FDA Grants Fast Track Designation to ONCOS-102 for Treatment of Advanced Melanoma


Targovax announced the FDA granted fast track designation to its investigational agent ONCOS-102 for PD-1–refractory advanced melanoma.

The FDA granted fast track designation to ONCOS-102 for the treatment of patients with PD-1 inhibitor–refractory advanced melanoma, announced the company responsible for agent, Targovax, in a press release.1

This designation was based upon clinical and pre-clinical data regarding immune activation and tumor response observed with the use of ONCOS-102. This designation is in addition to ONCS-102’s designation on malignant pleural mesothelioma.2

“Securing yet another fast track designation is a strong endorsement of the potential for ONCOS-102 to benefit a patient population with high unmet medical need. Fast track simplifies and expedites the regulatory interactions and review process, and further supports the rationale for initiating a phase 2 trial to target accelerated approval for ONCOS-102 in anti–PD-1 refractory melanoma,” Ingunn Munch Lindvig, MD, VP Regulatory Affairs of Targovax, said in a press release.

In a recent phase 1 trial (NCT03003676), investigators used the combination of ONCOS-102 and pembrolizumab (Keytruda) to achieve a 35% objective response rate (ORR) in PD-1 inhibitor–refractory malignant melanoma.3

This 2-part, open-label trial tested the regimen in patients with advanced, unresectable melanoma who had disease progression despite prior treatment with anti–PD-1 checkpoint inhibitor (CPI). The trial included 20 patients, 7 of whom were observed to have tumor responses with the ONCOS-102 and pembrolizumab combination.

Investigators also noted responses in non-injected lesions. Out of the 20 patients, 2 had non-injected lesions completely disappear which indicates that ONCOS-102 has the potential to induce antitumor immunity.

This trial was divided into 2 parts with each having different dosing. In part 1, 9 patients were given 3 intratumoral ONCOS-102 injections the first week, followed by treatment with pembrolizumab every third week up to 24 weeks. Three patients had tumor responses observed in at least 1 CT scan.

In part 2 of the trial, 12 patients were enrolled with an extended dosing regimen of 12 intratumoral ONCOS-102 injections. During the first 2 weeks, patients received 4 injections followed by concomitant administration of ONCOS-102 and pembrolizumab from week 3 and every third week up to 24 weeks. CT scans in 4 out of the 12 patients showed tumor responses.

Of note, patients in the second part had more advanced disease than in part 1. Additionally, both parts had favorable tolerability profiles with no safety concerns.

ONCOS-102 is a oncolytic adenovirus administered by intratumoral injection that is also being tested in mesothelioma and colorectal cancer as monotherapy and in combination with chemotherapy and checkpoint inhibitor therapy.


1. Targovax receives Fast Track designation for ONCOS-102 in melanoma. News Release. Targovax. Published June 22, 2021. Accessed June 22, 2021. https://prn.to/3j3dn2O

2. Targovax receives Fast-Track designation for ONCOS-102. News Release. Targovax. Published June 22, 2021. Accessed June 22, 2021. https://bit.ly/3zOp6b5

3. Targovax announces impressive objective responses as well as effects on non-injected lesions in ONCOS-102 trial in anti-PD1 refractory melanoma patients. News Release. Targovax. Published December 1, 2020. Accessed June 22, 2021. https://bit.ly/3gRDsz3

Related Videos
Experts on myeloma
Related Content