Trodelvy (sacituzumab govitecan-hziy) / Gilead - LARVOL DELTA

Sacituzumab govitecan (SG) + pembrolizumab (pembro) vs chemotherapy (chemo) + pembro in previously untreated PD-L1–positive advanced triple-negative breast cancer (TNBC): Primary results from the randomized phase 3 ASCENT-04/KEYNOTE-D19 study. (ASCO 2025) - P3 | " Patients were randomized 1:1 to SG (10 mg/kg IV, day 1 & 8) + pembro (200 mg, day 1, max 35 cycles) in 21-day cycles or chemo (gemcitabine + carboplatin, paclitaxel, nab-paclitaxel) + pembro until disease progression or unacceptable toxicity. SG + pembro led to a statistically significant and clinically meaningful improvement in PFS vs chemo + pembro with durable responses, no new safety concerns for SG or pembro, and a lower rate of treatment discontinuation due to TEAEs in patients with previously untreated, PD-L1–positive advanced TNBC. These data support the use of SG + pembro as a potential new standard of care treatment in this patient population."

Clinical • Late-breaking abstract • Metastases • P3 data • Anemia • Breast Cancer • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia • Triple Negative Breast Cancer • PD-L1

Primary results from ASCENT-03: A randomized phase III study of sacituzumab govitecan (SG) vs chemotherapy (chemo) in patients (pts) with previously untreated advanced triple-negative breast cancer (TNBC) who are unable to receive PD-(L)1 inhibitors (PD-[L]1i) (ESMO 2025) - P3 | "Background Significant PFS benefit was observed with SG vs chemo in pretreated metastatic (m)TNBC (ASCENT) and with SG + pembrolizumab vs chemo + pembrolizumab in first-line (1L) PD-L1+ mTNBC (ASCENT-04)...Randomization (1:1) to SG (10 mg/kg IV, days 1 & 8 in 21-day cycles) or chemo (paclitaxel, nab-paclitaxel, or gemcitabine + carboplatin) was stratified by disease status and geography...These data support SG as a potential new standard of care for pts with previously untreated mTNBC who are unable to receive a PD-(L)1i. Table: LBA20 Efficacy: Intent-to-treat SG (n = 279) Chemo (n = 279) Median PFS per BICR (95% CI), mo 9.7 (8.2-11.1) 6.9 (5.6-8.3) HR (95% CI); adjusted two-sided P -value 0.62 (0.50-0.78); P < .0001 ORR (95% CI), % 48.4 (42.4-54.4) 45.5 (39.6-51.6) Median DOR (95% CI), mo 12.2 (9.7-13.8) 7.2 (5.7-8.4) Safety: All treated n = 275 n = 276 TEAEs, n (%) Any grade Grade ≥ 3 Led to dose reduction Led to treatment discontinuation 273 (99) 181 (66)..."

Clinical • Late-breaking abstract • Metastases • P3 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • PD-L1

Sacituzumab govitecan vs chemotherapy as first therapy after endocrine therapy in HR+/HER2− (IHC 0, 1+, 2+/ISH−) metastatic breast cancer: Primary results from ASCENT-07 (SABCS 2025) - P3 | " Participants were randomized 2:1 to receive SG 10 mg/kg IV or chemotherapy treatment of physician's choice (TPC; capecitabine, nab-paclitaxel, or paclitaxel). The study did not meet the primary endpoint of PFS by BICR in participants with HR+/HER2−, locally advanced unresectable or mBC who have received prior ET and are candidates for first chemotherapy. No new safety concerns were identified. An early trend in improvement of OS was observed, and the study will continue to further assess OS."

Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

Safety analysis of phase 3 ASCENT-04 study of sacituzumab govitecan (SG) + pembrolizumab (pembro) vs chemotherapy (chemo) + pembro for previously untreated PD-L1+ metastatic triple-negative breast cancer (mTNBC) (SABCS 2025) - "In pts with previously untreated PD-L1+ mTNBC, EAIRs were generally similar between tx arms. With SG + pembro, there was a lower rate of TEAEs leading to dose reduction or discontinuation and a higher rate of any TEAEs; the rate of imAEs was lower vs chemo + pembro, although diarrhea and colitis were higher. Neutropenia, diarrhea, and colitis were manageable with supportive care."

Clinical • Metastases • P3 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • PD-L1

Sacituzumab govitecan in combination with capecitabine for the treatment of advanced gastrointestinal cancers after progression on standard therapy. (ASCO-GI 2026) - P1 | "SG is covalently bound to the topoisomerase I inhibitor SN-38, which is the active metabolite of irinotecan. The trial will enroll up to 20 patients. The trial is funded by Gilead Sciences, Inc."

Combination therapy • Metastases • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • TACSTD2

Real-world use and survival outcomes of sacituzumab govitecan in metastatic triple-negative breast cancer and hormone receptor-positive/HER2-negative metastatic breast cancer. (PubMed, Br J Cancer) - "The study highlights SG's clinical relevance and the challenge of translating trial efficacy into real-world outcomes, reinforcing the need for further investigation of tolerability in broader populations."

Journal • Real-world evidence • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Respiratory Diseases • Solid Tumor • Triple Negative Breast Cancer • HER-2

Phase 2 EVOKE-02 Study of Sacituzumab Govitecan and Pembrolizumab±Platinum in First-Line Metastatic NSCLC (IASLC-WCLC 2022) - P1/2, P2 | "We hypothesize that combining SG with pembrolizumab or with pembrolizumab + platinum chemotherapy will improve outcomes for patients with advanced NSCLC. EVOKE-02 (NCT05186974) is an open-label, multicenter, multicohort, global phase 2 study evaluating SG plus pembrolizumab with or without carboplatin (carbo) or cisplatin (cis) in advanced NSCLC. Reused with permission. This abstract was accepted and previously presented at the 2022 ASCO Annual Meeting."

Clinical • IO biomarker • P2 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Case of Multiple Liver Metastases from Breast Cancer Treated with Sacituzumab Govitecan Using a Scalp Cooling System (PubMed, Gan To Kagaku Ryoho) - "Although she was treated with paclitaxel(PTX)plus bevacizumab(Bev), followed by pembrolizumab(Pemb)in combination with carboplatin(CBDCA)and gemcitabine(GEM), the liver metastases showed progressive disease. The patient did not require a wig, and the scalp cooling system demonstrated a favorable hair preservation effect. Further case accumulation is necessary to evaluate the hair loss prevention effect of the scalp cooling system during sacituzumab govitecan administration."

Journal • Alopecia • Breast Cancer • Oncology • Solid Tumor

Patient-reported outcomes (PROs) with sacituzumab govitecan (SG) vs chemotherapy in patients with previously untreated advanced triple-negative breast cancer (TNBC) who are not candidates for PD-(L)1 inhibitors in the phase 3 ASCENT-03 study (SABCS 2025) - P3 | " Patients were randomized to SG or chemotherapy (gemcitabine + carboplatin, paclitaxel, nab-paclitaxel). The key secondary endpoints of LS mean changes from baseline to week 25 in physical functioning favored SG vs chemotherapy, while TTD in fatigue was similar in both treatment arms. These data, along with additional exploratory results reported here, suggest that SG was associated with more favorable and sustained benefits in QOL vs chemotherapy. The known gastrointestinal side effects of SG did not negatively impact global health status/QoL or functional domain scores in this analysis."

Clinical • Metastases • P3 data • Patient reported outcomes • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Trodelvy + Keytruda: Data from P3 EVOKE-03 trial (NCT05609968) for stage IV 1L PD-L1 high NSCLC in 2026 (Gilead, 44th Annual J.P. Morgan Healthcare Conference)

P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Trodelvy + Keytruda: Data from P3 EVOKE-03 trial (NCT05609968) for stage IV 1L PD-L1 high NSCLC in 2026 (Gilead, 44th Annual J.P. Morgan Healthcare Conference)

P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology

Signalling Pathways and Inhibitors in Triple Negative Breast Cancer: Current Progress. (PubMed, Anticancer Agents Med Chem) - "To significantly enhance outcomes for TNBC patients, future research must concentrate on identifying predictive biomarkers and refining individualized therapy plans."

IO biomarker • Journal • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

Antibody-Based Therapeutics in Breast Cancer: Clinical and Translational Perspectives. (PubMed, Antibodies (Basel)) - "Monoclonal antibodies such as trastuzumab and pertuzumab have established HER2-targeted therapy as a standard of care, while immune checkpoint inhibitors have introduced immunotherapy into the treatment of triple-negative breast cancer. The emergence of antibody-drug conjugates (ADCs), including trastuzumab deruxtecan, sacituzumab govitecan, and datopotamab deruxtecan, has further expanded the available therapeutic options...This review summarizes the biological rationale, clinical evidence, resistance mechanisms, and safety profiles of therapies based on monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates in breast cancer. The development of these treatment modalities fosters the implementation of personalized, immunologically informed treatment strategies that are redefining precision oncology in breast cancer."

Journal • Review • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Sacituzumab Govitecan plus Pembrolizumab for Advanced Triple-Negative Breast Cancer. (PubMed, N Engl J Med) - P3 | "Sacituzumab govitecan plus pembrolizumab led to significantly longer progression-free survival than chemotherapy plus pembrolizumab among patients with previously untreated, PD-L1-positive, advanced triple-negative breast cancer. (Funded by Gilead Sciences; ASCENT-04/KEYNOTE-D19 ClinicalTrials.gov number, NCT05382286.)."

Clinical • Journal • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • PD-L1

Therapeutic synergies that overcome carboplatin resistance in triple-negative breast cancer. (PubMed, J Exp Clin Cancer Res) - "Isogenic PDX models of TNBC provide a powerful platform to define molecular mechanisms of acquired carboplatin resistance and uncover actionable therapeutic strategies. Our findings reveal multiple adaptive routes to platinum resistance, including restoration of homologous recombination and activation of alternative DNA repair programs. Synergistic interactions between SG and mTOR inhibition offer a promising avenue for overcoming resistance, supporting further clinical investigation of these combinations in TNBC."

Journal • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA1 • HORMAD1

Sacituzumab Govitecan (SG) vs Treatment of Physician’s Choice (TPC): Efficacy by Trop-2 Expression in the TROPiCS-02 Study of Patients (Pts) With HR+/HER2– Metastatic Breast Cancer (mBC) (SABCS 2022) - "Pts were randomized 1:1 to receive SG (10 mg/kg IV on d 1 and 8, every 21 d) or TPC (eribulin, gemcitabine, capecitabine, or vinorelbine) until disease progression or unacceptable toxicity. In this TROPiCS-02 post-hoc analysis, improved efficacy with SG vs TPC was observed regardless of Trop-2 expression, and there was no clear level of Trop-2 expression at which a better treatment effect for SG was observed. These results support SG as an effective novel treatment option for patients with pretreated, endocrine- resistant HR+/HER2- mBC, and reinforce that Trop-2 testing is not required for SG treatment."

Clinical • Breast Cancer • HER2 Breast Cancer • Oncology • Triple Negative Breast Cancer • HER-2

Real-world outcomes of reduced-dose versus standard-dose antibody drug conjugates in metastatic breast cancer: a retrospective cohort study. (PubMed, Breast Cancer Res Treat) - "This real-world data suggest RD of SG or T-DXd achieve outcomes comparable to SD, supporting prospective evaluation of lower-dose regimens."

Journal • Real-world evidence • Retrospective data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • HER-2

SACI-IO HR+: A randomized phase II trial of sacituzumab govitecan with or without pembrolizumab in patients with metastatic hormone receptor-positive/HER2-negative breast cancer. (ASCO 2024) - P2 | "Pts who received prior topoisomerase I inhibitor ADC, irinotecan or PD-1/L1 inhibitors were excluded. Addition of pembrolizumab to SG showed a non-significant trend toward improved PFS in unselected HR+/HER2- MBC at this preliminary time point. Final PFS and updated OS with further follow-up will be presented at the meeting. Exploratory outcome analyses by TROP2 and PD-L1 expression will be reported."

Clinical • IO biomarker • Late-breaking abstract • Metastases • P2 data • Alopecia • Anemia • Breast Cancer • Fatigue • Hematological Disorders • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Immunology • Leukopenia • Neutropenia • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • STING • TACSTD2

Sacituzumab govitecan (SG) + pembrolizumab (pembro) in first-line (1L) metastatic non-small cell lung cancer (mNSCLC): Efficacy results by histology from the EVOKE-02 study (ELCC 2024) - P2 | "Conclusions In EVOKE-02, SG + pembro showed promising activity regardless of histology (squamous and nonsquamous) in previously untreated mNSCLC. The safety profile was manageable and consistent with the known safety profile of each agent."

Clinical • Metastases • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Updated efficacy profile of the double antibody drug conjugate (DAD) phase I trial: Sacituzumab govitecan (SG) plus enfortumab vedotin (EV) in ≥ second line in metastatic urothelial carcinoma (mUC) (ESMO 2024) - P1 | "Funding: Gilead. With 22 month median follow-up, SG+EV continues to show encouraging activity with an ORR of 70% with no new safety signals in ps with treatment resistant mUC. This data supports the ongoing expansion cohorts of SG 7.5 mg/kg + EV 1.25 mg/kg D1,8 every 21 days in the treatment-resistant setting and in combination with pembrolizumab as first-line therapy for mUC (NCT04724018)."

Clinical • Metastases • P1 data • Oncology • Solid Tumor • Urothelial Cancer

Real-world use and survival outcomes of sacituzumab govitecan in metastatic triple-negative breast cancer and hormone receptor-positive/HER2-negative metastatic breast cancer (Nature) - "3653 patients were included: 2527 mTNBC and 1,126 HR+/HER2– mBC, with median ages of 58 and 61.5 years. Median OS was 11.0 months (95%CI: 10.4–11.7) for mTNBC and 11.4 months (95% CI: 10.7–12.4) for HR+/HER2–mBC. One-year survival was 47% and 48% and median TTD of 4.3 and 3.5 months, respectively. Poorer OS was independently associated with inpatient SG initiation and liver/digestive metastases. In mTNBC, additional factors included brain metastases, respiratory disease, tobacco-related hospitalisation, multiple metastatic sites, and prior treatments."

Real-world • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Triple Negative Breast Cancer

Sacituzumab govitecan (SG) efficacy in hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2–) metastatic breast cancer (MBC) by HER2 immunohistochemistry (IHC) status in the phase III TROPiCS-02 study (ESMO 2022) - P3 | "Methods Pts with HR+/HER2– unresectable locally advanced or MBC and 2-4 prior chemotherapy regimens for MBC were randomized 1:1 to receive SG (10 mg/kg IV on d 1 and 8, every 21 d) or TPC (capecitabine, eribulin, vinorelbine, or gemcitabine) until unacceptable toxicity or disease progression. Conclusions Clinical benefit with SG vs TPC in HER2 IHC0 and HER2-Low HR+/HER2- MBC was consistent with that of the TROPiCS-02 ITT population. SG should be considered an effective treatment option for pts with HR+/HER2- MBC, regardless of HER2 status."

Clinical • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2

A Clinical Study on the Use of Yuyang Mouthwash for the Prevention of Grade ≥2 Sacituzumab Govitecan–Associated Oral Mucositis (ChiCTR) - P=N/A | N=303 | Not yet recruiting | Sponsor: Beijing Luhe Medical College Affiliated to Capital Medical University; Beijing Luhe Medical College Affiliated to Capital Medical University

New trial • Mucositis • Stomatitis

Perioperative sacituzumab govitecan (SG) alone or in combination with pembrolizumab (Pembro) for patients with muscle-invasive urothelial bladder cancer (MIBC): SURE-01/02 interim results. (ASCO 2024) - P2 | " Pts with cT2-4N0M0 MIBC who were ineligible for or refused cisplatin-based neoadjuvant chemotherapy were planned to receive 4 cycles of neoadjuvant SG 10 mg/kg intravenously (IV) on days 1 and 8, Q3W, followed by radical cystectomy (RC). Observed ypT0N0-x responses after neoadjuvant SG showed promising activity in MIBC who have a high unmet need, with a potential to avoid RC. Reduced dose of SG was feasible and the data support the ongoing SURE studies in MIBC."

Clinical • Combination therapy • Late-breaking abstract • Bladder Cancer • Genito-urinary Cancer • Oncology • Palliative care • Solid Tumor • Urothelial Cancer • ARID1A • BRCA1 • BRCA2 • HER-2 • UGT1A1

Correlation of TROP2 expression with outcomes of sacituzumab govitecan with or without pembrolizumab in patients with metastatic hormone receptor-positive/HER2-negative breast cancer: an exploratory analysis from the phase II SACI-IO HR+ trial (SABCS 2024) - P2 | "In this prespecified exploratory analysis of the SACI-IO HR+ trial, TROP2 expression by QIF was not associated with survival outcomes across all pts, by treatment arm or by PD-L1 status. Exploratory outcome analyses by TROP2 IHC expression and association with QIF will be reported."

Clinical • IO biomarker • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • PD-L1 • TACSTD2