First Patient Dosed With Novel Combo in Prostate Cancer Trial

A novel combination is being tested in patients with prostate cancer.

The first patient has been dosed in a phase 1/2 trial evaluating a novel treatment combination of gotistobart (BNT316/ONC-392) and Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in certain patients with prostate cancer, according to a news release from OncoC4, Inc., one of the manufacturing companies of gotistobart.

In specific, the phase 1/2 PRESERVE-006 trial is currently evaluating the safety and efficacy (how well treatment works) of the gotistobart-Pluvicto regimen. The patient population includes individuals with metastatic castration-resistant prostate cancer (mCRPC) who experienced disease progression (worsening or spreading of cancer) on an androgen receptor pathway inhibitor, the release reported.

Pluvicto is a type of radioactive drug that treats patients with prostate-specific membrane antigen (PSMA)-positive prostate cancer, which has spread to other parts of the body and does not respond to treatments that lower levels of testosterone, according to the National Cancer Institut. The drug binds to the protein PSMA and provides radiation that destroys present cancer cells.

Gotistobart is a novel next-generation anti-CTLA-4 antibody, developed and manufactured by both OncoC4 and BioNTech, the news release noted. The drug binds to the immune checkpoint receptor CTLA-4, which may block the growth of cancer cells and may destroy them, the release defined.

The phase 1/2 trial included 144 patients throughout 20 sites within the U.S., according to, in which patients were randomized into two treatment arms. The two arms include one where patients receive the gotistobart-Pluvicto combination, and the other arm treats patients with only Pluvicto.

“Advances in the treatment of mCRPC have demonstrated improved outcomes, but a high unmet need remains for additional well-tolerated targeted therapies that can further extend survival in these patients. We look forward to evaluating [gotistobart] in combination with radioligand therapy with the aim to further improve outcomes for patients with this advanced stage of disease,” Dr. David R. Wise, director of the Perlmutter Cancer Center at NYU Langone Health and principal investigator of the phase 1/2 trial, said in the news release.

READ MORE: Drug Shortage of Prostate Cancer Treatment Pluvicto Resolved, FDA Finds

In phase 2 of the trial, the researchers plan to evaluate safety along with efficacy in patients with castration-resistant prostate cancer who had PSMA-positive scans and experienced progression after receiving androgen receptor-targeted drugs. This patient population also did not previously receive Pluvicto, the news release reported.

The primary endpoint (result measured at the end of a study to see if treatment worked) for this portion of the trial will also evaluate whether the gotistobart-Pluvicto regimen will increase progression-free survival (time patients live without their cancer worsening or spreading), compared with standard-of-care, the release stated.

According to, the study began on Dec. 11, 2023, and is expected to complete on June 30, 2027.

Pluvicto was first approved by the FDA in March 2022 for patients with PSMA-positive metastatic castration-resistant prostate cancer, which offered a new treatment option for this patient population that could prolong survival, an expert previously said.

“This therapy is truly a targeted therapy. The radioactive Lu-177 molecules that are a part of Pluvicto [hone] into the tumors,” explained Dr. Richard Wahl, president of the Society of Nuclear Medicine and Molecular Imaging and director of the Mallinckrodt Institute of Radiology at Washington University School of Medicine, in a past interview with CURE®.

“This new nuclear medicine therapy is offered to patients who have developed cancers that are resistant to hormonal therapy and who have received taxane-based chemotherapy but whose cancer has still progressed.”

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