FDA grants Eli Lilly a priority review for soft tissue sarcoma drug

Lilly CEO Leichleiter

After a poor year for approvals in 2015--and promises of a stronger 2016--Eli Lilly ($LLY) has been given a much-needed speedy review from the FDA for its experimental sarcoma drug olaratumab.

Specifically, the U.S. regulator has granted a “Priority Review”--which speeds up the time it takes to decide whether to approve a new med--for Lilly’s BLA for olaratumab, with a chemotherapy agent, for patients with advanced soft tissue sarcoma (STS) that has not been helped by radiotherapy or surgery.

The drug works as a PDGFRα antagonist, with this protein often found on the surface of cells where it is thought to play a role in regulating cell multiplication.

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In cancers such as soft tissue sarcoma, these proteins are present in high levels or overactive, causing cells to become cancerous. When olaratumab (LY3012207) attaches to PDGFRα on sarcoma cells, it is expected to block its activity, thereby slowing down the growth of the cancer.

Lilly has already got additional designations for olaratumab from the FDA, including “Breakthrough Therapy,” “Fast Track” and “Orphan Drug” for this indication. It now has a full house, with the priority review shortening the drug’s assessment by the FDA from 10 months to 6 months--meaning a decision could be reached on olaratumab by November.

"We are encouraged that the FDA has granted priority review for olaratumab as a potential treatment for advanced soft tissue sarcoma," said Dr. Richard Gaynor, senior vice president of product development and medical affairs for Lilly Oncology, in a statement. "We are hopeful that, if approved, olaratumab will provide a meaningful addition to the limited treatment options for this rare and difficult-to-treat disease." Current drugs include chemotherapy agents, with surgery and radiotherapy also used.

There is however a new treatment, approved by the FDA last fall, for Janssen’s ($JNJ) Yondelis (trabectedin), a chemotherapy-type drug for advanced, STS liposarcoma and leiomyosarcoma. This treatment is approved for patients who previously received chemotherapy that contained anthracycline. LPS and LMS account for 35% of all soft tissue sarcoma cases, of which there are 50 subtypes. LMS is aggressive and generally occurs in smooth muscles such as those in the uterus, abdominal cavity or blood vessels.

The BLA submission for olaratumab was based upon the results from a pivotal Phase II trial, JGDG, an open-label, randomized study that compared olaratumab in combination with doxorubicin to doxorubicin alone in patients with advanced STS.

In the midstage, randomized trial, 133 unresectable/metastatic soft-tissue sarcoma patients (median age 58 years) received up to 8 cycles of doxorubicin 75 mg/m2 with or without olaratumab 15 mg/kg. In the combination arm, olaratumab monotherapy continued after doxorubicin until disease progression. In the doxorubicin-alone arm, patients could cross over to olaratumab at progression.

In data released at ASCO last year, the primary endpoint of progression-free survival was met, with median PFS hitting 6.6 months in the combination arm and 4.1 months in the doxorubicin-alone arm.

Olaratumab added to doxorubicin also achieved a statistically significant improvement of 10.3 months in median overall survival over doxorubicin alone.

Similarly, objective response rates were higher in the combination arm (18.8%) as compared to the doxorubicin-alone arm (12.3%).

There were however higher rates of neutropenia in the combo arm (51.5% vs. 33.8%), as well as anemia (12.5% vs. 7.7%) and fatigue (9.4% vs. 3.1%).

Lilly is also now recruiting patients for a new open label Phase Ib and a randomized, double-blinded Phase II study with its own multiple cancer chemotherapy agent Gemzar (gemcitabine) and docetaxel--in combo with or without olaratumab--for advanced soft tissue sarcoma. The studies will look at safety and overall survival, with the trial set to end in 2020.

Lilly submitted olaratumab to the EMA in the last quarter, with this application also being reviewed under an accelerated program.

Soft tissue sarcoma is a type of cancer that affects the soft, supportive tissues of the body. It can occur in muscles, blood vessels, fat tissue or in other tissues that support, surround and protect organs.

It’s a rare disease that according to the National Cancer Institute saw around 12,000 cases in the U.S., with around 4,700 deaths from the cancer.

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