cobolimab (TSR-022) / AnaptysBio, GSK - LARVOL DELTA

Results from COSTAR lung: cobolimab + dostarlimab + docetaxel and dostarlimab + docetaxel versus docetaxel alone in patients with previously treated advanced/metastatic (A/M) non-small cell lung cancer (NSCLC) (ESMO-IO 2025) - P3 | "Safety and immune-related toxicity were comparable across the applicable arms. Table: 241MO AE, adverse event; mo, months; N/A, not applicable; TE, treatment emergent Conclusions In COSTAR Lung, cobolimab + dostarlimab + docetaxel and dostarlimab + docetaxel did not meet the planned primary endpoint of survival (OS) compared with docetaxel alone.Clinical trial identification NCT04655976.Legal entity responsible for the study GSK."

Clinical • IO biomarker • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HAVCR2

A Study of Cobolimab Plus Dostarlimab in Pediatric and Young Adult Participants With Cancer (clinicaltrials.gov) - P1/2 | N=83 | Active, not recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Jan 2032 ➔ Oct 2026 | Trial primary completion date: Jan 2032 ➔ Oct 2026

Trial completion date • Trial primary completion date • Brain Cancer • Diffuse Intrinsic Pontine Glioma • Ependymoma • Glioblastoma • Glioma • Hematological Malignancies • Hepatoblastoma • Hepatocellular Cancer • Liver Cancer • Lymphoma • Melanoma • Oncology • Osteosarcoma • Pediatrics • Rhabdomyosarcoma • Sarcoma • Solid Tumor

Lysine-specific demethylase 1 (LSD1) inhibition modulates tumor progression and immunotherapeutic priming effects in triple-negative breast cancers (SITC 2025) - "Importantly, cell-derived xenograft humanized mice models treated with immunotherapy combinations (nivolumab, ipilimumab, cobolimab)-coupled LSD1 inhibitor significantly reduced tumor size compared to control group.Conclusions Our study underscores the clinical potential of LSD1-targeted epigenetic drugs to sensitize TNBC tumors to immunotherapies. Additionally, our findings suggest LSD1 cooperates with the AP-1 transcriptional complex to drive oncogenic gene expression programs that promote tumor progression and immune evasion in TNBC, defining a novel LSD1-AP-1 transcriptional axis in TNBC. These findings support combination strategies incorporating LSD1 inhibitors with immune checkpoint blockade for improved therapeutic outcomes in TNBC.Ethics Approval Ethics approval was obtained from The Centralized Institutional Review Board of Singhealth, Singapore.Consent Consent was waived for this study from The Centralized Institutional Review Board of Singhealth, Singapore."

IO biomarker • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • KDM1A • PD-L1

Study of Niraparib, TSR-022, Bevacizumab, and Platinum-Based Doublet Chemotherapy in Combination With TSR-042 (clinicaltrials.gov) - P1 | N=60 | Completed | Sponsor: Tesaro, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Aug 2024 ➔ Dec 2024

Trial completion • Trial completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Study of the Safety and Effectiveness of GSK6097608 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=107 | Active, not recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Monotherapy • Trial completion date • Trial primary completion date • Colorectal Cancer • Endometrial Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Dostarlimab and Cobolimab in Advanced Cervical Cancer (clinicaltrials.gov) - P2 | N=66 | Recruiting | Sponsor: Meghan Shea | Trial primary completion date: Feb 2026 ➔ Dec 2026

Trial primary completion date • Cervical Cancer • Oncology • Solid Tumor

A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER) (clinicaltrials.gov) - P1 | N=463 | Active, not recruiting | Sponsor: Tesaro, Inc. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Apr 2025 ➔ Mar 2027

Enrollment closed • Trial primary completion date • Colorectal Cancer • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Neo-MEL-T: Neoadjuvant PD-1 Inhibitor Dostarlimab (TSR-042) vs. Combination of Tim-3 Inhibitor Cobolimab (TSR-022) and PD-1 Inhibitor Dostarlimab (TSR-042) in Melanoma (clinicaltrials.gov) - P2 | N=48 | Active, not recruiting | Sponsor: Diwakar Davar | Recruiting ➔ Active, not recruiting | Trial completion date: Apr 2029 ➔ Dec 2029

Enrollment closed • Trial completion date • Melanoma • Oncology • Solid Tumor

COSTAR Lung: Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants With Advanced Non-small Cell Lung Cancer Who Have Progressed on Prior Anti-PD-(L)1 Therapy and Chemotherapy (clinicaltrials.gov) - P3 | N=758 | Active, not recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Oct 2025 ➔ Mar 2027

Trial completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of Cobolimab Plus Dostarlimab in Pediatric and Young Adult Participants With Cancer (clinicaltrials.gov) - P1/2 | N=95 | Active, not recruiting | Sponsor: GlaxoSmithKline | Trial primary completion date: Oct 2029 ➔ Jan 2032 | Recruiting ➔ Active, not recruiting

Enrollment closed • Trial primary completion date • Brain Cancer • Diffuse Intrinsic Pontine Glioma • Ependymoma • Glioblastoma • Glioma • Hematological Malignancies • Hepatoblastoma • Hepatocellular Cancer • Liver Cancer • Lymphoma • Melanoma • Oncology • Osteosarcoma • Pediatrics • Rhabdomyosarcoma • Sarcoma • Solid Tumor

GSK’s anti-TIM-3 antibody fails in Phase III NSCLC trial (pharmaphorum) - P3 | N=758 | COSTAR Lung (NCT04655976) | Sponsor: GlaxoSmithKline | "GSK has become the latest drugmaker to run into difficulties in developing a drug targeting the immune checkpoint receptor TIM-3, after its cobolimab candidate flunked a phase 3 trial in lung cancer. In its second-quarter update this morning, GSK revealed that the COSTAR study of cobolimab in combination with its PD-1 inhibitor Jemperli (dostarlimab) and docetaxel was unable to show any improvement in overall survival (OS) in advanced non-small cell lung cancer (NSCLC) patients previously treated with PD-1/PD-L1 inhibitor-based cancer immunotherapies."

P3 data • Non Small Cell Lung Cancer

Combined Targeting of PD-1 and TIM-3 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer: AMBER Part 2B. (PubMed, Clin Cancer Res) - P1 | "Cobolimab plus dostarlimab showed preliminary efficacy and tolerability in a subset of patients with locally advanced/metastatic NSCLC. See related article by Davar et al., p. XX."

IO biomarker • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HAVCR2 • PD-1

Combined Targeting of PD-1 and TIM-3 in Patients with Locally Advanced or Metastatic Melanoma: AMBER Cohorts 1c, 1e, and 2A. (PubMed, Clin Cancer Res) - P1 | "In this exploratory setting, cobolimab plus dostarlimab was well tolerated, with reported preliminary efficacy similar to other anti-T-cell immunoglobulin and mucin-domain containing protein-3 treatments in patients with locally advanced/metastatic melanoma. See related article by Davar et al., p. XX."

Journal • Melanoma • Oncology • Solid Tumor • HAVCR2 • PD-1

Dostarlimab Plus Cobolimab Improves MPR Rate vs Dostarlimab in High-Risk Resectable Melanoma (OncLive) - P2 | N=62 | NEO-MEL-T (NCT04139902) | "The addition of cobolimab to dostarlimab-gxly (Jemperli) was tolerable and led to efficacy improvements compared with dostarlimab monotherapy for the neoadjuvant treatment of patients with high-risk resectable melanoma, according to data from the phase 2 NEO-MEL-T trial (NCT04139902) presented during the 2025 ASCO Annual Meeting. Findings from the primary analysis of NEO-MEL-T demonstrated that patients who received the combination (n = 27) achieved a major pathological response (MPR) rate of 55.6% and those who received dostarlimab alone (n = 30) experienced an MPR rate of 33.3%. The pathological complete response rates were 37% and 33.3%, respectively. Additionally, 18.5% and 3.7% of patients in the combination arm experienced a pathological major response or a pathological partial response, respectively."

P2 data • Melanoma

Cobolimab and dostarlimab in the first-line treatment of unresectable hepatoma: A multi-center, single arm, phase 2 trial. (ASCO 2025) - P2 | "Cobolimab plus dostarlimab yielded promising response rates and survival outcomes with acceptable safety as first-line treatment in patients with CP A, unresectable HCC. This represents a potential therapy regimen for this population. Clinical trial information: NCT03680508."

Clinical • P2 data • Endocrine Disorders • Hepatocellular Cancer • Liver Cancer • Solid Tumor

Randomized phase II study of neoadjuvant (neoadj) anti-PD-1 dostarlimab (D) vs. D + anti-TIM-3 cobolimab (C) in high-risk resectable melanoma (mel) (NEO-MEL-T): Primary analysis. (ASCO 2025) - P2 | "Neoadj D+C was safe and efficacious. The 1-year EFS of 92% in Arm B was significantly improved relative to adjuvant anti-PD-1, and this combination warrants further investigation. Clinical trial information: NCT04139902."

Clinical • Late-breaking abstract • P2 data • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HAVCR2

Study of the Safety and Effectiveness of GSK6097608 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=107 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting | N=244 ➔ 107 | Trial completion date: Sep 2025 ➔ Dec 2025 | Trial primary completion date: Sep 2025 ➔ Dec 2025

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Colorectal Cancer • Endometrial Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Phase 2 Study of Dostarlimab in Combination with Cobolimab in Advanced Cervical Cancer (SGO 2025) - No abstract available

Combination therapy • Metastases • P2 data • Cervical Cancer • Oncology • Solid Tumor

Anaptys Announces Fourth Quarter and Full Year 2024 Financial Results and Provides Business Update (GlobeNewswire) - "GSK Immuno-Oncology Financial Collaboration: (i) GSK announced strong commercial performance for Jemperli ($190 million in Q4 2024 sales) with >100% year-over-year growth; (ii) GSK anticipates top-line data in H1 2025 from COSTAR Lung Phase 3 trial comparing cobolimab, a TIM-3 antagonist, plus dostarlimab, a PD-1 antagonist, plus docetaxel to dostarlimab plus docetaxel and to docetaxel alone in patients with advanced NSCLC who have progressed on prior anti-PD-(L)1 therapy and platinum-based chemotherapy; (iii) GSK anticipates top-line data in 2026 from AZUR-1 pivotal Phase 2 trial of dostarlimab monotherapy in patients with untreated stage II/III dMMR/MSI-H locally advanced rectal cancer."

P2 data • P3 data: top line • Sales • Endometrial Cancer • Non Small Cell Lung Cancer • Rectal Cancer

A Study of Cobolimab Plus Dostarlimab in Pediatric and Young Adult Participants With Cancer (clinicaltrials.gov) - P1/2 | N=95 | Recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Nov 2030 ➔ Jan 2032 | Trial primary completion date: Aug 2028 ➔ Oct 2029

Trial completion date • Trial primary completion date • Melanoma • Oncology • Pediatrics • Solid Tumor

Cobolimab: Acceptance of regulatory submissions in US/EU (based on COSTAR trial) for 2L NSCLC in H2 2025 (GSK) - Q4 & FY2024 Results: Regulatory decisions in US/EU (based on COSTAR trial) for 2L NSCLC in 2026

EMA approval • EMA filing • FDA approval • FDA filing • Lung Cancer • Non Small Cell Lung Cancer • Oncology

AMBER part 2F: Cobolimab in combination with dostarlimab in treatment-naïve patients with locally advanced/metastatic and/or unresectable hepatocellular carcinoma (HCC). (ASCO-GI 2025) - P1 | "Time-to-event analyses will be performed via Kaplan–Meier methods. After ~25 pts have been followed-up for ≥3 scans, an interim analysis may be performed."

Clinical • Combination therapy • IO biomarker • Metastases • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • AFP

A Study of Cobolimab Plus Dostarlimab in Pediatric and Young Adult Participants With Cancer (clinicaltrials.gov) - P1/2 | N=95 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting | Initiation date: Sep 2024 ➔ Dec 2024

Enrollment open • Trial initiation date • Melanoma • Oncology • Pediatrics • Solid Tumor

TSR-022 (anti-TIM-3 Antibody) and TSR-042 (anti-PD-1 Antibody) in Patients with Liver Cancer (clinicaltrials.gov) - P2 | N=42 | Active, not recruiting | Sponsor: University of Hawaii | Trial primary completion date: Oct 2024 ➔ Oct 2025

Combination therapy • Metastases • Trial primary completion date • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor

COSTAR Lung: Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants With Advanced Non-Small Cell Lung Cancer Who Have Progressed on Prior Anti- Programmed Death-ligand 1 (PD-[L]1) Therapy and Chemotherapy (clinicaltrials.gov) - P3 | N=758 | Active, not recruiting | Sponsor: GlaxoSmithKline | Phase classification: P2/3 ➔ P3 | Trial primary completion date: Oct 2024 ➔ Apr 2025

Cost of therapy • Metastases • Phase classification • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor