FDA News

FDA grants fast track designation to ImmunoPulse IL-12 for melanoma

The FDA granted fast track designation to ImmunoPulse IL-12 for the treatment of metastatic melanoma that progressed during therapy with pembrolizumab or nivolumab.

ImmunoPulse IL-12 (OncoSec Medical) is an intratumoral anticancer gene therapy that expresses interleukin-12 (IL-12).

“With the number of melanoma patients now being treated with either pembrolizumab (Keytruda, Merck) or nivolumab (Opdivo, Bristol Myers Squibb) in either the first- or second-line settings, there will be an increasing number of patients who will not respond to therapy,” Punit Dhillon, president and CEO of OncoSec, said in a company-issued press release. “Thus, there is a clear need for treatments that can rescue these patients and help them benefit from these immunotherapies.”

A phase 2 registration trial designed to evaluate ImmunoPulse IL-12 plus pembrolizumab as treatment for unresectable metastatic melanoma showed the combination was active among patients who were not expected to respond to anti–PD-1 therapy alone.

The results — presented this past weekend at the ASCO-SITC Clinical Immuno-Oncology Symposium in Orlando, Florida — showed a 43% overall response rate at 24 weeks and a best ORR of 48% among patients treated with the combination.

Researchers reported a 52% disease control rate; 24% of patients achieved complete response, 19% achieved partial response and 9% demonstrated stable disease.

Nine patients had received prior checkpoint inhibitor therapy, and researchers reported a 33% ORR in this subgroup.

The combination exhibited a favorable safety profile and appeared well tolerated.

“With the recent presentation of our interim data from our ongoing combination study with pembrolizumab in patients predicted not to respond to single-agent anti–PD-1 therapy, we are increasingly confident in ImmunoPulse IL-12 to potentially convert 'cold' tumors to 'hot' tumors to effectively and safely improve the response rates of these patients,” Dhillon said.

The phase 2b PISCES trial — a Simon 2-stage, noncomparative, open-label, single-arm, multicenter study — will evaluate the combination of ImmunoPulse IL-12 and anti–PD-1 therapy in patients with histological diagnosis of melanoma with progressive locally advanced or metastatic disease, defined as stage III or IV, who previously failed an approved anti–PD-1 therapy alone.

The study, expected to begin this year, will evaluate ORR at 24 weeks, best ORR, duration of response, median PFS and OS.

“This fast track designation by the FDA serves as an additional validation for OncoSec’s clinical development program,” Sharron Gargosky, PhD, chief clinical and regulatory officer of OncoSec, said in the press release. “As we launch our upcoming phase 2b PISCES clinical trial, we look forward to collaborating closely with the FDA at this important stage of our clinical program.”

The FDA granted fast track designation to ImmunoPulse IL-12 for the treatment of metastatic melanoma that progressed during therapy with pembrolizumab or nivolumab.

ImmunoPulse IL-12 (OncoSec Medical) is an intratumoral anticancer gene therapy that expresses interleukin-12 (IL-12).

“With the number of melanoma patients now being treated with either pembrolizumab (Keytruda, Merck) or nivolumab (Opdivo, Bristol Myers Squibb) in either the first- or second-line settings, there will be an increasing number of patients who will not respond to therapy,” Punit Dhillon, president and CEO of OncoSec, said in a company-issued press release. “Thus, there is a clear need for treatments that can rescue these patients and help them benefit from these immunotherapies.”

A phase 2 registration trial designed to evaluate ImmunoPulse IL-12 plus pembrolizumab as treatment for unresectable metastatic melanoma showed the combination was active among patients who were not expected to respond to anti–PD-1 therapy alone.

The results — presented this past weekend at the ASCO-SITC Clinical Immuno-Oncology Symposium in Orlando, Florida — showed a 43% overall response rate at 24 weeks and a best ORR of 48% among patients treated with the combination.

Researchers reported a 52% disease control rate; 24% of patients achieved complete response, 19% achieved partial response and 9% demonstrated stable disease.

Nine patients had received prior checkpoint inhibitor therapy, and researchers reported a 33% ORR in this subgroup.

The combination exhibited a favorable safety profile and appeared well tolerated.

“With the recent presentation of our interim data from our ongoing combination study with pembrolizumab in patients predicted not to respond to single-agent anti–PD-1 therapy, we are increasingly confident in ImmunoPulse IL-12 to potentially convert 'cold' tumors to 'hot' tumors to effectively and safely improve the response rates of these patients,” Dhillon said.

The phase 2b PISCES trial — a Simon 2-stage, noncomparative, open-label, single-arm, multicenter study — will evaluate the combination of ImmunoPulse IL-12 and anti–PD-1 therapy in patients with histological diagnosis of melanoma with progressive locally advanced or metastatic disease, defined as stage III or IV, who previously failed an approved anti–PD-1 therapy alone.

The study, expected to begin this year, will evaluate ORR at 24 weeks, best ORR, duration of response, median PFS and OS.

“This fast track designation by the FDA serves as an additional validation for OncoSec’s clinical development program,” Sharron Gargosky, PhD, chief clinical and regulatory officer of OncoSec, said in the press release. “As we launch our upcoming phase 2b PISCES clinical trial, we look forward to collaborating closely with the FDA at this important stage of our clinical program.”

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