Merck KEYTRUDA improves PFS vs platinum chemotherapy in dMMR endometrial cancer (Phase 3)
- KEYNOTE‑C93 Phase 3 trial: KEYTRUDA met the primary endpoint of progression‑free survival (PFS) in dMMR advanced or recurrent endometrial cancer for patients who were chemo‑naive or recurred >6 months after adjuvant therapy.
- KEYTRUDA is the first and only PD‑1 inhibitor in a Phase 3 trial to show a statistically significant and clinically meaningful PFS improvement versus platinum doublet chemotherapy as frontline monotherapy in this population.
- Interim independent Data Monitoring Committee analysis showed a trend toward improved overall survival (OS), but OS data were immature; the trial is ongoing and OS will be evaluated at a future analysis.
- The analysis reported clinically meaningful overall response rate (ORR), complete response rate (CRR) and duration of response (DOR); safety was consistent with prior studies and no new safety signals were identified. Results will be presented and shared with regulators.
Phase 3 result
The KEYNOTE‑C93 Phase 3 trial found KEYTRUDA (pembrolizumab) monotherapy met its primary endpoint of progression‑free survival (PFS) for patients with mismatch repair deficient (dMMR) advanced or recurrent endometrial cancer who had not previously received systemic chemotherapy or who experienced recurrence more than six months after completing prior adjuvant therapy.
Comparator and significance
In this frontline setting, KEYTRUDA was the first and only PD‑1 inhibitor in a Phase 3 trial to demonstrate a statistically significant and clinically meaningful improvement in PFS compared with platinum doublet chemotherapy when given as monotherapy.
Survival, responses and safety
An independent Data Monitoring Committee's pre‑specified interim analysis observed a trend toward improvement in overall survival (OS), but the OS data were not mature at the time of the analysis; the trial continues and OS for the full study population will be evaluated in a future analysis. The interim analysis also showed clinically meaningful overall response rate (ORR), complete response rate (CRR) and duration of response (DOR). The safety profile was consistent with previously reported studies and no new safety signals were identified.
Next steps
Results will be presented at an upcoming medical meeting and shared with regulatory authorities.
Source: Merck
