Dr Aggarwal on Data for CAN-2409 Plus Valacyclovir and Continued ICIs in NSCLC

Charu Aggarwal, MD, MPH, FASCO, physician leader, Airways Malignancies Research, director, Precision Oncology Innovation, Penn Center for Cancer Care Innovation, section chief, Head & Neck and Thoracic Cancers, Hematology-Oncology, and Leslye M. Heisler Associate Professor for Lung Cancer Excellence, Penn Medicine, discusses results from a phase 2 trial (NCT04495153) evaluating the combination of CAN-2409 and valacyclovir (Valtrex) and continued standard-of-care immune checkpoint inhibitors for patients with stage III/IV non–small cell lung cancer (NSCLC) who had an inadequate response or were refractory or resistant to anti–PD-1 or –PD-L1 therapy.

At the 2024 ASCO Annual Meeting, Aggarwal and presented topline overall survival data from the phase 2 study. The safety population included 73 patients who received at least 1 injection of CAN-2409. Patients with stable disease following more than 18 weeks of treatment with an immune checkpoint inhibitor–based regimen were enrolled in cohort 1 and received 1 injection of CAN-2409. Those with progressive disease after more than 18 weeks of treatment with an immune checkpoint inhibitor–based regimen were enrolled in cohort 2 and received 2 injections of CAN-2409. Patients also received 2 courses of valacyclovir, and the combination was given with continued standard-of-care checkpoint inhibitors with or without chemotherapy.

Regarding efficacy, Aggarwal notes that in cohort 2, evaluable patients with clinical and radiographic evidence of disease progression after an immune checkpoint inhibitor–based regimen (n = 40), the overall response rate (ORR) was 8%, and the disease control rate (DCR) was 70%. For cohort 1 (n = 5), the ORR was 40%, and the DCR was 100%.

Pooled data from both cohorts showed that at a median follow-up of 20.6 months, the median overall survival (OS) was 22.0 months. In cohort 2, patients had a median OS of 20.6 months.

The most common any-grade treatment-related adverse effects reported in at least 5% of patients included diarrhea (7%), nausea (21%), vomiting (8%), chills (11%), fatigue (32%), influenza-like illness (5%), pyrexia (19%), increased aspartate aminotransferase (5%), increased blood creatinine (10%), decreased appetite (8%), headache (5%), dyspnea (8%), and pneumonitis (5%).