Eli Lilly and Co. announced the expansion of an existing immuno-oncology collaboration with to add a new study of Lilly’s Lartruvo (olaratumab) with Keytruda (pembrolizumab) in patients with previously treated advanced or metastatic soft tissue sarcoma.
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.
Lilly is the sponsor of the phase 1 study and enrollment is expected to begin mid-2017. 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, including a phase III study that is currently enrolling patients;
A phase I study examining the combination of ramucirumab with pembrolizumab in NSCLC, gastric cancer and bladder cancer;
A phase I study examining the combination of necitumumab with pembrolizumab in NSCLC; and
A phase I study examining the combination of abemaciclib, a CDK 4 and 6 inhibitor, with pembrolizumab. Based on the phase I trial results, the collaboration has the potential to progress top Phase II trials in patients who have been diagnosed with either metastatic breast cancer or NSCLC.