FDA Fast Tracks Novel ADC for Ovarian Cancer Treatment

The FDA will speed up its review of a novel antibody drug conjugate to treat certain patients with gynecologic cancer.

The Food and Drug Administration (FDA) has granted a Fast Track designation to Rina-S (rinatabart sesutecan; PRO1184) for the treatment of patients with folate receptor alpha- (FRα) expressing high-grade serous or endometrioid platinum-resistant ovarian cancer, according to a press release from ProfoundBio, the manufacturer of the drug.

The FDA grants Fast Track designations to drugs that fill an unmet need for a serious illness or condition. By granting one, the agency agrees to work with the company developing the therapy to speed up the review and potential approval. According to the agency’s website, “The purpose is to get important new drugs to the patient earlier.”

"Our receipt of Fast Track designation from the FDA underscores our belief in the tremendous promise of Rina-S as a potential best-in-class FRα ADC to address the significant need for improved treatment options for advanced ovarian cancer," said Naomi Hunder, chief medical officer of ProfoundBio, in the press release.

Rina-S is an antibody drug conjugate that targets FRα. Antibody drug conjugates — also known as ADCs — are a class of drug that works by targeting certain proteins found on cancer cells. Once the agent finds and attaches to the target, it releases the cancer-killing component of the medication. The targeted approach tends to lead to fewer side effects, because it tends to only attack tumor cells.

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"FRα is a highly prevalent antigen in ovarian cancer and Rina-S has shown encouraging antitumor activity and tolerability in our phase 1 dose escalation study in ovarian and endometrial cancer patients across the full spectrum of FRα expression,” Hunder said.

The safety and efficacy of Rina-S is being studied in the phase 1/2 PRO1184-001 clinical trial, which includes patients with locally advanced (spread to nearby tissue) and/or metastatic (spread to different parts of the body) solid tumors, including: epithelial ovarian cancer, endometrial cancer, breast cancer, non-small cell lung cancer and mesothelioma.

The study includes two parts, with the goal of Part A being to determine the best intravenous dosage of Rina-S. Results, which were reported in November 2023, showed that Rina-S has “encouraging antitumor activity and well-tolerated doses in heavily pretreated ovarian and endometrial cancer patients unselected for FRα expression,” according to the release.

Now, Part B of the trial — which is currently enrolling patients in cancer treatment centers across the United States and China — will test the drug in a larger group of patients. The goal of Part B is to conduct a comprehensive analysis of the safety, tolerability and how the drug moves within the body (pharmacokinetics).

Researchers plan on enrolling up to four different cohorts of patients, with up to 20 patients in each cohort. Patients will continue to receive Rina-S until they experience disease progression, unacceptable side effects, investigator decision, consent withdrawal, study termination, pregnancy or death, according to the trial’s listing on clinicaltrials.gov.

Patients will not be eligible for enrollment on the trial if they’ve had another malignancy within the last three years; active central nervous system metastases (though patients with treated, stable central nervous system metastases may be permitted); uncontrolled severe infection; test positive for HBV, HCV or HIV; or used a strong P450 CYP3A inhibitor within the last two weeks.

“We look forward to working closely with the FDA as we progress further clinical development and registrational studies for Rina-S,” Hunder concluded.

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