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.
Related Videos
The ASCO Post Staff
Jennifer L. Crombie, MD, of Dana-Farber Cancer Institute, discusses the historically poor outcomes for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). Her study examined real-world data on the use of novel therapies in this population and found that outcomes with second- and third-line regimens of polatuzumab vedotin-piiq plus bendamustine and rituximab and tafasitamab plus lenalidomide remain suboptimal, with worse outcomes particularly after chimeric antigen receptor T-cell therapy (Abstract 7552).
The ASCO Post Staff
Thierry Conroy, MD, of the Institut de Cancérologie de Lorraine, discusses phase III findings from the PRODIGE 23 trial, showing that neoadjuvant chemotherapy with mFOLFIRINOX followed by chemoradiotherapy, surgery, and adjuvant chemotherapy improved all outcomes, including overall survival, in patients with locally advanced rectal cancer compared with standard chemoradiotherapy, surgery, and adjuvant chemotherapy (Abstract LBA3504).
The ASCO Post Staff
Shilpa Gupta, MD, of Cleveland Clinic, discusses the results from the EV-103 study and the unmet need for effective first-line therapies in cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma. After nearly 4 years of follow-up, the trial findings showed that enfortumab vedotin-ejfv plus pembrolizumab continues to demonstrate promising survival trends with rapid and durable responses in this population (Abstract 4505).
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
Christian Pfister, MD, PhD, of Rouen University Hospital, discusses phase III results from the VESPER trial, which showed that dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin provided a better overall survival rate at 5 years and improved disease-specific survival compared with gemcitabine as perioperative chemotherapy in patients with muscle-invasive bladder cancer (Abstract LBA4507).