Omid Hamid, MD, on Advanced Melanoma: Durable Response With Fianlimab Plus Cemiplimab
2023 ASCO Annual Meeting
Omid Hamid, MD, of The Angeles Clinic & Research Institute, discusses study findings on fianlimab plus cemiplimab-rwlc, which showed clinical activity in patients with advanced melanoma, comparing favorably with other approved combinations of immune checkpoint inhibitors in the same clinical setting. This is the first indication that dual LAG-3 blockade may produce a high level of activity with significant overall response rate after adjuvant anti–PD-1 treatment. A phase III trial of this regimen in treatment-naive patients with advanced melanoma is ongoing (Abstract 9501).
Disclaimer: This video transcript has not been proofread or edited and may contain errors.
Omid Hamid, MD:
This study enrolled patients with advanced or metastatic melanoma who had not seen anti-PD-1 antibody in the advanced stage. We treated these patients with melanoma in three cohorts with fianlimab, which is an anti-LAG-3 antibody and cemiplimab, an anti-PD-1 antibody at doses of 1,600 milligrams and 350 milligrams every three weeks. This is important because it's a higher dose of anti-LAG antibody and an increased frequency of dosing. There were three cohorts. The first cohort had patients who had seen a non-PD-1 prior therapy, the second had a treatment naive patients, and the third were for patients who had seen adjuvant PD-1 therapy and had more than six months without recurrence and then became advanced and were treated. What we saw in these patients in these sequentially accrued groups was a high response rate, 63%, 63%, and 56% in the prior adjuvant therapeutic group.
The disease control rate was equally impressive, 80%, 80%, and 67%. The duration of response has not been reached in any of these cohorts. What we saw in terms of toxicity was consistent with prior PD-1 LAG-3 combinations with an increased incidence of manageable adrenal insufficiency. For me, the most important subset of patients here is the third cohort. For patients who had seen prior PD-1 in the adjuvant setting and then recurred after six months, we see a 62% response rate and a progression-free survival of 12 months. This is the best and highest response and control in patients who have seen prior PD-1 reported to date. The duration of response here has not been reached, and in all patients, a progression-free survival of 15 months was seen, which compares favorably in response rate, duration of response, toxicities, and progression-free survival of other cohorts of patients presented in relativity 47 or checkmate 67.
Lisa A. Carey, MD, of the University of North Carolina at Chapel Hill, and Dennis J. Slamon, MD, PhD, of the University of California, Los Angeles, discuss phase III study findings on ribociclib plus endocrine therapy as adjuvant treatment in patients with hormone receptor–positive, HER2-negative early breast cancer. When added to standard-of-care endocrine therapy, ribociclib improved invasive disease–free survival with a well-tolerated safety profile (Abstract LBA500).
Alicia K. Morgans, MD, MPH, of Dana-Farber Cancer Institute, and Karim Fizazi, MD, of Institut Gustave Roussy, University of Paris-Saclay, discuss findings from the TALAPRO-2 study, which showed that talazoparib plus enzalutamide improved radiographic progression–free survival over standard-of-care enzalutamide as first-line treatment for patients with metastatic castration-resistant prostate cancer and HRR gene alterations. This regimen also delayed the time to deterioration in global health status and quality of life (Abstract 5004).
Arlene O. Siefker-Radtke, MD, of The University of Texas MD Anderson Cancer Center, discusses phase III findings showing that for patients with advanced or metastatic urothelial carcinoma and FGFR alteration who already had been treated with a PD-(L)1 inhibitor, erdafitinib significantly improved overall and progression-free survival, as well as overall response rate, compared with investigator’s choice of chemotherapy (LBA4619).
James Chih-Hsin Yang, MD, PhD, of the National Taiwan University Hospital and National Taiwan University Cancer Center, discusses the latest data from the phase III KEYNOTE-789 study, which evaluated the efficacy and safety of pemetrexed plus platinum chemotherapy (carboplatin or cisplatin) with or without pembrolizumab in the treatment of adults with EGFR tyrosine kinase inhibitor–resistant, EGFR–mutated, metastatic nonsquamous non–small cell lung cancer (NSCLC) (Abstract LBA9000).
Bobbie J. Rimel, MD, of Cedars-Sinai Medical Center, and Isabelle L. Ray-Coquard, MD, PhD, of Centre Léon Bérard and the University Claude Bernard Lyon Est, discuss findings from the COLIBRI trial, which showed that, for patients with cervical squamous cell carcinoma, neoadjuvant nivolumab plus ipilimumab is safe and orchestrates de novo immune responses. The 82.5% complete response rate for primary tumors 6 months after standard chemoradiation therapy suggests favorable clinical outcomes (Abstract 5501).