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
Funda Meric-Bernstam, MD, of The University of Texas MD Anderson Cancer Center, discusses interim results from the DESTINY-PanTumor02 trial, the first tumor-agnostic global study of fam-trastuzumab deruxtecan-nxki (T-DXd) in a broad range of HER2-expressing solid tumors. This agent showed an encouraging overall response rate, particularly in patients with IHC 3+ expression; durable clinical benefit; and a manageable safety profile in these heavily pretreated patients. T-DXd may be a potential new treatment option for this population (Abstract LBA3000).
The ASCO Post Staff
Aaron T. Gerds, MD, of Cleveland Clinic Taussig Cancer Institute, talks about treating the anemia many patients with myelofibrosis experience because of JAK inhibitor therapy. The ACE-536-MF-001 study showed that luspatercept improved anemia and transfusion burden in this population, with a safety profile consistent with that in previous studies (Abstract 7016).
The ASCO Post Staff
Nirav N. Shah, MD, of the Medical College of Wisconsin, discusses the efficacy and safety of pirtobrutinib, a highly selective, noncovalent BTK inhibitor, studied for more than 3 years in the BRUIN trial. The results showed that the use of pirtobrutinib continues to have durable efficacy and a favorable safety profile in heavily pretreated patients with relapsed or refractory mantle cell lymphoma and prior BTK inhibitor therapy. Responses were observed in patients with high-risk disease features, including blastoid/pleomorphic variants, elevated Ki67 index, and TP53 mutations (Abstract 7514).
The ASCO Post Staff
Tycel J. Phillips, MD, and Swetha Kambhampati, MD, both of City of Hope National Medical Center, discuss new findings showing that the real-world effectiveness and safety of brexucabtagene autoleucel were similar to data from the pivotal ZUMA-2 trial in patients with relapsed or refractory mantle cell lymphoma, regardless of prior BTK inhibition, bendamustine, or autologous stem cell transplantation (Abstract 7507).
The ASCO Post Staff
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).