Data in The Lancet Show Olaratumab Plus Doxorubicin Offered 11.8-Month Increase in Overall Survival in Patients with Advanced Soft Tissue Sarcoma, as Reported by Lilly and Memorial Sloan Kettering Researchers
"Olaratumab is the first agent added to doxorubicin to demonstrate improved overall survival in advanced soft tissue sarcoma in a randomized trial," said
The open-label, randomized 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 randomized 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 placebo-doxorubicin arm. The primary endpoint of the study was PFS. Key secondary endpoints included OS and objective response rate (ORR).
Randomization was balanced by ECOG performance status, histological tumor 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 placebo and 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).
"We are encouraged to see the positive progression-free survival results and the increase in overall survival, which is something we haven't seen in combination or against doxorubicin in the advanced soft tissue sarcoma setting in decades," said
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 placebo plus 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 placebo-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 placebo-doxorubicin arm.
Lilly has submitted the results of this study to the
Sarcomas 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 difficult to treat. According to the
Olaratumab is a human IgG1 monoclonal antibody that is designed to disrupt the PDGF Receptor-α (platelet-derived growth factor receptor α) pathway on tumor cells and on cells in the tumor microenvironment. This means it may cause anticancer activity by targeting tumor cells directly, as well as cells that surround and support tumor growth.
About Lilly Oncology
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Lilly Forward-Looking Statement
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about the potential of olaratumab as a potential treatment of advanced soft tissue sarcoma and reflects Lilly's current beliefs. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the study findings to date or that olaratumab will receive regulatory approval or that, if approved, it will prove to be commercially successful. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, please see the company's latest Forms 10-K and 10-Q filed with the
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