Lartruvo
Oncology· 61 cited findings· 1 source document
Company: Eli Lilly and Company →
What the regulatory reviews say
Lartruvo (olaratumab) received accelerated approval on July 10, 2017, for the treatment of adult patients with soft tissue sarcoma (STS). It is indicated, in combination with doxorubicin, for 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. The approval was based on a trial where patients were randomized to either the Lartruvo + doxorubicin arm (66 patients) or the doxorubicin arm (67 patients).
In terms of efficacy, the Overall Survival for the Lartruvo + Doxorubicin arm was 26.5 months, compared to 14.7 months for the Doxorubicin arm, with an Overall Survival Hazard Ratio of 0.52 (p<=0.05). Progression-Free Survival was 8.2 months for the Lartruvo + Doxorubicin arm versus 4.4 months for the Doxorubicin arm, with a Hazard Ratio of 0.74. The Objective Response Rate was 18.2% for the Lartruvo + Doxorubicin arm and 7.5% for the Doxorubicin arm.
Regarding safety, the infusion-related reactions (IRR) rate was 14%, with a Grade >=3 IRR rate of 2.3%. IRR led to permanent discontinuation in 2.3% of patients and infusion interruption in 10%. The median duration of exposure to Lartruvo was 6 months.
Key figures — cited to the source page
| Overall Survival (LARTRUVO + Doxorubicin arm) | 26.5 months | ELI LILLY AND CO — Lartruvo FDA Review (NDA/BLA 761038, 2019, p.7 |
| Overall Survival (Doxorubicin arm) | 14.7 months | ELI LILLY AND CO — Lartruvo FDA Review (NDA/BLA 761038, 2019, p.7 |
| Overall Survival Hazard Ratio | 0.52 | ELI LILLY AND CO — Lartruvo FDA Review (NDA/BLA 761038, 2019, p.7 |
| Progression-Free Survival (LARTRUVO + Doxorubicin arm) | 8.2 months | ELI LILLY AND CO — Lartruvo FDA Review (NDA/BLA 761038, 2019, p.7 |
| Progression-Free Survival (Doxorubicin arm) | 4.4 months | ELI LILLY AND CO — Lartruvo FDA Review (NDA/BLA 761038, 2019, p.7 |
| Infusion-related reactions (IRR) rate | 14 % | ELI LILLY AND CO — Lartruvo FDA Review (NDA/BLA 761038, 2019, p.7 |
| Grade >=3 IRR rate | 2.3 % | ELI LILLY AND CO — Lartruvo FDA Review (NDA/BLA 761038, 2019, p.7 |
| Approval Date | July 10, 2017 | ELI LILLY AND CO — Lartruvo FDA Review (NDA/BLA 761038, 2019, p.1 |
Source documents
Explore the full evidence
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Figures are as stated in the cited regulatory review documents (different drugs are studied in different trials — values are not head-to-head comparisons). Educational reference only — not medical or investment advice.