ONCS - OncoSec crashes ~60% after TAVO-EP Keytruda combo fails phase 2 skin cancer trial

2023-04-03 08:48:27 ET

OncoSec Medical's ( NASDAQ: ONCS ) TAVO-EP in combination with Merck's ( NYSE: MRK ) Keytruda did not meet the main goal of overall response rate (ORR) in phase 2 trial to treat patients with a type of skin cancer.

The mid-stage study, dubbed KEYNOTE-695, was evaluating TAVO™-EP in combination with Keytruda  (pembrolizumab) to treat patients with unresectable or metastatic (Stage 3/4) melanoma who had confirmed disease progression after at least 12 weeks exposure to immediate prior anti-PD-1 antibody therapy (pembrolizumab or nivolumab).

OncoSec said that among 98 efficacy evaluable patients with at least one post-baseline tumor assessment, the confirmed ORR by blinded independent central review (BICR) assessment was 10.2%, which did not achieve the pre-specified clinically meaningful ORR of ?17%.

The company added that the BICR results for 98 efficacy evaluable patients were lower than the ORR by investigator assessment of 18.8% for the 101 patients previously reported in November 2022 as the key secondary goal of the study.

The company previously reported that the median overall survival for all enrolled 105 patients was 22.7 months, after a median follow-up of 33.4 months.

The combination therapy was generally well tolerated with 4.8% of all enrolled patients experiencing Grade 3 treatment-related adverse events (TRAEs). There were no Grade 4 or Grade 5 TRAEs, according to the company.

"It is disappointing that review by blinded central readers did not confirm the previously reported results by investigator assessment of the KEYNOTE-695 Phase 2 clinical trial in this patient population," said OncoSec's CEO Robert Arch.

The company noted that it plans to pursue TAVO-EP in combination with anti-PD-1 therapy in the neoadjuvant melanoma setting.

OncoSec added that a meeting with the FDA to discuss a phase 2 trial design and future development plans in the melanoma neoadjuvant setting is scheduled in May.

The company had already deferred further development of TAVO-EP to treat TNBC in order to focus its efforts and resources on ongoing development of TAVO-EP in melanoma.

ONCS -60.47% to $1.02 premarket April 3

For further details see: