RemeGen's Antibody-Drug Conjugate Gets FDA Fast Track Designation for Ovarian Cancer

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The FDA has granted Fast Track Designation (FTD) to RemeGen Co. Ltd’s mesothelin-targeting antibody-drug conjugate (ADC) RC88 to treat patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancer.¹ Patients diagnosed with aggressive late-stage ovarian cancer experience high expression of mesothelin and have limited treatment options for the disease.

“The FDA’s FTD accelerates the development and review process of RC88, which affirms our commitment to pioneering treatments that address the urgent needs of those facing challenging disease. Moving forward, RemeGen will continue to accelerate the development of its ADC products, with the aim of bringing more and better solutions to patients globally,” said Jianmin Fang, PhD, chief executive officer of RemeGen, in the press release.¹

The selective mesothelin inhibitor is comprised of a recombinant humanized anti-mesothelin antibody that links to the microtubule inhibitor monomethyl auristatin E. RC88 specifically binds to tissues that overexpress mesothelin, which subsequently leads to tumor cell death.

Because of differential expression of mesothelin in malignant tissue and normal tissue, the protein presents an ideal avenue for targeted therapy.² RemeGen was granted an investigational new drug approval in December 2023 to evaluate the medication in Phase II clinical trials.²

An open-label, randomized, dose-optimization Phase II trial (NCT06173037) is assessing the treatment to determine the optimal dosage, efficacy, and safety in patients with platinum-resistant ovarian cancer.¹

Enrollment criteria include being at least 18 years of age with histological confirmation of platinum-resistant disease; prior treatment with at least one but no more than three lines of systemic therapy that included at least one type of platinum-based therapy; documented radiographic progression on or after the most recent line of anticancer treatment; ECOG performance status of 0 or 1; life expectancy of at least 12 weeks; an archival tumor tissue sample or fresh biopsy for mesothelin testing; and adequate hematologic, liver, cardiac, and kidney function.

Patients must also have completed previous systemic therapy within five half-lives or four weeks prior to the first dose of RC88 and focal radiation at least two weeks prior to the first dose of the drug. Investigators will enroll approximately 88 eligible patients, all of whom will receive 2.0 mg/kg of RC88 monotherapy on day one of every three-week cycle until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination by the sponsor.

All patients will receive assessments of their tumor, which includes radiological assessments by CT/MRI scans at screening and every six weeks (± one week) from cycle one, day one for the first 48 weeks, then every 12 weeks (± one week) until disease progression, death, initiation of new anticancer treatment, or patient withdrawal.³

All patients discontinuing RC88 will be monitored for survival every three months (± two weeks) until death, loss to follow-up, withdrawal of consent for survival follow-up, or end of study.

The trial’s primary outcome measure is overall response rate (ORR) by independent review committee, with secondary endpoints that include ORR by investigator; IRC- and investigator-assessed duration of response; progression-free survival; overall survival; pharmacokinetics; and quality of life.

References

1. RemeGen’s RC88 obtained FDA fast track designation, heralds new hope for ovarian cancer patients. News release. RemeGen. January 12, 2024. Accessed January 12, 2024. https://www.prnewswire.com/news-releases/remegens-rc88-obtained-fda-fast-track-designation-heralds-new-hope-for-ovarian-cancer-patients-302033529.html

2. RemeGen’s pioneering RC88 receives IND approval from US FDA for platinum-resistant recurrent ovarian cancer treatment. News release. RemeGen. December 28, 2023. Accessed January 12, 2024. https://www.prnewswire.com/apac/news-releases/remegens-pioneering-rc88-receives-ind-approval-from-us-fda-for-platinum-resistant-recurrent-ovarian-cancer-treatment-302023170.html

3. RC88 in platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer. ClinicalTrials.gov. Updated December 15, 2023. Accessed January 12, 2024. https://classic.clinicaltrials.gov/ct2/show/NCT06173037