CHICAGO, USA—Combining the antibody-drug conjugate sacituzumab govitecan with pembrolizumab immunotherapy for patients with metastatic triple-negative breast cancers testing positive for the programmed death-ligand 1 (PD-L1) led to significant delays of disease progression after subsequent therapy in comparison with standard of care using a combination of chemotherapy with pembrolizumab. That’s according to first author of research reported at the 2026 American Association of Clinical Oncology Annual Meeting Kevin Kalinsky MD, Division Director of Breast Medical Oncology from Emory University at the Winship Cancer Institute, Hematology and Medical Oncology, in Atlanta, USA. He told reporter Peter Goodwin more about the details.
ASCO 2026 Audio Journal of Oncology
ASCENT-04 Study Finds Sacituzumab Govitecan plus Pembrolizumab Helps Patients with Previously Untreated Metastatic PD-L1 Positive Triple Negative Breast Cancer Live Longer Without Progression Beyond Subsequent Therapies
An interview with:
Kevin Kalinsky MD, Division Director of Breast Medical Oncology, Emory University at Winship Cancer Institute, Hematology and Medical Oncology, Atlanta, USA
CHICAGO, USA—Combining the antibody-drug conjugate sacituzumab govitecan with pembrolizumab immunotherapy for patients with metastatic triple-negative breast cancers testing positive for the programmed death-ligand 1 (PD-L1) led to significant delays of disease progression after subsequent therapy in comparison with standard of care using a combination of chemotherapy with pembrolizumab.
That’s according to first author of research reported at the 2026 American Association of Clinical Oncology Annual Meeting by Kevin Kalinsky MD, Division Director of Breast Medical Oncology from Emory University at the Winship Cancer Institute, Hematology and Medical Oncology, in Atlanta, USA. He told reporter Peter Goodwin more about the details:
AUDIO JOURNAL OF ONCOLOGY: Kavin Kalinsky MD
IN: [GOODWIN]”Peter Goodwin here, reporting from the American ….…..
OUT: ……….for the Audio Journal of Oncology, I’m Peter Goodwin.” 7:53 secs
Abstract
ASCO 2026 LBA 1000
Progression-free survival after next line of treatment (PFS2) and subsequent therapies (subs tx) in the ASCENT-04 study of participants (pts) with previously untreated PD-L1+ metastatic triple-negative breast cancer (mTNBC) treated with sacituzumab govitecan (SG) plus pembrolizumab (pembro) vs chemotherapy (chemo) plus pembro.
Background:
In ASCENT-04, first-line (1L) SG + pembro led to a statistically significant and clinically meaningful improvement in PFS vs chemo + pembro (median, 11.2 vs 7.8 mo; hazard ratio [HR], 0.65; 95% CI, 0.51-0.84; P < .001) in pts with previously untreated PD-L1+ mTNBC. Overall survival (OS) data are immature. PFS2 is more strongly associated with OS than PFS and can be used to measure long-term clinical benefit in the absence of mature OS data or when OS may be impacted by crossover. We report PFS2 and subs tx from ASCENT-04.
Methods:
Pts (N = 443) were randomized 1:1 to SG (10 mg/kg IV, days 1 & 8) + pembro (200 mg, day 1, max 35 cycles) in 21-day cycles or chemo (gemcitabine + carboplatin, paclitaxel, or nab-paclitaxel) + pembro; the primary end point was PFS by blinded independent central review (BICR). Eligible pts in the chemo + pembro group could receive 2L SG provided on study via crossover following BICR-verified progressive disease (PD) or in any subs line commercially; other subs txs per local practice were also permitted. PFS2 was defined as the time from randomization to first documented PD on next-line therapy per investigator assessment or death due to any cause, whichever occurred first.
Results:
Median follow-up for OS was 14.0 mo; 95 (43%) pts remained on study tx in the SG + pembro group (n = 221) and 52 (23%) in the chemo + pembro group (n = 222). Of the 125 pts in the SG + pembro group who discontinued tx, 69 received any subs tx, the most frequent of which were taxanes (42%), platinum chemo (33%), and capecitabine (33%). Of the 170 pts in the chemo + pembro group who discontinued tx, 119 received any subs tx, the most frequent of which were SG (81%), taxanes (9%), and capecitabine (9%). Median PFS2 and PFS2 rates are in the Table. Median (95% CI) time to first subs tx was 17.3 mo (12.7-not reached [NR]) for SG + pembro and 9.8 mo (8.7-10.9) for chemo + pembro; median (95% CI) time to second subs tx was NR (22.9 mo-NR) and 21.0 mo (16.6-NR).
Conclusions:
PFS2 was improved in the SG + pembro group vs chemo + pembro group despite crossover tx, with most pts who initiated subs tx in the chemo + pembro group receiving SG. In pts with previously untreated PD-L1+ mTNBC, SG + pembro provided clinically relevant continued benefit beyond first progression, further supporting SG + pembro as a potential new standard of care.
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