Seagen Inc. (NASDAQ: SGEN) today announced the first presentation of data evaluating ADCETRIS® (brentuximab vedotin) in combination with an anti-PD-1 checkpoint inhibitor in non-small cell lung cancer (NSCLC) and melanoma, and shared preclinical data for an investigational CD30-directed antibody-drug conjugate (ADC) that uses a novel tripeptide linker. The studies were presented at the Society for Immunotherapy of Cancer (SITC) 38th Annual Meeting, taking place November 3-5, 2023, in San Diego.
“The combination of ADCETRIS and a PD-1 inhibitor to treat solid tumors are intriguing and support continued research,” said Roger Dansey, M.D., President, Research and Development and Chief Medical Officer at Seagen. “We are also encouraged by pre-clinical results for SGN-35T, an investigational next-generation CD30-targeted ADC, and plan to begin enrolling patients in a phase 1 clinical trial soon.”
Phase 2 Study of ADCETRIS plus Pembrolizumab in Solid Tumors
The Phase 2 trial SGN35-033 explored the combination of ADCETRIS with pembrolizumab in 55 patients with non-small cell lung cancer (NSCLC) and 58 patients with melanoma who either had no response to previous anti-PD-1 treatment or who experienced cancer progression after initial response to anti-PD-1 therapy (primary resistant or secondary refractory disease, respectively). NSCLC cohorts were evaluated using RECIST v1.1 and melanoma cohorts were evaluated using immune RECIST (iRECIST).
In NSCLC, the ADCETRIS and pembrolizumab combination demonstrated an objective response rate (ORR) of 8% (95% CI: 0.2, 38.5) and 14% (95% CI: 5.3, 27.9) in patients with primary (n=12) and secondary (n=43) refractory NSCLC, respectively. Disease control rates (DCR) — inclusive of complete responses, partial responses and stable disease — were 67% (CI: 34.9, 90.1) and 72% (CI: 56.3, 84.7), respectively.
In melanoma, the ADCETRIS and pembrolizumab combination demonstrated an ORR of 18% (95% CI: 3.8, 43.4) and 22% (95% CI: 10.6, 37.6), in primary (n=17) and secondary (n=41) refractory metastatic cutaneous melanoma, respectively. DCRs were 71% (CI: 44.0, 89.7) and 80% (CI: 65.1, 91.2), respectively. The study design included melanoma patients who were treated in the study within 90 days of receiving prior anti-PD-1 therapy.