European Business
  • HOME
  • SUSTAINABILITY
  • INVEST
  • MARKET
  • PARTNERSHIP
  • INNOVATION
  • PEOPLE
  • INSIGHTS
No Result
View All Result
European Business
  • HOME
  • SUSTAINABILITY
  • INVEST
  • MARKET
  • PARTNERSHIP
  • INNOVATION
  • PEOPLE
  • INSIGHTS
No Result
View All Result
European Business
No Result
View All Result
Home < INDUSTRIES Health

Lilly Presents Updated Data on Retevmo® (selpercatinib) in Advanced RET Fusion-Positive Non-Small-Cell Lung Cancer (NSCLC) at the 2022 European Lung Cancer Congress

by Alex Weber
April 2, 2022
A A
Share on LinkedinShare on Twitter

Eli Lilly and Company (NYSE: LLY) today announced updated data from the Phase 1/2 LIBRETTO-001 trial of Retevmo® (selpercatinib 40 mg & 80 mg capsules) in patients with RET fusion-positive non-small cell lung cancer (NSCLC). Retevmo (marketed as Retsevmo® outside of the U.S.) is a selective and potent RET kinase inhibitor that is approved in multiple countries including the United States for treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive NSCLC, and the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy, or advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). These data were presented at the European Lung Cancer (ELCC) 2022 (poster 27p).

“The LIBRETTO trial provides the largest set of clinical data for a RET inhibitor and these results continue to demonstrate evidence of meaningful clinical outcomes for patients with metastatic RET fusion-positive NSCLC treated with Retevmo, including those with difficult-to-treat brain metastases,” said David Hyman, M.D. chief medical officer, oncology at Lilly. “We are continuing to build on the robust body of evidence supporting Retevmo, including through an ongoing randomized Phase 3 confirmatory study, with a planned readout in 2023.”

The updated analysis utilized a June 15, 2021, data cut-off and included 355 patients who were eligible for efficacy analysis, 247 of which were previously treated with at least one line of platinum chemotherapy and 69 of which were treatment-naïve. Patients who were previously treated with at least one line of platinum chemotherapy received a median of two prior treatment regimens (range: 1-15), with 58% having received anti-PD-1 or anti-PD-L1 therapy. Responses are based on independent review committee (IRC) assessment.

Among 247 patients previously treated with platinum chemotherapy, the confirmed objective response rate (ORR) was 61.1% (95% CI: 54.7-67.2%) and among 69 treatment-naïve patients, the confirmed ORR was 84.1% (95% CI: 73.3-91.8%). Twenty-six patients had measurable central nervous system (CNS) metastases at baseline and treatment with Retevmo resulted in a CNS ORR of 84.6%, with 22 patients having a confirmed best response of complete response or partial response.  

At a median follow-up of approximately two years in both the treatment-naïve and platinum-chemotherapy pretreated populations, median duration of response (DoR) is estimated at 20.2 (55.2% censoring rate; 20.3 months median duration of follow-up) and 28.6 (60.9% censoring rate; 21.2 months median duration of follow-up) months, respectively and median progression free survival (PFS) is estimated at 22.0 (53.6% censoring rate; 21.9 months median duration of follow-up) and 24.9 (55.9% censoring rate; 24.7 months median duration of follow-up) months, respectively. Of the 26 patients with measurable CNS disease, Retevmo treatment resulted in a median intracranial PFS of 19.4 months. These median estimates remain immature.

Safety among patients in this cohort was consistent with the known safety profile of Retevmo. In the safety population (all NSCLC patients that received at least one dose of Retevmo, N=356), the most common adverse events (AEs in ?25% of patients) were dry mouth, diarrhea, hypertension, increased ALT/AST, peripheral edema, constipation, rash, headache, and fatigue.  Thirty-four patients discontinued due to an adverse event (10%), eleven (3%) of which were deemed related to Retevmo.

A global, randomized, Phase 3 trial is currently recruiting and will compare treatment with Retevmo to the current standard of care in the first-line treatment of advanced or metastatic RET fusion-positive NSCLC.

Retevmo was the first RET inhibitor to receive Accelerated Approval from the U.S. Food and Drug Administration (FDA) in May 2020 and was the first approved by the European Commission in February 2021. Retevmo was approved under the FDA’s Accelerated Approval regulations based on the LIBRETTO-001 Phase 1/2 trial’s endpoints of objective response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Tags: < New Launches

Related Industries

Health

Interview with Mr. Sébastien Huron, CEO, Virbac group

March 6, 2023
Health

Bayer driving innovation in radiology with new research across the portfolio presented at ECR

February 23, 2023
Health

Philips recognized as top innovator for 10th consecutive year

February 17, 2023
Health

Bayer completes acquisition of Blackford Analysis Ltd.

February 14, 2023
Health

Sandoz announces agreement to acquire leading antifungal agent Mycamine® from Astellas, reinforcing hospital offering and leading Anti-Infectives portfolio

January 25, 2023
Health

Aleksandra Rizo Appointed as CEO of Vividion Therapeutics

January 25, 2023

Change in top management at Lufthansa Group and Lufthansa Airlines

February 23, 2023

...

Xiaomi Begins Product Carbon Footprint Assessment and Champions Sustainable Living Awareness

February 27, 2023

...

CHANGES IN HOLCIM’S BOARD OF DIRECTORS LEADERSHIP

February 25, 2023

...

GE Renewable Energy continues to add wind power to Lithuania

March 3, 2023

...

UBS to acquire Credit Suisse

March 20, 2023

...

Amazon pays millions of euros in corporate tax across Europe

March 8, 2023

...

Introducing the Aygo X UNDERCOVER

March 3, 2023

...

ABN AMRO Sustainable Impact Fund invests in Fairphone

February 25, 2023

...

Amazon named as a “Top Employer 2023” in Europe

March 1, 2023

...

A new dawn for the magnificent Grand Dame of La Croisette as Carlton Cannes, A Regent Hotel is poised to return

March 11, 2023

...

Asia Pacific Business Asia Pacific Business Asia Pacific Business

EUROPEAN BUSINESS is a premier source of corporate news, business information and insights across broad spectrum of industries in Europe and worldwide.  We are one of the members of the Business World Network.

RESOURCES

  • HOME
  • SUSTAINABILITY
  • INVEST
  • MARKET
  • PARTNERSHIP
  • INNOVATION
  • PEOPLE
  • INSIGHTS

CONTACT US

EDITORIAL:     editor # european-biz.com

PARTNERSHIP:     partnership # european-biz.com

HUMAN RESOURCE:     hr # european-biz.com

* (replace # with @)

  • Official Site

Copyright © EUROPEAN-BIZ.COM All rights reserved.

No Result
View All Result
  • HOME
  • SUSTAINABILITY
  • INVEST
  • MARKET
  • PARTNERSHIP
  • INNOVATION
  • PEOPLE
  • INSIGHTS

Copyright © EUROPEAN-BIZ.COM All rights reserved.

Welcome Back!

Login to your account below

Forgotten Password?

Retrieve your password

Please enter your username or email address to reset your password.

Log In

Add New Playlist