Onco-Summaries: Daily Oncology Updates at a Glance
- Oncofocus Team
- Jun 26
- 3 min read
24/06/2026
US FDA approved sacituzumab govitecan-hziy as monotherapy and in combination with pembrolizumab for first-line treatment of triple-negative breast cancer (TNBC) (Ref)
Gilead Sciences announced that the US FDA approved sacituzumab govitecan-hziy (Trodelvy; Trop-2-directed ADC) for two first-line indications in unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC)
The first is, sacituzumab govitecan a single agent for the first-line treatment of unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who are not candidates for PD-1 or PD-L1 inhibitor-based therapy
The second is, sacituzumab govitecan in combination with pembrolizumab (Keytruda) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex) for the first-line treatment of unresectable locally advanced or mTNBC whose tumors express PD-L1 (CPS ≥10) as determined by an FDA-authorized test
The approval was supported by two Phase 3 trials:
ASCENT-03/NCT05382299 randomized previously untreated advanced TNBC pts who were PD-(L)1-ineligible, to sacituzumab govitecan vs treatment of physician's choice (TPC) chemotherapy (Ref; Ref)
The primary endpoint, PFS by blinded independent central review, was met: median PFS was 9.7 mos (95% CI 8.1-11.1) vs 6.9 mos (95% CI 5.6-8.2) - HR: 0.62; P<0.001
ORR: 48.0% (95% CI, 42 to 54) vs 46.0% (95% CI, 40 to 52)
Median DOR: 12.2 mos vs 7.2 mos
mOS: 21.5 mos (95% CI, 17.7-NR) vs 20.2 (95% CI, 18.2-NR) - HR 0.98 - At the time of primary analysis, overall survival was immature
Gr ≥3 TRAEs: 61.0% vs 53.0%
ASCENT-04/NCT05382286 randomized previously untreated, PD-L1–positive, advanced TNBC pts to sacituzumab govitecan + pembrolizumab vs TPC chemotherapy + pembrolizumab (Ref)
Sacituzumab govitecan + pembrolizumab led to significantly longer PFS vs chemotherapy + pembrolizumab - median PFS was 11.2 mos (95% CI, 9.3 to 16.7) vs 7.8 mos (95% CI, 7.3 to 9.3) - HR: 0.65; two-sided P<0.001
ORR: 60.0% (95% CI, 53 to 66) vs 53.0% (95% CI, 46 to 60)
Median DOR: 16.5 mos (95% CI, 12.7 to 19.5) vs 9.2 mos (95% CI, 7.6 to 11.3)
Data for overall survival were immature
Gr ≥3 AEs: 71.0% vs 70.0%
The National Comprehensive Cancer Network (NCCN) now recommends sacituzumab govitecan with or without pembrolizumab as a "Category 1" preferred first-line treatment option for pts with mTNBC across PD-L1 status. Sacituzumab govitecan already holds "category 1" recommendation in second-line mTNBC and in pre-treated HR+/HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) metastatic breast cancer (mBC)
EU approves KEYTRUDA + Padcev as first PD-1 + ADC perioperative regimen for cisplatin-ineligible MIBC (Ref)
Merck & Co/MSD announced that the European Commission has granted marketing authorization for KEYTRUDA (pembrolizumab; anti-PD-1) in combination with Padcev (enfortumab vedotin-ejfv; Nectin-4 ADC) as a perioperative treatment for cisplatin-ineligible adults with resectable muscle-invasive bladder cancer (MIBC)
Approval is supported by the pivotal Phase 3 KEYNOTE-905/EV-303 trial, in which the KEYTRUDA + Padcev perioperative regimen demonstrated a 60% reduction in event-free survival (EFS) events and a 50% reduction in risk of death compared to surgery alone
IBRANCE secures US FDA approval as the first CDK4/6 inhibitor for HR+, HER2+ metastatic breast cancer maintenance (Ref)
Pfizer's IBRANCE® (palbociclib; CDK 4/6 inhibitor) has been approved in the US for use with trastuzumab (± pertuzumab) and endocrine therapy as frontline maintenance treatment for HR+, HER2+ locally advanced or metastatic breast cancer following induction therapy
Approval is based on the Phase 3 PATINA trial, which showed a 24% reduction in risk of progression or death when IBRANCE was added to anti-HER2 and endocrine therapies compared to those therapies alone (HR: 0.76; p=0.0134)
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