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CheckMate 9KD Arm B final analysis: Efficacy and safety of nivolumab plus docetaxel for chemotherapy-naïve metastatic castration-resistant prostate cancer.

Publication ,  Conference
Fizazi, K; González Mella, P; Castellano, D; Minatta, JN; Rezazadeh, A; Shaffer, DR; Vazquez Limon, JC; Sánchez López, HM; Armstrong, AJ; Li, J ...
Published in: Journal of Clinical Oncology
February 20, 2021

12 Background: CheckMate 9KD (NCT03338790) is a phase 2 trial of nivolumab (NIVO; anti-PD-1) in combination with rucaparib, docetaxel (DOCE), or enzalutamide for patients with metastatic castration-resistant prostate cancer (mCRPC). DOCE is a standard-of-care chemotherapy for mCRPC that may potentiate antitumor immune responses, thus supporting its use in combination with NIVO, which has shown limited antitumor activity in mCRPC as monotherapy. We report final analysis results for Arm B (NIVO + DOCE) of CheckMate 9KD. Methods: Arm B enrolled patients with chemotherapy-naive mCRPC with ongoing androgen deprivation therapy and ≤ 2 prior novel antiandrogen therapies (NATs; i.e., abiraterone, enzalutamide, etc.). Patients received NIVO 360 mg + DOCE 75 mg/m Q3W + prednisone 5 mg BID for ≤ 10 cycles, followed by NIVO 480 mg Q4W until disease progression/unacceptable toxicity (up to 2 years). Coprimary endpoints were objective response rate (ORR) and prostate-specific antigen response rate (PSA-RR; defined as a ≥ 50% PSA reduction). Secondary endpoints included radiographic progression-free survival (rPFS), overall survival (OS), and safety. Results: Of 84 treated patients with a median age of 71 years (range: 53-88), 27% had visceral disease and 54% had measurable disease. The median number of docetaxel cycles was 8; the median number of nivolumab doses was 11. Median follow up was 15.2 months. The table displays the efficacy outcomes, which appear to show comparable ORR in patients receiving versus not receiving prior NAT. There was 1 (2.2%) complete objective response and 17 (37.8%) partial responses in 45 patients with measurable disease. Any-grade treatment-related AEs (TRAEs) occurred in 95.2% of patients, most commonly fatigue (39.3%), diarrhea (35.7%), and alopecia (34.5%). Grade 3-4 TRAEs occurred in 47.6% of patients, most commonly neutropenia (16.7%). TRAEs led to discontinuation in 29.8% of patients. The most common immune-related AEs were GI (35.7%) or skin-related (26.2%). There were 3 treatment-related deaths (1 pneumonitis related to NIVO; 2 pneumonias related to DOCE). Conclusions: NIVO + DOCE has encouraging clinical activity in patients with chemotherapy-naïve mCRPC, regardless of prior NAT, with a safety profile consistent with those of the individual agents. These outcomes support the ongoing phase 3 CheckMate 7DX trial of NIVO + DOCE vs placebo + DOCE for mCRPC (NCT04100018). Clinical trial information: NCT03338790. [Table: see text]

Duke Scholars

Published In

Journal of Clinical Oncology

DOI

EISSN

1527-7755

ISSN

0732-183X

Publication Date

February 20, 2021

Volume

39

Issue

6_suppl

Start / End Page

12 / 12

Publisher

American Society of Clinical Oncology (ASCO)

Related Subject Headings

  • Oncology & Carcinogenesis
  • 3211 Oncology and carcinogenesis
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Fizazi, K., González Mella, P., Castellano, D., Minatta, J. N., Rezazadeh, A., Shaffer, D. R., … Pachynski, R. K. (2021). CheckMate 9KD Arm B final analysis: Efficacy and safety of nivolumab plus docetaxel for chemotherapy-naïve metastatic castration-resistant prostate cancer. In Journal of Clinical Oncology (Vol. 39, pp. 12–12). American Society of Clinical Oncology (ASCO). https://doi.org/10.1200/jco.2021.39.6_suppl.12
Fizazi, Karim, Pablo González Mella, Daniel Castellano, Jose Nicolas Minatta, Arash Rezazadeh, David R. Shaffer, Juan Carlos Vazquez Limon, et al. “CheckMate 9KD Arm B final analysis: Efficacy and safety of nivolumab plus docetaxel for chemotherapy-naïve metastatic castration-resistant prostate cancer.” In Journal of Clinical Oncology, 39:12–12. American Society of Clinical Oncology (ASCO), 2021. https://doi.org/10.1200/jco.2021.39.6_suppl.12.
Fizazi K, González Mella P, Castellano D, Minatta JN, Rezazadeh A, Shaffer DR, et al. CheckMate 9KD Arm B final analysis: Efficacy and safety of nivolumab plus docetaxel for chemotherapy-naïve metastatic castration-resistant prostate cancer. In: Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO); 2021. p. 12–12.
Fizazi, Karim, et al. “CheckMate 9KD Arm B final analysis: Efficacy and safety of nivolumab plus docetaxel for chemotherapy-naïve metastatic castration-resistant prostate cancer.Journal of Clinical Oncology, vol. 39, no. 6_suppl, American Society of Clinical Oncology (ASCO), 2021, pp. 12–12. Crossref, doi:10.1200/jco.2021.39.6_suppl.12.
Fizazi K, González Mella P, Castellano D, Minatta JN, Rezazadeh A, Shaffer DR, Vazquez Limon JC, Sánchez López HM, Armstrong AJ, Horvath L, Dzik C, Amin NP, Li J, Unsal-Kacmaz K, Retz M, Saad F, Petrylak DP, Pachynski RK. CheckMate 9KD Arm B final analysis: Efficacy and safety of nivolumab plus docetaxel for chemotherapy-naïve metastatic castration-resistant prostate cancer. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO); 2021. p. 12–12.

Published In

Journal of Clinical Oncology

DOI

EISSN

1527-7755

ISSN

0732-183X

Publication Date

February 20, 2021

Volume

39

Issue

6_suppl

Start / End Page

12 / 12

Publisher

American Society of Clinical Oncology (ASCO)

Related Subject Headings

  • Oncology & Carcinogenesis
  • 3211 Oncology and carcinogenesis
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences