COMUNICADO: European Commission Grants Lilly's LARTRUVO(TM) (olaratumab), in Combination with Doxorubicin, Approval for the Treatmen

 
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COMUNICADO: European Commission Grants Lilly's LARTRUVO(TM) (olaratumab), in Combination with Doxorubicin, Approval for the Treatmen

Publicado 11/11/2016 9:21:34CET

-- LARTRUVO, in combination with doxorubicin, is the first front-line therapy approved in four decades for advanced soft tissue sarcoma in Europe

-- JGDG study showed LARTRUVO, in combination with doxorubicin, offered a median 11.8-month increase in overall survival compared to doxorubicin alone

-- LARTRUVO, in combination with doxorubicin, is the first approved monoclonal antibody to treat advanced soft tissue sarcoma

INDIANAPOLIS, Nov. 11, 2016 /PRNewswire/ -- Eli Lilly and Company announced today that the European Commission (EC) granted conditional marketing authorisation for LARTRUVO(TM) (olaratumab injection, 10 mg/mL), in combination with doxorubicin, to treat adults with advanced soft tissue sarcoma (STS) not amenable to curative treatment with radiotherapy or surgery and who have not been previously treated with doxorubicin. The Committee for Medicinal Products for Human Use (CHMP) reviewed LARTRUVO under the European Medicines Agency's accelerated assessment program.

LARTRUVO, in combination with doxorubicin, is also the first approved monoclonal antibody to treat advanced soft tissue sarcoma. This approval is based on data from the Phase 2 portion of the pivotal JGDG trial and followed a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) announced on 16 September 2016.

"LARTRUVO, in combination with doxorubicin, has demonstrated improved overall survival compared to doxorubicin alone in advanced soft tissue sarcomas, and is a promising new agent in these tumours," said Robin L. Jones, BSc, MB, MRCP, M.D., consultant medical oncologist and head of the Sarcoma Unit at The Royal Marsden and team leader at The Institute of Cancer Research, London, and an investigator of the JGDG registration trial.

The primary study endpoint was progression-free survival (PFS) and key secondary endpoints included overall survival (OS) and objective response rate (ORR). The EMA previously granted LARTRUVO with Orphan Drug Designation for the treatment of advanced soft tissue sarcoma in the EU.

"With this decision, LARTRUVO is now approved for use in the EU, offering a new treatment option and new hope to soft tissue sarcoma patients in Europe," said Sue Mahony, Ph.D., Lilly senior vice president and president of Lilly Oncology. "This news further reinforces Lilly's ongoing commitment toward these types of rare diseases and the patient populations that are affected around the globe."

"Soft tissue sarcoma is a very complex disease that is very difficult to treat, and there is a significant need for new treatment options," said Markus Wartenberg, president of Sarcoma Patients EuroNet Association. "This advancement in treatment is encouraging and we hope to see more innovations for our patients in the future."

As part of a conditional marketing authorisation, Lilly will need to provide results from an ongoing Phase 3 study. This study, ANNOUNCE, is fully enrolled. Until availability of the full data, the CHMP will review the benefits and risks of LARTRUVO annually to determine whether the conditional marketing authorisation can be maintained.

This is the first marketing authorisation for LARTRUVO in Europe and follows U.S. Food and Drug Administration (FDA) approval in October 2016.

Notes To Editor

About LARTRUVO (olaratumab)LARTRUVO is a PDGFR blocking antibody that specifically binds PDGFR and prevents receptor activation. LARTRUVO exhibits in vitro and in vivo anti-tumour activity against selected sarcoma cell lines and disrupted the PDGFR signaling pathway in in vivo tumour implant models.

The Phase 3 trial of LARTRUVO and doxorubicin in advanced STS, ANNOUNCE, is fully enrolled (ClinicalTrials.gov Identifier: NCT02451943 [https://clinicaltrials.gov/]).

About the JGDG Trial The open-label, randomised Phase 1b/2 study, JGDG, compared olaratumab in combination with doxorubicin chemotherapy to the control arm of doxorubicin alone in patients with unresectable, advanced STS not amenable to curative treatment with surgery or radiotherapy. After confirmation of safety in the Phase 1b portion of the study, 133 doxorubicin-naïve patients were randomised 1:1 in the Phase 2 portion of the study. A total of 66 patients were treated on the olaratumab-doxorubicin arm, and 67 on the control doxorubicin arm. The primary endpoint of the study was PFS. Key secondary endpoints included OS and ORR.

Randomisation was balanced by ECOG performance status, histological tumour type, PDGFR expression and previous lines of treatment.

Patients treated on the olaratumab and doxorubicin arm achieved 6.6 months of median PFS compared to 4.1 months on the control doxorubicin arm (stratified hazard ratio [HR], 95 percent confidence interval [CI]: 0.672 [0.442-1.021]; p=0.0615). The investigator-assessed PFS was confirmed by independent review (HR=0.670; 95 percent CI: [0.04-1.12]; p=0.1208) with a median PFS of 8.2 months vs. 4.4 months. OS was statistically significant, with patients treated on the olaratumab and doxorubicin arm having achieved a median OS of 26.5 months (95 percent CI, 20.9-31.7) compared to 14.7 months (95 percent CI, 9.2-17.1) with doxorubicin (stratified HR, 0.463; 95 percent CI, 0.301-0.710; p=0.0003). The ORR was 18.2 percent (95 percent CI; [9.8-29.6]) with olaratumab plus doxorubicin and 11.9 percent (95 percent CI: [5.3-22.2]) with doxorubicin (p=0.3421).

The most common (greater than 5 percent incidence) grade 3 or higher adverse events identified in the study were neutropenia (53.2 percent on the olaratumab combination arm vs. 32.3 percent on the control doxorubicin arm), anemia (12.5 percent vs. 9.2 percent), fatigue (9.4 percent vs. 3.1 percent) and musculoskeletal pain (8 percent vs. 2 percent). There were no increases in febrile neutropenia (12.5 percent on the olaratumab-doxorubicin arm vs. 13.8 percent on the control doxorubicin arm), infections (7.8 percent vs. 10.8 percent) and patient discontinuations (13 percent vs. 19 percent). Grade 3 or higher infusion-related reactions occurred in 3 percent of patients on the olaratumab-doxorubicin arm vs. 0 percent on the control doxorubicin arm.

About SarcomasSarcomas are a diverse and relatively rare type of cancer that usually develop in the connective tissue of the body, which include fat, blood vessels, nerves, bones, muscles, deep skin tissues and cartilage. Soft tissue sarcoma (STS) is a complex disease with multiple subtypes, making it very hard to diagnose and difficult to treat. For decades, there have been no front-line therapeutic advancements for advanced STS that have improved overall survival. An estimated 23,000 people in the EU will be diagnosed with STS this year.

About Lilly OncologyFor more than 50 years, Lilly has been dedicated to delivering life-changing medicines and support to people living with cancer and those who care for them. Lilly is determined to build on this heritage and continue making life better for all those affected by cancer around the world.

About Eli Lilly and CompanyLilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at www.lilly.com [http://www.lilly.com/] and newsroom.lilly.com/social-channels [http://newsroom.lilly.com/social-channels].

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