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

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

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 | Recruiting ➔ Active, not recruiting | Trial completion date: Oct 2025 ➔ Oct 2027

Combination therapy • Enrollment closed • Metastases • Trial completion date • Gastrointestinal Cancer • Hepatocellular Cancer • Hepatology • Liver Cancer • Oncology • Solid Tumor

Anaptys Announces Second Quarter 2024 Financial Results and Provides Business Update (GlobeNewswire) - "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 to docetaxel alone in patients with advanced NSCLC who have progressed on prior anti-PD-(L)1 therapy and chemotherapy; GSK anticipates top-line data in H2 2024 from the FIRST Phase 3 trial for platinum-based therapy with dostarlimab and niraparib versus platinum-based therapy as first-line treatment of Stage III or IV nonmucinous epithelial ovarian cancer."

P3 data: top line • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer

A Study of Cobolimab Plus Dostarlimab in Pediatric and Young Adult Participants With Cancer (clinicaltrials.gov) - P1/2 | N=131 | Not yet recruiting | Sponsor: GlaxoSmithKline

Combination therapy • New P1/2 trial • Melanoma • Oncology • Pediatrics • 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=56 | Recruiting | Sponsor: Diwakar Davar | Trial completion date: Oct 2027 ➔ Apr 2029 | Trial primary completion date: Jan 2025 ➔ Sep 2025

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

Study of Niraparib, TSR-022, Bevacizumab, and Platinum-Based Doublet Chemotherapy in Combination With TSR-042 (clinicaltrials.gov) - P1 | N=58 | Active, not recruiting | Sponsor: Tesaro, Inc. | Trial completion date: Apr 2024 ➔ Aug 2024

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

A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER) (clinicaltrials.gov) - P1 | N=475 | Recruiting | Sponsor: Tesaro, Inc. | Trial completion date: Jul 2025 ➔ Apr 2027 | Trial primary completion date: Dec 2024 ➔ Apr 2025

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

Anaptys Announces First Quarter 2024 Financial Results and Provides Business Update (GlobeNewswire) - "Updates on GSK Immuno-Oncology Financial Collaboration:...GSK anticipates top-line data in 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 to docetaxel alone in patients with advanced NSCLC who have progressed on prior anti-PD-(L)1 therapy and chemotherapy."

P3 data: top line • Non Small Cell Lung Cancer

A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER) (clinicaltrials.gov) - P1 | N=475 | Recruiting | Sponsor: GlaxoSmithKline

Metastases • New P1 trial • Hepatocellular Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Anaptys Announces Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update (GlobeNewswire) - "Updates on GSK Immuno-Oncology Financial Collaboration: (i) GSK anticipates top-line data in H2 2024 from COSTAR Lung Phase 3 trial comparing cobolimab, a TIM-3 antagonist, plus dostarlimab, a PD-1 antagonist, plus docetaxel to dostarlimab plus docetaxel to docetaxel alone in patients with advanced NSCLC who have progressed on prior anti-PD-(L)1 therapy and chemotherapy; (ii) GSK anticipates top-line data in H1 2024 from the FIRST Phase 3 trial for platinum-based therapy with dostarlimab and niraparib versus platinum-based therapy as first-line treatment of Stage III or IV nonmucinous epithelial ovarian cancer."

P3 data: top line • Non Small Cell Lung Cancer • Ovarian Cancer

TSR-022 (Anti-TIM-3 Antibody) and TSR-042 (Anti-PD-1 Antibody) in Patients With Liver Cancer (clinicaltrials.gov) - P2 | N=42 | Recruiting | Sponsor: University of Hawaii | Trial completion date: Oct 2023 ➔ Oct 2025 | Trial primary completion date: Oct 2022 ➔ Oct 2024

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

Dostarlimab and Cobolimab in Advanced Cervical Cancer (clinicaltrials.gov) - P2 | N=66 | Recruiting | Sponsor: Meghan Shea | Not yet recruiting ➔ Recruiting | Initiation date: Jul 2024 ➔ Mar 2024

Combination therapy • Enrollment open • Metastases • Trial initiation date • Cervical Cancer • Oncology • Solid Tumor

Dostarlimab and Cobolimab in Advanced Cervical Cancer (clinicaltrials.gov) - P2 | N=66 | Not yet recruiting | Sponsor: Meghan Shea

Combination therapy • Metastases • New P2 trial • Cervical Cancer • Oncology • Solid Tumor

Cobolimab/Dostarlimab Combination Shows Initial Efficacy and Safety Signals in Advanced NSCLC (OncLive) - "Based on the findings shown here, and previously reported receptor occupancy, safety [no dose limiting toxicities], pharmacokinetics, pharmacodynamics, and efficacy, 30 mg [of] cobolimab in combination with dostarlimab was confirmed to be the recommended phase 2 dose,' Diwakar Davar, MD, MSc, stated in a presentation of the data....Davar concluded the presentation by highlighting the ongoing phase 2/3 COSTAR trial (NCT04655976). The study is comparing the combination of cobolimab, dostarlimab, and docetaxel with dostarlimab plus docetaxel, and docetaxel alone in patients with relapsed/refractory advanced NSCLC who received prior PD-(L)1 thereapy."

Media quote

Cobolimab/Dostarlimab Combination Shows Initial Efficacy and Safety Signals in Advanced NSCLC (OncLive) - P1 | N=475 | AMBER (NCT02817633) | Sponsor: Tesaro, Inc. | "The anti–TIM-3 monoclonal antibody, cobolimab (TSR-022/GSK4069889), utilized in combination with the anti–PD-1 antibody dostarlimab-gxly (Jemperli) demonstrated promising signs of clinical activity and an acceptable safety profile across all dose levels in heavily pretreated patients with advanced/metastatic non–small cell lung cancer...Among the 84 patients in the total study population, cobolimab plus dostarlimab elicited an overall response rate (ORR) of 8.3% (95% CI, 3.4%-16.4%) and a disease control rate (DCR) was 21.4% (95% CI, 13.2%-31.7%)....The median PFS for the 100 mg (n = 14), 300 mg (n = 21), and 900 mg (n = 29) dosing levels were 1.9 months (95% CI, 0.8-3.4), 2.1 months (95% CI, 1.9-3.8), and 2.1 months (95% CI, 1.9-2.2), respectively. The median OS for each respective dose levels was 11.6 months (95% CI, 2.8-not evaluable), 6.2 months (95% CI, 4.1-12.9), and 9.0 months (95% CI, 3.7-14.7)."

P1 data • Non Small Cell Lung Cancer

AMBER: Anti-TIM3 Antibody Reverses T-cell Exhaustion in NSCLC (YouTube) - "Diwakar Davar, MD...discusses findings from the AMBER trial (NCT02817633) of cobolimab, an anti-TIM-3 monoclonal antibody, alone or with PD-1 inhibitors in patients with non-small cell lung cancer (NSCLC). Cobolimab plus dostarlimab combination therapy in patients with NSCLC previously treated with anti-PD(L)-1 therapy returned some evidence of efficacy and progression-free survival with responders having higher expression of TIM3...This interview took place at the Society for Immunotherapy of Cancer's (SITC) 38th Annual Meeting in San Diego, CA."

Interview • Video

Study of Niraparib, TSR-022, Bevacizumab, and Platinum-Based Doublet Chemotherapy in Combination With TSR-042 (clinicaltrials.gov) - P1 | N=58 | Active, not recruiting | Sponsor: Tesaro, Inc. | Phase classification: P1b ➔ P1

Phase classification • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Anti-TIM3 chimeric antigen receptor-natural killer cells from engineered induced pluripotent stem cells effectively target acute myeloid leukemia cells. (PubMed, Cancer Cell Int) - "iPSCs engineered with CARs, including the established single-cell clone CAR-TIM3 iPSCs herein, are potential alternative cell source for generating off-the-shelf CAR-NK cells as well as other CAR-immune cells. The feasibility of differentiation of functional CAR-TIM3 NK cells under serum- and feeder-free conditions support that Good Manufacturing Practice (GMP)-compliant protocols can be further established for future clinical applications."

Journal • Acute Myelogenous Leukemia • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Leukemia • Oncology

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) - P2/3 | N=758 | Active, not recruiting | Sponsor: GlaxoSmithKline | Recruiting ➔ Active, not recruiting

Cost of therapy • Enrollment closed • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

AMBER, Part 2B: a phase 1 study of cobolimab plus dostarlimab in patients with advanced/metastatic non-small cell lung cancer (NSCLC) previously treated with anti-PD(L)-1 therapy (SITC 2023) - P1, P2/3 | "Conclusions Cobolimab plus dostarlimab showed early evidence of efficacy and acceptable safety in patients with advanced/metastatic NSCLC. Cobolimab plus dostarlimab and docetaxel versus standard of care is being evaluated in COSTAR, an ongoing Phase 2/3 study (NCT04655976) for patients with advanced NSCLC."

Clinical • IO biomarker • Metastases • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • CXCL8 • IL6

Study of the Safety and Effectiveness of GSK6097608 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=244 | Recruiting | Sponsor: GlaxoSmithKline | N=184 ➔ 244 | Trial completion date: Jul 2024 ➔ Sep 2025 | Trial primary completion date: Jul 2024 ➔ Sep 2025

Combination therapy • Enrollment change • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Endometrial Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Dose Escalation and Expansion Study of GSK3359609 in Participants With Selected Advanced Solid Tumors (INDUCE-1) (clinicaltrials.gov) - P1 | N=829 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed

Combination therapy • Metastases • Trial completion • Esophageal Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • ICOS • MSI

AnaptysBio Announces Second Quarter 2023 Financial Results and Provides Business Update (GlobeNewswire) - "GSK anticipates top-line data in H1 2024 from the FIRST Phase 3 trial for platinum-based therapy with dostarlimab and niraparib versus platinum-based therapy as first-line treatment of Stage III or IV nonmucinous epithelial ovarian cancer; GSK anticipates top-line data in H2 2024 from COSTAR Lung Phase 3 trial comparing cobolimab plus dostarlimab plus docetaxel to dostarlimab plus docetaxel to docetaxel alone in patients with advanced NSCLC who have progressed on prior anti-PD-(L)1 therapy and chemotherapy."

P3 data: top line • Fallopian Tube Cancer • Gynecologic Cancers • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

Study of Niraparib, TSR-022, Bevacizumab, and Platinum-Based Doublet Chemotherapy in Combination With TSR-042 (clinicaltrials.gov) - P1b | N=58 | Active, not recruiting | Sponsor: Tesaro, Inc. | Trial completion date: Apr 2023 ➔ Apr 2024

Combination therapy • Metastases • Trial completion date • Head and Neck Cancer • 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=184 | Recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Apr 2025 ➔ Jul 2024 | Trial primary completion date: Apr 2025 ➔ Jul 2024

Combination therapy • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Oncology • Solid Tumor