RC88 is a mesothelin-targeting antibody-drug conjugate that offers a novel approach to treating platinum-resistant ovarian, fallopian tube, and peritoneal cancers.
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