INDIANAPOLIS, Indiana, USA - Eli Lilly and Company (NYSE: LLY) today announced the expansion of an existing immuno-oncology collaboration with Merck, known as MSD outside the U.S. and Canada, through a subsidiary, 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).
Notably, the U.S. Food and Drug Administration (FDA) recently granted accelerated approval for LARTRUVO (olaratumab injection, 10 mg/mL), in combination with doxorubicin, for the treatment of adults with STS with a histologic subtype for which an anthracycline-containing regimen is appropriate and which is not amenable to curative treatment with radiotherapy or surgery. LARTRUVO (olaratumab injection, 10 mg/mL), in combination with doxorubicin, also recently received conditional marketing authorization from the European Medicines Agency for the treatment of adults with advanced STS not amenable to curative treatment with surgery or radiotherapy and who have not been previously treated with doxorubicin.
"We look forward to further expanding our collaboration with Merck to include this combination study focused on advanced soft tissue sarcoma, a rare and difficult-to-treat disease with limited treatment options," said Sue Mahony, Ph.D., senior vice president and president, Lilly Oncology. "This collaborative study builds on the exciting data we have seen with olaratumab and supports our focus on investigating the potential of rational combinations to enhance efficacy and change the standards of care for people with cancer."
"Historic and present day scientific advances continue to reinforce the role of combination therapies in extending the lives of people with cancer," said Eric Rubin, M.D., vice president and therapeutic area head, oncology early-stage development, Merck Research Laboratories. "Our collaboration with Lilly exemplifies our commitment to fully exploring combination regimens with KEYTRUDA to help arm physicians with the treatment tools they need to help their patients."
Lilly is the sponsor of the Phase 1 study and enrollment is expected to begin mid-2017. Financial details of the collaboration were not disclosed.
In addition to the study announced today, other ongoing trials between Lilly and Merck, 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.
Olaratumab (marketed under the brand name LARTRUVO™) is a platelet-derived growth factor receptor alpha (PDGFR-α) blocking antibody that specifically binds PDGFR-α and prevents receptor activation. LARTRUVO exhibits in vitro and in vivo anti-tumor activity against selected sarcoma cell lines and disrupted the PDGFR-α signaling pathway in in vivo tumor implant models.
Pembrolizumab (marketed under the brand name KEYTRUDA®) is a humanized monoclonal antibody that works by increasing the ability of the body's immune system to help detect and fight tumor cells. Pembrolizumab blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes, which may affect both tumor cells and healthy cells.
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