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).
Transcript
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.
The ASCO Post Staff
Eunice S. Wang, MD, of Roswell Park Comprehensive Cancer Center, and Gregory Roloff, MD, of the University of Chicago, discuss data that are the first to demonstrate post–FDA approval efficacy and toxicity rates of brexucabtagene autoleucel in adults with relapsed or refractory B-cell acute lymphoblastic leukemia. Although the data may confirm high response rates associated with this agent, they also highlight the need for interventions to reduce associated toxicities (Abstract 7001).
The ASCO Post Staff
Bobbie J. Rimel, MD, of Cedars-Sinai Medical Center, and Kathleen N. Moore, MD, of the Stephenson Oklahoma Cancer Center at the University of Oklahoma, discuss phase III results from the MIRASOL trial, which showed that mirvetuximab soravtansine-gynx prolonged overall survival vs investigator’s choice chemotherapy in patients with platinum-resistant ovarian cancer with high folate receptor-alpha expression. The findings suggest a new standard of care for this disease (Abstract LBA5507).
The ASCO Post Staff
Sebastian Stintzing, MD, of the Charité Universitätsmedizin Berlin, discusses results from the phase III FIRE-4 study, which showed that liquid biopsy is clinically relevant in verifying mutational status in patients with metastatic colorectal cancer and is efficacious in first-line treatment of FOLFIRI and cetuximab for patients with RAS wild-type disease (Abstract 3507).
The ASCO Post Staff
Cathy Eng, MD, of Vanderbilt-Ingram Cancer Center, and Lars Henrik Jensen, MD, PhD, of the Danish Colorectal Cancer Center South and the University Hospital of Southern Denmark, discuss phase III results from the Scandinavian NeoCol trial, which showed that neoadjuvant chemotherapy is not superior to standard upfront surgery in terms of disease-free and overall survival in patients with colon cancer, although there are certain circumstances when this approach may have more favorable outcomes (Abstract LBA3503).
The ASCO Post Staff
Muhit Özcan, MD, of Turkey’s Ankara University School of Medicine, discusses phase II findings from the waveLINE-004 study. It showed that the antibody-drug conjugate zilovertamab vedotin had clinically meaningful antitumor activity in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who experienced disease progression after, or have been ineligible for, autologous stem cell transplantation and/or chimeric antigen receptor T-cell therapy (Abstract 7531).