Myers Squibb, Debiopharm, Merck, Nanobiotix and Tilos. See summary for all relevant financial disclosures from other researchers.

The post Neoadjuvant nivolumab with or without ipilimumab induces response in oral cavity cancer appeared first on Notesradar.

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