Alpha Holdings "Oncosec, Increase in Complete Remission Patients in Melanoma 2b Combination Clinical Trial"

[Asia Economy Reporter Hyunseok Yoo] Alpha Holdings announced on the 10th that its affiliate OncoSec disclosed the 'KEYNOTE-695' melanoma clinical phase 2b data at the Society for Immunotherapy of Cancer (SITC) 2020.

At SITC, OncoSec presented clinical data showing that among 54 melanoma patients, there were 3 complete responses and 13 partial responses, resulting in an objective response rate (ORR) of 30% and a complete response (CR) rate of 6%. Notably, among 17 patients in the difficult-to-treat stage 4 melanoma M1C (other distant metastases excluding the central nervous system) or M1D (central nervous system metastases), 6 showed responses, yielding an ORR of 35%.

The KEYNOTE-695 clinical trial disclosed by OncoSec at SITC targets melanoma stage 3/4 patients who showed no effect despite receiving first-line immune checkpoint inhibitors such as Keytruda and Opdivo. This clinical trial involves combination therapy of Merck's Keytruda and OncoSec's interleukin-12 therapeutic Tavo (TAVO), conducted on malignant patients.

This clinical data was selected for the Poster Walk discussion at SITC. Additional presentations are scheduled at the SITC symposium on the 11th. Furthermore, a corporate presentation (IR) will be held on the 12th of the same month for U.S. bio analysts and institutional investors.

According to the initial KEYNOTE-695 clinical data disclosed by OncoSec in February 2019, an ORR of 24% was recorded among 21 patients. Despite the increase in clinical patient numbers from 21 to 54 in the data disclosed at SITC, the ORR rose from 24% to 30%, demonstrating the excellent therapeutic effect of Tavo (TAVO). Considering that the clinical subjects are stage 3/4 patients who had previously undergone more than four treatments including Keytruda and Opdivo, the company explained that the 30% ORR is highly significant.

The number of complete responders also increased from 1 in the February 2019 announcement to 3 in the current SITC presentation. Among patients showing partial responses, there is a high possibility that they will be evaluated as complete responders over time. This is because immune checkpoint inhibitors enhance immune responses and increase efficacy as time passes.

Daniel O'Connor, CEO of OncoSec, stated, “Effective treatment options are essential for late-stage melanoma patients, and this clinical data demonstrated not only the strong therapeutic effect of Tavo but also its low side effects,” emphasizing, “It will be possible to provide patients with a low-cost and simple treatment method in the future.”

KEYNOTE-695 plans to recruit 100 melanoma patients by the fourth quarter of 2020. It was designated as a ‘Fast Track’ and ‘Orphan Drug’ by the U.S. FDA in 2017. Based on accelerated approval, FDA approval is expected in 2022 when the clinical data is completed.

An Alpha Holdings official said, “An objective response rate of over 30% in second-line treatment for melanoma patients who do not respond to Keytruda indicates a competitive new drug,” adding, “Unlike some competing immune checkpoint inhibitors, despite the increase in clinical patient numbers, the rise in ORR data proves the efficacy of the drug as an anticancer agent.”