Sac-TMT/Pembrolizumab Elicits Antitumor Activity in Recurrent Cervical Cancer

Results from the phase 2 2870-002/SKB264-II-06 study (NCT05642780) shared at the 2026 Society of Gynecologic Oncology Annual Meeting on Women’s Cancer demonstrated that sacituzumab tirumotecan (Sac-TMT) plus pembrolizumab (Keytruda) elicited durable responses among patients with recurrent/metastatic cervical cancer.¹

Patients who received the combination across dose levels (n = 68) achieved an overall response rate (ORR) of 51% (95% CI, 39%-64%), including a complete response (CR) of 6%. The confirmed ORR was 40% (95% CI, 28%-52%). Notably, among patients who received prior immunotherapy (n = 35) the ORR was 54% (95% CI, 37%-71%).

“With long-term follow-up, Sac-TMT plus pembrolizumab demonstrated promising and durable antitumor activity across dose groups,” Xiaohua Wu, MD, PhD, chief physician, professor, and supervisor of oncology, as well as the chairman and chief expert in gynecologic oncology at Fudan University Shanghai Cancer Center in China, said during the presentation. “An encouraging response was also observed in the IO-treated population.”

How was the 2870-002/SKB264-II-06 trial designed?

The 2870-002/SKB264-II-06 study enrolled adult patients with histologically or cytologically confirmed recurrent/metastatic cervical cancer with squamous cell, adenocarcinoma, or adenosquamous histology. Patients were required to have experienced disease progression during or after treatment with platinum-based doublet chemotherapy. Other key inclusion criteria included having received 1 or 2 prior systemic therapy regimens, measurable lesions per RECIST 1.1 criteria, and an ECOG performance status of 0 or 1.

All patients received intravenous (IV) Sac-TMT at 3 mg/kg, 4 mg/kg, or 5 mg/kg every 2 weeks. Patients also received IV pembrolizumab at 400 mg every 6 weeks.

The primary end points were safety and ORR per RECIST 1.1 criteria per investigator assessment. Secondary end points included investigator-assessed disease control rate (DCR), duration of response (DOR), and progression-free survival (PFS) per RECIST 1.1 criteria, as well as overall survival (OS).

At baseline, the median age in the overall population (n = 68) was 52 years (range, 31-72). Most patients had an ECOG performance status of 0 (57%), squamous histology (72%), recurrent and metastatic disease (88%), received 1 prior line of therapy (51%), received prior immunotherapy (51%), and received prior bevacizumab (57%). PD-L1 combined positive scores consisted of less than 1 (37%), at least 1 (47%), and unknown (16%).

What were the additional efficacy and safety data that were presented?

Additional findings from the study demonstrated that the median PFS and OS values in the overall population were 7.3 months (95% CI, 5.6-10.3) and 18.9 months (95% CI, 15.7-not evaluable). The median DOR among patients with a confirmed response was not reached (range, 1.9-25.4+). The DCR was 90% comprised of CRs (6%), partial responses (46%), stable disease (38%), progressive disease (9%), and not available data (1%).

In the safety-evaluable population (n = 68), treatment-related adverse effects (TRAEs) were reported in 100% of patients. Grade 3 or 4 TRAEs (57%), serious TRAEs (21%), TRAEs leading to dose reduction (38%), TRAEs leading to dose interruption (54%), and TRAEs leading to treatment discontinuation (3%) also occurred. Notably, no TRAEs leading to death were reported.

The median treatment durations of Sac-TMT and pembrolizumab were 6.0 months (range, 0.5-28.1) and 5.5 months (range, 0.03-24.2), respectively. The most common grade 3 or 4 adverse effects (AEs) included anemia, decreased neutrophil count, and decreased white blood cell count. Notably, no patients experienced febrile neutropenia and only 1 patient had grade 2 interstitial lung disease. All ocular surface AEs were grade 1 or 2 in severity; 6% of patients had dry eye and 1 patient each had acquired dacryostenosis, conjunctival suffusion, keratitis, and xerophthalmia.

“The global phase 3 study TroFuse-036/GOG-3123/ENGOT-cx22 [NCT07216703] is investigating Sac-TMT plus pembrolizumab with/without bevacizumab [Avastin] as first-line maintenance therapy in participants with cervical cancer,” Wu said during his conclusion.²

Disclosures: Wu noted that he had no financial relationships with ACCME-defined ineligible companies to report. Wu received study funding from Sichuan Kelun-Bioteach Biopharmaceutical Co. Ltd. And Merch Sharp & Dohme LLC. Medical writing and editorial assistance were provided by Tina Nie, PhD, of ICON plc; this assistance was funded by MSD.

References

1. Wu X, Wang J, An R, et al. Sacituzumab tirumotecan (Sac-TMT) plus pembrolizumab in participants with recurrent or metastatic cervical cancer: results from the phase 2 2870-002/SKB264-II-06 study. Presented at: 2026 SGO Annual Meeting; April 10-13, 2025; San Juan, Puerto Rico.
2. A clinical study of sacituzumab tirumotecan (MK-2870) in combination with pembrolizumab (MK-3475) as first-line maintenance treatment of cervical cancer (MK-2870-036/​TroFuse-036/​GOG-3123/​ENGOT-cx22). ClinicalTrials.gov. Updated April 9, 2026. Accessed April 13, 2026. https://clinicaltrials.gov/study/NCT07216703