Tuesday, April 16, 2024

Rinatabart Sesutecan’s Fast Track Designation by FDA for Ovarian Cancer Treatment

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ProfoundBio’s rinatabart sesutecan (Rina-S; PRO1184) has been granted Fast Track designation by the FDA for the treatment of patients with FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer. This novel folate receptor alpha (FRα)–targeted antibody-drug conjugate (ADC) represents a significant advancement in the field of ovarian cancer therapy.

Key Aspects of Rinatabart Sesutecan

  1. Innovative Mechanism of Action: Rinatabart sesutecan is composed of an FRα-directed antibody linked to sesutecan, a cleavable hydrophilic linker, and the topoisomerase 1 inhibitor payload exatecan. This combination targets the FRα, a highly prevalent antigen in ovarian cancer, promising to deliver effective treatment for this disease.
  2. FDA Fast Track Designation: The FDA’s Fast Track designation for Rina-S acknowledges its potential to address the significant need for improved treatment options for advanced ovarian cancer. Naomi Hunder, Chief Medical Officer of ProfoundBio, expressed confidence in the drug’s potential as a best-in-class FRα ADC.
  3. Encouraging Phase I Study Results: In the Phase I dose-escalation study involving ovarian and endometrial cancer patients, Rina-S demonstrated encouraging antitumor activity and tolerability across the full spectrum of FRα expression. This study showed promising results in terms of safety and efficacy.
  4. Optimized Drug Delivery: Sesutecan was developed to mask the hydrophobic nature of conjugated exatecan on the ADC. This allows for a drug-to-antibody ratio of eight, efficiently delivering the drug to tumors while maintaining favorable physicochemical and pharmacokinetic properties.
  5. Safety and Efficacy Data: The safety and efficacy data from the dose-expansion portion of the PRO1184-001 trial indicated that Rina-S was well-tolerated across dosing ranges from 60 mg/m2 to 120 mg/m2. The 140-mg/m2 dose is still under investigation as a potential maximum-tolerated dose (MTD).
  6. Antitumor Activity in Heavily Pretreated Patients: Among 21 efficacy-evaluable patients with ovarian and endometrial cancer, there were significant responses, including one unconfirmed complete response, seven partial responses, and nine cases of stable disease. These responses occurred across FRα expression levels and dose ranges.
  7. Continuing Clinical Development: The PRO1184-001 trial, which included both dose-escalation and dose-expansion phases, aimed to analyze the safety, tolerability, pharmacokinetics, and antitumor activity of Rina-S in patients with various advanced and/or metastatic solid tumors. This comprehensive trial covers multiple cancer types, including epithelial ovarian cancer, endometrial cancer, breast cancer, non–small cell lung cancer, and mesothelioma.Fast Track Designation

FDA’s Fast Track Designation for Rinatabart Sesutecan Signals a New Era in Ovarian Cancer Treatment

In conclusion, the FDA’s Fast Track designation for ProfoundBio’s rinatabart sesutecan is a testament to the drug’s potential in treating FRα-expressing high-grade serous or endometrioid platinum-resistant ovarian cancer. The promising results from the clinical trials, coupled with its innovative mechanism and favorable safety profile, position Rina-S as a potential game-changer in the treatment of ovarian cancer. As clinical trials continue, there is hope that this novel therapy will significantly improve outcomes for patients suffering from this challenging disease.

 

Resource: Pharmexec, January 09, 2024

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