FDA Grants Fast Track Designation to RC88 in Ovarian Cancer

Ovarian cancer in woman: ©blueringmedia - stock.adobe.com

• The FDA has granted a fast track designation (FTD) to RC88 for the treatment of platinum-resistant ovarian, fallopian tube, and peritoneal cancers.
• RC88 is a novel mesothelin (MSLN)-targeting antibody-drug conjugate (ADC).
• In December 2023, the FDA approved an international multicenter clinical trial of RC88 (NCT06173037) in this intent-to-treat population.

RC88, an ADC targeting MSLN, has been granted a FTD by the FDA, according to RemeGen.¹

"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, MD, chief executive officer of RemeGen, in a press release.

In December 2023, the FDA approved the investigational new drug application and phase 2 clinical trial of RC88.

The multicenter, single-arm study is taking place in China. The study has a primary end point of overall response rate (ORR) by independent review committee (ICR). Secondary end points include ORR by investigator, duration of response by ICR, progression-free survival (PFS) by IRC, PFS by investigator, overall survival, pharmacokinetics, incidence of anti-drug antibodies, immunohistochemistry, and patient-reported health-related quality-of-life.²

In the trial, patients are receiving a 2.0 mg/kg injection of RC88 on day of every 3-week cycle. Study treatment will continue until disease progression, unacceptable toxicity, withdrawal of consent, death, or study termination.

Patients must have histologically confirmed high-grade serious ovarian, fallopian tube, or peritoneal cancer, received at least 1 but no more than 3 previous lines of therapy (including 1 type of platinum-based therapy), progressed following the most recent line of anticancer therapy, an ECOG performance status of 0 or 1, a life expectancy of at least 12 weeks, and adequate baseline organ function. Patients are not eligible for enrollment in the study if they have untreated or symptomatic central nervous system metastases, clinical symptoms of gastrointestinal obstruction, immunodeficiency, a known active infection, or history of another invasive malignancy.

RC88 is also being investigated in other clinical trials, including a phase 1 study (NCT05508334) assessing the safety and tolerability of RC88 in advanced solid tumors,³ and a phase 1/2 dose-escalation and extension trial (NCT04175847) investigating RC88 in solid tumors^.4 Additionally, RC88 is being combined with toripalimab (JS001; Loqtorzi), an anti-PD-1 monoclonal antibody, for the treatment of advanced solid tumors in a phase 1/2 trial (NCT05804526).⁵

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. http://tinyurl.com/5h47am5h

2. 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://clinicaltrials.gov/study/NCT06173037

3. A study to assess the safety and tolerability of RC88 for patients with advanced solid tumors. ClinicalTrials.gov. Updated January 10, 2024. Accessed January 12, 2024. https://clinicaltrials.gov/study/NCT05508334

4. A phase I/IIa study of RC88-ADC in subjects with advanced malignant solid tumors. ClinicalTrials.gov. Updated December 28, 2023. Accessed January 12, 2024. https://clinicaltrials.gov/study/NCT04175847

5. A study of RC88 combined with JS001 for advanced solid tumors. ClinicalTrials.gov. Updated December 20, 2023. Accessed January 12, 2024. https://clinicaltrials.gov/study/NCT05804526