Ovarian cancer treatment on fast track for FDA approval as chemo alternatives emerge: 'We're making progress'

A new wave of cancer treatments is looking promising for the future of oncologic care.

The ovarian cancer drug RC88, which is made by the Chinese biopharmaceutical company RemeGen, received FDA approval for Phase 2 clinical trials earlier this month.

The drug received fast-track designation (FTD) for the treatment of "platinum-resistant recurrent epithelial ovarian, fallopian tube and primary peritoneal cancers," the company confirmed to Fox News Digital.

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RC88 is an antibody-drug conjugate (ADC) designed to treat aggressive ovarian cancers in patients with "poor prognosis," according to the company. 

An ADC is "a class of drugs designed as a targeted therapy for treating disease," per the National Institutes of Health.

RC88 aims to treat aggressive ovarian cancers in patients with a poor prognosis, according to RemeGen, the China-based company that makes the drug. (iStock)

The drug targets mesothelin, a protein found in tumors.

"This development is not just a scientific advancement, but a beacon of hope for countless women battling this formidable disease," a RemeGen spokesperson said in an email to Fox News Digital.

RemeGen intends to launch international and multicenter clinical studies in the U.S., China, the European Union and other regions, according to a press release.

The new drug received fast-track designation (FTD) for the treatment of "platinum-resistant recurrent epithelial ovarian, fallopian tube and primary peritoneal cancers," RemeGen confirmed to Fox News Digital. (iStock)

The clinical trials will study participants in multiple countries to determine optimal dosage, effectiveness and safety of the treatment.

RC88’s clinical data findings are slated to be released at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in May 2024 in Chicago.

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Dr. Brian Slomovitz, director of gynecologic oncology and co-chair of the Cancer Research Committee at Mount Sinai Medical Center in Miami Beach, Florida, is familiar with RemeGen’s treatment, noting that anti-drug conjugates have surfaced as a "relatively new class of drug."

He told Fox News Digital in an interview, "[It] definitely has a lot of promise," noting also that there have been many more failures than successes.

Brian Slomovitz, M.D., is director of Gynecologic Oncology and co-chair of the Cancer Research Committee at Mount Sinai Medical Center in Miami Beach, Florida. He noted the "promise" of the ovarian cancer drug RC88. (Mount Sinai Medical Center)

Among those successes is an ADC drug called Elahere (mirvetuximab soravtansine-gynx), which is indicated for FRa positive, platinum-resistant epithelial ovarian, fallopian tube, or peritoneal cancer.

The FDA granted accelerated approval for Elahere in Nov. 2022, according to an agency press release.

Other ADCs in development include a drug called TIVDAK for cervical cancer as well as anti-HER2 treatments for breast cancer, according to Slomovitz.

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"It’s going to be much more effective than [chemo drug] Herceptin," he predicted. "So, it's really a novel class [of drugs] that go into the cells in a unique way."

Phase 3 clinical trials of TIVDAK (tisotumab vedotin) were linked to a 30% overall reduction in the risk of death compared to chemotherapy.

A cancer doctor described ADC approaches to treating cancer as a "novel class [of drugs] that go into the cells in a unique way." (iStock)

In a previous interview with Fox News Digital, Dr. Kathleen Moore, associate director of clinical research at Stephenson Cancer Center in Oklahoma City, shared that the TIVDAK therapy has been effective in shrinking her own patients' tumors.

"In the past, we just did not have active medications and our patients really were left with ineffective therapies, and they just died," she said. "They’re feeling better because their disease is shrinking."

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During the 2023 European Society of Medical Oncology Congress in Madrid, Spain, Moore presented another ADC treatment called raludotatug deruxtecan (R-DXd), which was confirmed as "efficacious" by the National Library of Medicine in treating ovarian and kidney cancers.

As ovarian cancer develops, the level of mesothelia increases — which gives RC88 its "unique" target. 

"R-DXd is the first ADC targeting CDH6, [which has been] tested in ovarian cancer and demonstrates very strong signals of efficacy," Moore said in her data presentation, according to OncLive, the Oncology Specialty Group's website.

Seventy percent of women who were diagnosed with epithelial ovarian cancer (EOC) have already reached an advanced stage, according to RemeGen.

Phase 3 clinical trials of TIVDAK (tisotumab vedotin) were linked to a 30% overall reduction in the risk of death compared to chemotherapy. (iStock)

EOC remains a "significant cause of cancer deaths among women," as there are "no effective screening methods" and most patients experience a relapse within two years, the company added.

As ovarian cancer develops, the level of mesothelia increases — which gives RC88 its "unique" target, the RemeGen press release stated.

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The FDA's approval of RC88 as an investigational new drug "marks a pivotal moment in our commitment to address the challenges of platinum-resistant recurrent ovarian cancer," RemeGen CEO Dr. Jianmin Fang wrote in a statement to Fox News Digital. 

RemeGen calls RC88 — given its "unique targeting mechanism" — a "beacon of hope for countless women battling this formidable disease." (iStock)

"Our focus remains on developing innovative treatments that can significantly improve patient outcomes in areas with critical unmet needs," he said.

"RC88, with its unique targeting mechanism, exemplifies our dedication to pioneering advancements in cancer therapy."

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It’s important that ADCs are continuously studied, Slomovitz noted, as the bar for approval is "getting higher and higher."

He added, "The good news is, we’re making progress."

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