CAN-2409 Elicits Survival Responses In NSCLC

CAN-2409 elicited responses among patients with pretreated stage 3/4 non–small cell lung cancer: © steph_photographis - stock.adobe.com

Treatment with the immunotherapy agent CAN-2409 elicited responses among patients with stage 3/4 non–small cell lung cancer (NSCLC) whose disease had inadequately responded to treatment with immune checkpoint inhibitor therapy.

The announcement was made in a news release from the clinical stage biopharmaceutical company Candel Therapeutics in a final survival data report from a phase 2a clinical trial of CAN-2409.

The median overall survival with CAN-2409 was 24.5 months among 46 evaluable patients who received two courses of CAN-2409 and 21.5 months among 41 evaluable patients who presented with progressive disease at baseline. These responses are longer than the 9.8 to 11.8 months of survival previously reported in similar patient populations receiving standard-of-care docetaxel chemotherapy, according to the release. Furthermore, 37% of patients with progressive disease following previous immune checkpoint inhibitor treatment, were alive two years after receiving CAN-2409.

Additionally, the median overall survival was 25.4 months among the 33 patients with progressive disease who had non-squamous NSCLC.

An exploratory intention to treat analysis showed a median overall survival of 16.7 months after CAN-2409 administration among 53 patients with non-squamous NSCLC who had progressive disease, while other recent trials have shown a median overall survival of 9.9 to 12.3 months in patients with immune checkpoint inhibitor-refractory, non-squamous NSCLC who received docetaxel chemotherapy.

“Treatment options are quite limited for patients with unresectable NSCLC who progress on anti-PD-1 therapy,” Dr. Charu Aggarwal, the Leslye Heisler Professor for Lung Cancer Excellence at the University of Pennsylvania’s Perelman School of Medicine and principal investigator of the study, said in the news release. “The survival benefit seen in this study is striking, especially when compared to both the current standard of care treatment of docetaxel chemotherapy and other therapies under investigation for this patient group,” she added.

A decrease in the size of uninjected tumors was seen in 69% of patients with multiple lesions (35 patients).

“These updated survival data confirm and strengthen our previously reported findings, demonstrating that CAN-2409 has the potential to extend survival for patients with advanced NSCLC, who have limited treatment options after failing to respond to, or progressing, despite immune checkpoint inhibitor therapy,” Dr. Paul Peter Tak, president and chief executive officer of Candel, noted in the release. “CAN-2409 may represent an entirely new approach to solid tumor treatment, with its unique mechanism of action and favorable safety profile to date, enabling potentially meaningful improvements in outcomes beyond current standard of care. These compelling results mark a potentially transformative advance in our fight against this aggressive disease.”

“The extension of survival in patients with non-squamous disease is notable even when compared to data that have been reported for other investigational products, such as antibody-drug conjugates, for this patient population,” said Dr. W. Garrett Nichols, chief medical officer of Candel. “CAN-2409, in addition to continued immune checkpoint inhibitor treatment, may prolong survival beyond that offered by docetaxel chemotherapy, and has the potential to be better tolerated.”

The U.S. Food and Drug Administration (FDA) previously granted Fast Track Designation to CAN-2409 plus Valtrex (valacyclovir) in combination with immune checkpoint inhibitor therapy for patients with stage 3/4 NSCLC who were resistant to first-line PD-(L)1 inhibitor therapy and did not have activating molecular driver mutations or progressed on directed molecular therapy, according to the news release.

Additionally, the FDA has granted Fast Track Designation to CAN-2409 plus Valtrex for the treatment of patients with pancreatic ductal adenocarcinoma.

CAN-2409 was described in the news release as an off-the-shelf, replication-defective adenovirus engineered to deliver the herpes simplex virus thymidine kinase gene to a patient’s specific tumor and induce an individualized, systemic immune response against the tumor.

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