KEY TAKEAWAYS
- KEYLYNK-010 Phase 3 trial was aimed at mCRPC patients with prior NHA+Docetaxel treatment and their response to the pembro + ola treatment.
- 529 patients were given pembro + ola medication while 264 received NHA, the PROs were then compared on several parameters, including FACT-P, BPI-SF, TTPP, TOI, PCS, etc.
- The trial produced no clinically meaningful results and thus was terminated.
The molecularly unselected patients with mCRPC treated with a prior next-generation hormonal agent (NHA) and docetaxel in phase 3, randomized KEYLYNK-010 trial of pembro + ola vs. NHA abiraterone acetate (abi) or enzalutamide (enza) did not substantially improve rPFS or OS. After the second predetermined interim analysis, the research was deemed futile and terminated. In KEYLYNK-010, the PROs for pembro + ola vs. NHA are given.
Participants were randomly allocated 2:1 to receive either NHA (either enza 160 mg orally QD if the patient previously received enza) or abi 1000 mg orally QD if they had previously received enza. PROs were assessed in patients with only one PRO evaluation and one dose of study treatment.
FACT-P and BPI-SF were given at baseline, every 3 weeks until week 24, and every 6 weeks after that for about 2 years. The secondary end goal included Time to Pain Progression (TTPP), based on BPI-SF, time to deterioration (TTD), and overall improvement rate in FACT-P total and subscale scores, was among the prespecified exploratory endpoints. Using 2-sided nominal P values without controlling for duplication, differences were assessed.
793 points were distributed arbitrarily between the groups of pembro + ola (n = 529) and NHA (n = 264). In 2022, the usual follow-up was 18.7 months as of January 18. (range, 6.1-31.7). At baseline and week 15, the completion rates for the FACT-P and BPI-SF were >84% and >57%, respectively, in all assigned participants. The median TTPP for pembro + ola (13.5 mo [95% CI, 9.7-NR]) vs NHA (12.0 mo [95% CI, 10.1-NR]; HR, 0.95 [0.72-1.26]) did not vary from one another. FACT-P total scores (pembro + ola, -4.62 [95% CI, -6.47 to -2.77] vs NHA, -5.86 [95% CI, -8.58 to -3.13]) and BPI-SF scores did not vary according to LSM (Table).
The TTD FACT-P total, FACT-G total, TOI, FAPSI-6, FWB, PWB, and PCS scores did not vary between groups. For pembro + ola (44.0%) vs. NHA (39.0%), a numerically greater percentage of points had improved + stable FACT-P total scores. Scores for the FACT-P and BPI-SF remained largely constant up until wk 81 in all examined time points.
With either pembro + ola or NHA, no clinically significant differences from baseline were found in the HRQoL or disease-related symptom scores. At all analyzed time points, PRO scores between pembro + ola and NHA were usually comparable, indicating that HRQoL was maintained in heavily pretreated participants receiving pembro + ola.
Source: https://meetings.asco.org/abstracts-presentations/217134
Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT03834519
Mehra, N., Antonarakis, E. S., Park, S. H., Goh, J. C., McDermott, R. S., González, N. S., Fong, P. C. C., Greil, R., Santis, M., D., Yanez, P. E., Huang, Y. H., Begbie, S., Rey, F., Kramer, G., Suzuki, H., Saretsky, T. L., Ghate, S. R., Cui, Y., Kim, J. & Yu, E. Y. (2023). J Clin Oncol 41, 2023 (suppl 6; abstr 131) DOI: 10.1200/JCO.2023.41.6_suppl.131
