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Agreements

Date: 2017-01-13

Type of information: Clinical research agreement

Compound: Lartruvo™ (olaratumab) and Keytruda® (pembrolizumab)

Company: Eli Lilly (USA - IN) Merck&Co (USA - NJ)

Therapeutic area: Cancer - Oncology

Type agreement:

clinical research

Action mechanism:

monoclonal antibody/immune checkpoint inhibitor. Olaratumab is a fully human IgG1 monoclonal antibody designed to bind to the platelet-derived growth factor receptor alpha (PDGFR alpha) and block PDGFR alpha activation. PDGFR alpha is expressed in a variety of tumor types, plays an important role in cancer growth and metastasis, and modulates stromal- and angiogenesis-driven mechanisms of cancer growth. PDGFR alpha and its ligands are coexpressed in many tumor types, and PDGFR alpha overexpression is associated with increased metastasis.

Keytruda® (pembrolizumab - MK-3475) is an investigational, highly selective monoclonal anti-PD-1 antibody designed to restore the natural ability of the immune system to recognize and target cancer cells by selectively achieving dual ligand blockade (PD-L1 and PD-L2) of the PD-1 protein. By blocking PD-1, MK-3475 enables activation of the immune system’s T-cells that target cancer by essentially releasing a brake on the immune system. MK-3475 is currently being studied in three clinical trials for advanced melanoma including a Phase III trial of MK-3475 versus ipilimumab in ipilimumab-naïve advanced melanoma patients (PN 006). Enrollment is complete in the advanced melanoma cohorts in the company’s Phase IB trial (PN 001) and the Phase II trial (PN 002) comparing two doses of MK-3475 versus chemotherapy in patients with advanced melanoma who have progressed after prior therapy. Keytruda® is the first approved drug that blocks the PD-1 cellular pathway.

Disease: soft tissue sarcoma

Details:

* On January 11, 2017, Eli Lilly announced the expansion of an existing immuno-oncology collaboration with Merck&co, to add a new study of Lilly's Lartruvo™ (olaratumab) with Keytruda® (pembrolizumab) in patients with previously treated advanced or metastatic soft tissue sarcoma (STS). Lilly is the sponsor of the Phase 1 study and enrollment is expected to begin mid-2017. 

In addition to this study announced , other ongoing trials between Lilly and Merck&Co, through a subsidiary, include:

Studies of pemetrexed (plus carboplatin) and pembrolizumab in first-line nonsquamous non-small cell lung cancer (NSCLC), including a Phase 3 study that is currently enrolling patients;
A Phase 1 study examining the combination of ramucirumab with pembrolizumab in NSCLC, gastric cancer and bladder cancer;
A Phase 1 study examining the combination of necitumumab with pembrolizumab in NSCLC; and
A Phase 1 study examining the combination of abemaciclib, a CDK 4 and 6 inhibitor, with pembrolizumab. Based on the Phase 1 trial results, the collaboration has the potential to progress to Phase 2 trials in patients who have been diagnosed with either metastatic breast cancer or NSCLC.

Financial terms:

Financial details of the collaboration were not disclosed.

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Is general: Yes