Camtobell (belotecan) / Chong Kun Dang - LARVOL DELTA

Sacituzumab tirumotecan (sac-TMT) vs platinum-based chemotherapy in EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC) following progression on EGFR-TKIs: results from the randomized, multi-center phase III OptiTROP-Lung04 study (ESMO 2025) - P3 | "Background Sac-TMT is a TROP2 ADC developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor. Sac-TMT demonstrated significant survival benefits over docetaxel in EGFRm NSCLC after failure of EGFR-TKI and platinum-based chemotherapy ( Fang et al., BMJ 2025 )...Methods Patients (pts) were randomized (1:1) to receive sac-TMT monotherapy (5 mg/kg Q2W) or chemotherapy (pemetrexed 500 mg/m 2 + carboplatin AUC 5 or cisplatin 75 mg/m 2 Q3W for 4 cycles followed by maintenance of pemetrexed)...*censored at the date of initiation of subsequent anti-tumor ADC drug therapy. Conclusions Sac-TMT is the first TROP2 ADC to significantly improve PFS and OS over platinum-based chemotherapy, with manageable safety in EGFR-TKI resistant NSCLC, positioning it as a potential new standard of care for this population."

Clinical • Late-breaking abstract • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Sacituzumab tirumotecan (sac-TMT) in patients (pts) with previously treated advanced EGFR-mutated non-small cell lung cancer (NSCLC): Results from the randomized OptiTROP-Lung03 study. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT05631262 Background: Sac-TMT (MK-2870/SKB264), a novel TROP2 ADC developed to conjugate a belotecan-derivative topoisomerase I inhibitor, has shown encouraging antitumor activity in EGFRm NSCLC pts in phase Ⅰ trial (Fang et al. Sac-TMT demonstrated improved ORR, PFS and OS compared to docetaxel, with manageable safety profile in pts with previously treated advanced EGFRm NSCLC. These results highlight significant survival benefits and suggest that sac-TMT could emerge as a new standard of care for this population."

Clinical • Metastases • Anemia • Dental Disorders • Febrile Neutropenia • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Stomatitis • EGFR

Sacituzumab tirumotecan (sac-TMT) as first-line treatment for unresectable locally advanced/metastatic triple-negative breast cancer (a/mTNBC): Initial results from the phase II OptiTROP-Breast05 study. (ASCO 2025) - P2, P3 | "Sac-TMT (MK-2870/SKB264) is a TROP2 ADC developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor. Sac-TMT demonstrated promising anti-tumor activity with a manageable safety profile as a first-line treatment for pts with a/mTNBC, independent of the PD-L1 status. A Phase 3 study comparing sac-TMT vs investigator's choice of chemotherapy in first-line PD-L1-negative (CPS < 10) a/mTNBC is currently underway (NCT06279364)."

Clinical • Metastases • P2 data • Anemia • Breast Cancer • Dental Disorders • Fatigue • Interstitial Lung Disease • Oncology • Pain • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Stomatitis • Triple Negative Breast Cancer

Sacituzumab tirumotecan (sac-TMT) in combination with tagitanlimab (anti-PD-L1) in first-line (1L) advanced non-small-cell lung cancer (NSCLC): Non-squamous cohort from the phase II OptiTROP-Lung01 study. (ASCO 2025) - P2, P3 | "Clinical Trial Registration Number: NCT05351788 Background: Sac-TMT (MK-2870/SKB264) is a TROP2 ADC developed with a novel linker to conjugate a belotecan-derivative topoisomerase I inhibitor. Sac-TMT in combination with tagitanlimab demonstrated promising antitumor activity in treatment-naive advanced non-squamous NSCLC. The durable clinical activities were observed regardless of PD-L1 expression. This combination therapy showed a tolerable safety profile based on known profiles of the individual agents, with no new safety signals observed."

Clinical • Combination therapy • IO biomarker • Metastases • P2 data • Anemia • Dental Disorders • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Stomatitis

Sacituzumab tirumotecan (sac-TMT) vs investigator's choice of chemotherapy (ICC) in previously treated locally advanced or metastatic hormone receptor-positive, HER2-negative (HR+/HER2-) breast cancer (BC): Results from the randomized, multi-center phase III OptiTROP-Breast02 study (ESMO 2025) - P3 | "Background Sac-TMT is a TROP2 ADC developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor...Methods Pts with HR+/HER2- BC who had progression on CDK4/6 inhibitors and received at least one prior line of chemotherapy in the advanced/metastatic setting were randomized (1:1) to receive sac-TMT 5 mg/kg Q2W or ICC (eribulin, vinorelbine, capecitabine, or gemcitabine)...Grade ≥ 3 TRAEs occurred in 62.0% and 64.8% of pts in sac-TMT and ICC with the most common being neutrophil count decreased (44.5% vs 51.5%) and WBC decreased (31.0% vs 31.6%); TRAE led to discontinuation in 0% and 0.5% of pts; pneumonitis occurred in 1.5% and 1.0% of pts (all grade 1-2) in sac-TMT and ICC, respectively. Conclusions Sac-TMT demonstrated significantly improved PFS compared to ICC, with manageable safety profile in pts with previously treated HR+/HER2- BC including both HER2-zero and HER2-low, positioning it as a new therapeutic option for..."

Clinical • Late-breaking abstract • Metastases • 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 • HER-2

Updated ongoing phase I/II clinical trial results of AMT-116, a first-in-class anti-CD44v9 antibody-drug conjugate (ADC), in patients with advanced solid tumors (ESMO 2025) - P1, P1/2 | "AMT-116 is a first-in-class antibody-drug conjugate (ADC) comprising a humanized anti-CD44v9 IgG1 antibody conjugated to KL610023, a novel belotecan-derived topoisomerase I inhibitor, via a cleavable hydrolysable linker (average drug-to-antibody ratio: 7–8). Conclusions AMT-116 demonstrated a manageable safety profile and promising antitumor activity across solid tumors especially in EGFR wild-type NSCLC. Enrollments are ongoing to further assess efficacy in NSCLC and other potential cancer types."

Clinical • Metastases • P1/2 data • Anal Carcinoma • Head and Neck Cancer • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EGFR

TroFuse-032: A phase 3, randomized study of pembrolizumab (Pembro) + sacituzumab tirumotecan (Sac-TMT) or chemotherapy (Chemo) followed by pembro + chemo for early-stage triple-negative breast cancer (TNBC) or HR-low+/HER2− breast cancer (ESMO 2025) - P3 | "Sac-TMT (also known as MK-2870/SKB264), a novel antibody-drug conjugate composed of an anti-TROP2 antibody coupled to a cytotoxic belotecan derivative via a novel linker, has demonstrated significant PFS and OS benefits vs chemo in patients with metastatic TNBC. Enrollment is ongoing. Table: 420TiP Study Treatment Neoadjuvant Adjuvant Cycles a 1–2 Cycles a 3–4 Cycles a 5–9 Arm 1 Pembro b + sac-TMT (4 mg/kg Q2W) Pembro b + paclitaxel c + carboplatin d Pts with pCR: Pembro (400 mg Q6W or 200 mg Arm 2 Pembro b + paclitaxel c + carboplatin d Pembro b + doxorubicin e or epirubicin f + cyclophosphamide g Q3W) Pts with residual disease: Pembro (400 mg Q6W or 200 mg Q3W) + optional treatment of physician's choice (olaparib h , capecitabine i or doxorubicin j,k or epirubicin l,k + cyclophosphamide m,k ) a Cycle length = 6 wks; b 200 mg Q3W; c 80 mg/m2QW; d AUC 1.5 QW; e 60 mg/m2Q3W; f 90 mg/m2Q3W; g 600 mg/m2Q3W; h 100 or 150 mg every 2 wks; i 1000 to 1250 mg/m2every 2..."

Clinical • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • HER-2 • TACSTD2

SKB264 (MK-2870) in previously treated hormone receptor-positive (HR+)/ HER2-negative metastatic breast cancer (mBC): Results from a phase I/II, single-arm, basket trial (ESMO 2023) - P1/2 | "SKB264 is a novel anti-TROP2 ADC developed using sulfonyl pyrimidine-CL2A-carbonate linker to conjugate its payload, a belotecan-derivative topoisomerase I inhibitor, to achieve an average Drug-to-antibody Ratio (DAR) of 7.4. Conclusions SKB264 at 5 mg/kg demonstrates a manageable safety profile and promising antitumor activity in pts with pre-treated HR+/HER2- mBC. Two phase 3 studies are currently planned in HR+/HER2- mBC, one in China for pts after at least one chemo for mBC and a second global for pts previously untreated with chemo for mBC, both comparing SKB264 vs investigator selected chemo."

Metastases • P1/2 data • Pan tumor • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2 • TACSTD2

Sacituzumab tirumotecan (SKB264/MK-2870) in combination with KL-A167 (anti-PD-L1) as first-line treatment for patients with advanced NSCLC from the phase II OptiTROP-Lung01 study. (ASCO 2024) - P2, P3 | "Background: Sacituzumab Tirumotecan (SKB264/MK-2870)is a TROP2 ADC developed with novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor. SKB264 in combination with KL-A167 demonstrated promising efficacy results in treatment naive advanced NSCLC with manageable safety profile. SKB264 Q2W was recommended for further investigation. A Phase 3 study of SKB264 Q2W plus pembrolizumab vs pembrolizumab in 1L metastatic NSCLC with PD-L1 TPS ≥ 50% (NCT06170788) is ongoing."

Clinical • Combination therapy • IO biomarker • Metastases • P2 data • Anemia • Hematological Disorders • Immunology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Sacituzumab tirumotecan (SKB264/MK-2870) in patients (pts) with previously treated locally recurrent or metastatic triple-negative breast cancer (TNBC): Results from the phase III OptiTROP-Breast01 study. (ASCO 2024) - P3 | "Sacituzumab tirumotecan (SKB264/MK-2870) is a TROP2 ADC developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4... In this randomized phase Ⅲ trial, SKB264 was compared with physician's choice of chemotherapy (eribulin, vinorelbine, capecitabine, or gemcitabine) in pts with locally recurrent or metastatic TNBC who had received two or more prior therapies including at least one for metastatic setting... Sacituzumab tirumotecan monotherapy demonstrated statistically significant and clinically meaningful PFS and OS benefit over chemotherapy, with a manageable safety profile in pts with heavily pretreated advanced TNBC and limited treatment options."

Clinical • IO biomarker • Metastases • P3 data • Anemia • Breast Cancer • Hematological Disorders • Oncology • Solid Tumor • Triple Negative Breast Cancer • TACSTD2

Preliminary results from a first-in-human trial of AMT-116, a topoisomerase I inhibitor containing antibody-drug conjugate (ADC), in patients with advanced solid tumors. (ASCO 2024) - P1 | "AMT-116 is a first-in-class antibody-drug conjugate (ADC) targeting CD44v9, by conjugating a novel topoisomerase I inhibitor, belotecan derivative named KL610023 (Sichuan Kelun-Biotech) to a humanized anti-CD44v9 immunoglobulin G1 (IgG1) antibody via a hydrolysable linker with an average drug-to-antibody ratio of 7-8. These preliminary data indicate that AMT-116 is well tolerated at the first two dose levels in patients with heavily pretreated advanced solid tumors. Dose escalation is ongoing. Clinical trial information: NCT05725291."

Clinical • Metastases • P1 data • Anal Carcinoma • Cervical Cancer • Fatigue • Gastric Cancer • Gastrointestinal Cancer • Hematological Disorders • Hepatocellular Cancer • Leukopenia • Oncology • Solid Tumor • Squamous Cell Carcinoma

Efficacy and safety of sacituzumab tirumotecan (sac-TMT) plus pembrolizumab in patients with recurrent or metastatic cervical cancer (ESMO 2024) - P2 | "Sac-TMT (also known as MK-2870/ SKB264) is a TROP2 ADC developed with novel linker to conjugate a belotecan-derivative topoisomerase I inhibitor...47.4% had received two prior lines of therapy, 52.6% had received bevacizumab, and 42.1% had received anti-PD-1 based therapy... Sac-TMT plus pembrolizumab demonstrated promising and durable antitumor activity with manageable safety profile. No new safety signal was observed. Considering the activity of this combination among pts who were pre-treated with anti-PD-1 based therapy, further investigation is warranted."

Clinical • Metastases • Cervical Cancer • Oncology • Solid Tumor

Safety and efficacy of sacituzumab tirumotecan (sac-TMT) in patients (pts) with previously treated advanced endometrial carcinoma (EC) and ovarian cancer (OC) from a phase II study (ESMO 2024) - P1/2 | "Sac-TMT (also known as MK-2870/SKB264) is a TROP2 ADC developed with a hydrolytically cleavable linker to conjugate a belotecan-derivative topoisomerase I inhibitor. Sac-TMT monotherapy has shown promising anti-tumor activity with a manageable safety profile in pts with heavily pre-treated advanced EC and OC."

Clinical • Metastases • P2 data • Endometrial Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • TACSTD2

Trofuse-032: a phase 3, randomized study of pembrolizumab plus sacituzumab tirumotecan or chemotherapy followed by pembrolizumab plus chemotherapy for early-stage triple-negative breast cancer or hormone receptor-low-positive (HR-low+)/ human epidermal growth factor receptor 2-negative (HER2−) breast cancer (SABCS 2025) - P3 | "Sacituzumab tirumotecan or sac-TMT (also known as MK-2870/SKB264), a novel antibody-drug conjugate composed of an anti-TROP2 antibody coupled to a cytotoxic belotecan derivative via a novel linker, has demonstrated significant PFS and OS benefits vs chemo in patients with metastatic TNBC...Participants are randomized 1:1 to neoadjuvant pembro plus sac-TMT followed by pembro plus paclitaxel plus carboplatin (arm 1) vs pembro plus paclitaxel plus carboplatin followed by pembro plus doxorubicin or epirubicin plus cyclophosphamide (arm 2; Table)...Secondary endpoints include OS, pCR-no DCIS (ypT0 ypN0), distant progression- or distant recurrence-free survival, patient-reported outcomes, and safety. Enrollment is ongoing."

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 • TACSTD2

Trofuse-012: a phase 3, randomized study of adjuvant sacituzumab tirumotecan plus pembrolizumab vs treatment of physician's choice in participants with triple-negative breast cancer who received neoadjuvant therapy and did not achieve a pathological complete response at surgery (SABCS 2025) - P3 | "Sacituzumab tirumotecan (sac-TMT; also known as MK-2870/SKB264) is a novel antibody-drug conjugate composed of anti-TROP2 antibody coupled to a cytotoxic belotecan derivative via a novel linker (average drug/antibody ratio, 7.4)...This study (NCT06393374) evaluates adjuvant sac-TMT plus pembrolizumab vs treatment of physician's choice (TPC; pembrolizumab ± capecitabine) in participants with TNBC who received neoadjuvant therapy and did not achieve pCR at surgery. This phase 3, multicenter, open-label study is enrolling participants ≥18 years old with centrally confirmed TNBC per most recent American Society of Clinical Oncology/College of American Pathologists guidelines...Secondary endpoints are OS, distant recurrence-free survival, patient-reported outcomes, and safety. Enrollment began Q2 2024."

Clinical • P3 data • Surgery • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • TACSTD2

Trofuse-011: a phase 3, randomized, open-label study of sacituzumab tirumotecan with or without pembrolizumab vs treatment of physician's choice for previously untreated locally recurrent unresectable or metastatic triple-negative breast cancer (SABCS 2025) - P3 | "Sacituzumab tirumotecan (sac-TMT; MK-2870/SKB264) is a novel antibody-drug conjugate (ADC) composed of an anti-trophoblast cell surface antigen 2 (TROP2) monoclonal antibody coupled to a cytotoxic belotecan derivative, topoisomerase I inhibitor payload via a novel linker. Tumor imaging occurs at baseline, Q8W after randomization until week 48, and Q12W thereafter. Enrollment is ongoing."

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

Sacituzumab tirumotecan (sac-TMT) + pembrolizumab (pembro) for treatment-naïve advanced PD-L1-positive NSCLC: Results from the phase II MK-2870-003/SKB264-II-04 study (ESMO 2025) - P2, P3 | "Background Sac-TMT (MK-2870/SKB264) is an anti‒TROP2 ADC with a hydrolytically cleavable linker and belotecan-derivative topoisomerase I inhibitor payload...Sac-TMT combined with tagitanlimab (anti-PD-L1, KL-A167) showed promising clinical activity in the first-line treatment of NSCLC (Fang et al., ASCO, 2025)...Conclusions Sac-TMT + pembro had manageable safety and promising antitumor activity in pts with treatment-naïve advanced or metastatic PD-L1-positive NSCLC. Ongoing phase III studies are evaluating sac-TMT + pembro vs pembro as first-line treatment for pts with advanced NSCLC (SKB264-III-12 [TPS ≥1%], NCT06448312; MK-2870-007 [TPS ≥50%], NCT06170788)."

IO biomarker • Metastases • P2 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

TroFuse-011: A phase 3, randomized, open-label study of sacituzumab tirumotecan (sac-TMT) ± pembrolizumab (Pembro) vs treatment of physician's choice (TPC) for previously untreated locally recurrent, unresectable, or metastatic triple-negative breast cancer (TNBC) (ESMO 2025) - P3 | "Sac-TMT (MK-2870/SKB264) is a novel ADC composed of an anti–trophoblast cell surface antigen 2 (anti-TROP2) monoclonal antibody coupled to a cytotoxic belotecan derivative, topoisomerase I inhibitor payload via a novel linker...Table: 622TiP Intervention Arm A sac-TMT a Arm B sac-TMT a + pembro b Arm C Paclitaxel c or nab-paclitaxel d or gemcitabine e + carboplatin f a 4 mg/kg Q2W...e 1000 mg/m 2 on days 1 and 8, Q3W. f AUC 2 mg/mL/min on days 1 and 8, Q3W."

Clinical • IO biomarker • Metastases • P3 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • PD-L1 • TACSTD2

Safety of 4 mg/kg and 5 mg/kg doses of sacituzumab tirumotecan (sac-TMT) in unresectable locally advanced/metastatic solid tumors: 2870-001/KL264-01 study (AACR-NCI-EORTC 2025) - P1/2 | "Background: sac-TMT (MK-2870/SKB264) is an antibody-drug conjugate comprising a humanized anti-TROP2 monoclonal antibody, a unique bifunctional linker, and a novel belotecan-derived topoisomerase I inhibitor payload. While sac-TMT 4 mg/kg showed lower frequencies of hematologic toxicity and stomatitis, both sac-TMT doses had manageable safety profiles with routine medical care and dose modification in pts with unresectable locally advanced or metastatic solid tumors. Discontinuation rates for both doses were low."

Clinical • Late-breaking abstract • Metastases • Oncology • Solid Tumor

Sacituzumab tirumotecan (sac-TMT) in participants (pts) with previously treated, advanced KRAS-mutant NSCLC: Results from cohort 5d of the SKB264-II-08 study (ESMO 2025) - P2 | "Background Sac-TMT (SKB264/MK-2870) is a TROP2-directed ADC with a hydrolytically cleavable linker and belotecan-derivative topoisomerase I inhibitor payload. The OptiTROP-Lung03 study demonstrated significant survival benefits with sac-TMT compared to docetaxel in pts with EGFR -mutant NSCLC following the progression on EGFR-TKI and platinum-based chemotherapy (chemo) [Zhang et al...Table: 1945P Endpoint Sac-TMT (N = 16) Confirmed ORR, n (%) 4 (25) CR 0 (0) PR 4 (25) SD 6 (38) DCR a 10 (63) PD 3 (19) Not evaluable/no assessment 3 (19) Median TTR (range), mo 3.7 (1.8–7.4) Median DOR (range), mo 7.8 (1.9+–7.8) PFS events, n (%) 6 (38) Median PFS (95% CI), mo 9.6 (1.7–NE) 9-mo PFS rate (95% CI), % 56 (24–79) OS events, n (%) 7 (44) Median OS (95% CI), mo 12.3 (7.6–NE) 9-mo OS rate (95% CI), % 67 (38–85) a CR + PR + SD. Conclusions Sac-TMT showed preliminary antitumor activity and manageable safety in pts with advanced KRAS -mutant NSCLC."

Clinical • IO biomarker • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • KRAS

SKB315, a novel claudin 18.2 (CLDN18.2) antibody-drug conjugate (ADC), in patients (pts) with advanced solid tumors including gastric/ gastroesophageal junction cancer (GC/GEJC): A phase I study (ESMO 2025) - P1 | "SKB315 is a novel ADC designed to target CLDN18.2, developed with a proprietary Kthiol (pyrimidine-thiol) linker to conjugate a belotecan-derivative topoisomerase I inhibitor as the payload. Conclusions SKB315 demonstrated a manageable safety profile in pts with advanced solid tumor and showed a promising antitumor activity in pts with CLDN18.2-expressing advanced GC/GEJC. These findings warrant further evaluation of SKB315 in CLDN18.2-expressing solid tumors."

Clinical • Metastases • P1 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18

Investigational DNA topoisomerase I inhibitors for colorectal cancer: preclinical and early phase developments. (PubMed, Expert Opin Investig Drugs) - "Despite the success of CPT derivatives like irinotecan, topotecan and belotecan (approved drugs), drawbacks such as lactone instability have led to the development of modified compounds. Dual inhibitors, combination therapies, integration with immunotherapy and personalized medicine further enhances treatment efficacy. Ongoing preclinical studies offer hope for improved CRC management."

Journal • Preclinical • Review • Colorectal Cancer • Oncology • Solid Tumor

Results of a phase 1/2 study of sacituzumab tirumotecan in patients with unresectable locally advanced or metastatic solid tumors refractory to standard therapies. (PubMed, J Hematol Oncol) - P1/2 | "Sac-TMT demonstrated manageable safety profile in patients with unresectable locally advanced/metastatic solid tumors and promising antitumor activity in metastatic TNBC and HR+/HER2 - breast cancer. Sac-TMT is being investigated in phase 3 studies."

Journal • P1/2 data • Breast Cancer • Dental Disorders • Dermatology • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Immunology • Oncology • Solid Tumor • Stomatitis • Triple Negative Breast Cancer • Urticaria • HER-2

Sacituzumab tirumotecan (sac-TMT) in patients (pts) with previously treated locally advanced or metastatic (LA/M) non-small cell lung cancer (NSCLC) harboring uncommon EGFR mutations: Preliminary results from a phase 2 study. (ASCO 2025) - P2 | "Sac-TMT (MK-2870/SKB264) is a TROP2 ADC developed with a hydrolytically cleavable linker to conjugate a belotecan-derivative topoisomerase I inhibitor. Sac-TMT monotherapy demonstrated promising clinical activity with a manageable safety profile in previously treated advanced NSCLC pts with uncommon EGFR mutations. These findings warrant further investigation of sac-TMT as a potential therapy for this population."

Clinical • Metastases • P2 data • Anemia • Dental Disorders • Interstitial Lung Disease • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Stomatitis • EGFR

KEYMAKER-U01E: A phase 2 umbrella study with rolling arms of investigational agents with or without chemotherapy plus pembrolizumab for resectable stage II–IIIB (N2) non–small-cell lung cancer (NSCLC). (ASCO 2025) - P2 | "Sacituzumab tirumotecan (sac-TMT/MK-2870/SKB264) is an antibody-drug conjugate composed of an anti-trophoblast cell surface antigen 2 antibody, a hydrolytically cleavable linker, and a belotecan-derivative topoisomerase I inhibitor payload (average drug-to-antibody ratio, 7.4)...In Arm 1 (reference arm), pts will receive neoadjuvant therapy of 4 cycles of pembro 200 mg intravenously (IV) + CT IV Q3W (cisplatin 75 mg/m2 or carboplatin area under the curve 5 or 6 mg/mL/min on day 1 with gemcitabine 1000 mg/m2 on days 1 and 8 for squamous histology, with pemetrexed 500 mg/m2 on day 1 for nonsquamous, or with paclitaxel 175 or 200 mg/m2 on day 1 for any histology)...AEs will be graded per NCI CTCAE v5.0. Enrollment is scheduled to begin in March 2025 at 34 sites globally."

P2 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR