European Society for Medical Oncology Congress

European Society for Medical Oncology Congress

Perspective from Yung Lyou, MD, PhD
Source:

Petrylak DP, et at. Abstract 579MO. Presented at: European Society for Medical Oncology Congress (virtual meeting); Sept. 17-21, 2021.

Disclosures: Bristol Myers Squibb supported this trial. Petrylak reports consultant fees and/or research grants from Ada Cap (Advanced Accelerator Applications), Agensys Inc., Amgen, Astellas, AstraZeneca, Bayer, Bicycle Therapeutics, BioXcel Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Clovis Oncology, Eisai, Eli Lilly, Endocyte, Exelixis, Genentech, Incyte, Innocrin, Ipsen, Janssen, MedImmune, Medivation, Merck, Mirati Therapeutics, Monopteros Therapeutics, Novartis, Pfizer, Pharmacyclics, Progenics, Regeneron, Replimune, Roche, Sanofi Aventis, Seattle Genetics, and Urogen. Please see the abstract for all other researchers’ relevant financial disclosures.
September 24, 2021
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Nivolumab plus rucaparib shows ‘noteworthy activity’ in subset of men with prostate cancer

Perspective from Yung Lyou, MD, PhD
Source:

Petrylak DP, et at. Abstract 579MO. Presented at: European Society for Medical Oncology Congress (virtual meeting); Sept. 17-21, 2021.

Disclosures: Bristol Myers Squibb supported this trial. Petrylak reports consultant fees and/or research grants from Ada Cap (Advanced Accelerator Applications), Agensys Inc., Amgen, Astellas, AstraZeneca, Bayer, Bicycle Therapeutics, BioXcel Therapeutics, Boehringer Ingelheim, Bristol Myers Squibb, Clovis Oncology, Eisai, Eli Lilly, Endocyte, Exelixis, Genentech, Incyte, Innocrin, Ipsen, Janssen, MedImmune, Medivation, Merck, Mirati Therapeutics, Monopteros Therapeutics, Novartis, Pfizer, Pharmacyclics, Progenics, Regeneron, Replimune, Roche, Sanofi Aventis, Seattle Genetics, and Urogen. Please see the abstract for all other researchers’ relevant financial disclosures.
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Nivolumab plus rucaparib demonstrated activity among men with chemotherapy-naive metastatic castration-resistant prostate cancer, according to results of cohort A2 of the CheckMate 9KD trial presented during the virtual ESMO Congress 2021.

“In this cohort of patients ... the combination of nivolumab [Opdivo, Bristol Myers Squibb] and rucaparib [Rubraca, Clovis Oncology] showed clinical efficacy in patients with HRD-positive tumors, with noteworthy activity in those patients harboring BRCA mutations,” Daniel P. Petrylak, MD, professor of medicine and urology at Smilow Cancer Hospital at Yale School of Medicine, said during a presentation. “Clinical activity of the combination was limited in patients with HRD-negative tumors.”

 Results of cohort A2 of the CheckMate 9KD trial.
Data were derived from Petrylak DP, et al. Abstract 579MO. Presented at: European Society for Medical Oncology Congress (virtual meeting); Sept. 17-21, 2021.

Petrylak and colleagues reported final results of cohort A2, which included 71 men (median age, 73 years) with chemotherapy-naive metastatic castration-resistant prostate cancer who received ongoing androgen deprivation therapy and previous therapy with abiraterone, enzalutamide (Xtandi, Pfizer) or apalutamide (Erleada, Janssen Oncology) for metastatic disease but not poly(ADP)-ribose polymerase (PARP) inhibitor treatment. Most of the men (54.9%) had measurable disease, 50.7% had homologous recombination deficiency (HRD)-negative tumors and 23.9% had visceral metastases.

The men received 480 mg nivolumab every 4 weeks plus 600 mg rucaparib twice daily until disease progression or unacceptable toxicity.

Objective response rate and PSA response rate (PSA-RR) among all treated men and those with HRD-positive tumors served as co-primary endpoints. Radiographic PFS, OS and safety served as secondary endpoints.

Median follow-up was 17.5 months. Median treatment duration was 4.6 months with nivolumab and 5.5 months with rucaparib.

Sixty-five men (91.5%) had stopped treatment by the time of the final database lock March 21, most because of disease progression.

Daniel P.  Petrylak, MD
Daniel P. Petrylak

Results showed a confirmed ORR of 15.4% (95% CI, 5.9-30.5) and PSA-RR of 27.3% (95% CI, 17-39.6) overall. Men with HRD-positive vs. HRD-negative disease had higher ORR (25% vs. 5.3%) and PSA-RR (41.9% vs. 14.3%). BRCA1/BRCA2 were the most common mutations in the cohort and were associated with improved outcomes (ORR = 33.3%; PSA-RR = 84.6%).

Median radiographic PFS was 8.1 months (95% CI, 5.6-10.9) and median OS was 20.2 months (14.1-22.8), and both were numerically longer among patients with HRD-positive vs. -negative tumors.

Safety results appeared consistent with the profiles of each individual agent. About half (50.7%) of men experienced grade 3 to grade 4 treatment-related adverse events, including anemia (14.1%) and increased alanine aminotransferase (12.7%). Any-grade treatment-related adverse events occurred among 90.1% of patients and led 23.9% of patients to discontinue therapy. No treatment-related deaths occurred.

“Longer follow-up is needed to better characterize the clinical benefits of adding nivolumab to rucaparib for patients with HRD-positive, chemotherapy-naive metastatic castrate-resistant prostate cancer,” Petrylak said. “The PSA response rate of 84.6% in patients with BRCA-positive tumors justifies further evaluation of this combination in patients with BRCA1 or BRCA2 mutations.”