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
Allison Betof Warner, MD, PhD, of Stanford University Medical Center, and Zeynep Eroglu, MD, of H. Lee Moffitt Cancer Center and Research Institute, discusses phase II findings showing that in patients with BRAF-mutant metastatic melanoma, dabrafenib plus trametinib and navitoclax (DTN) was associated with a complete response rate of 20% and an overall response rate of 84%. Additionally, there was a trend toward improved overall survival in patients treated with DTN compared with dabrafenib plus trametinib alone; the difference in overall survival was more pronounced in patients with a smaller tumor burden (Abstract 9511).
The ASCO Post Staff
Thomas E. Hutson, DO, PharmD, of Texas Oncology, discusses the 4-year follow-up results from the CLEAR study for patients with advanced renal cell carcinoma (RCC). The data showed that lenvatinib plus pembrolizumab continues to demonstrate clinically meaningful benefit vs sunitinib in overall and progression-free survival, as well as in overall and complete response rates, in first-line treatment (Abstract 4502).
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).
The ASCO Post Staff
Nirav N. Shah, MD, of the Medical College of Wisconsin, discusses phase II results showing that split-dose R-CHOP offers older patients with diffuse large B-cell lymphoma (DLBCL) an equivalent dose intensity as R-CHOP-21 through a fractionated dosing schedule, improving tolerability. At the end of treatment for these older patients, a complete response rate of 71% was comparable to outcomes with R-CHOP in younger patients with the disease (Abstract 7554).
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).