Phase 2 trial evaluating the safety and efficacy of luvelta in adult patients with previously treated advanced or metastatic NSCLC with FRα expression ≥25% Tumor Proportion Score (TPS)

Lung cancer is the leading cause of cancer-related deaths worldwide1.

» ClinicalTrials.gov Identifier: NCT06555263

FRα has been found in multiple cancer types including NSCLC, but exhibits limited expression in normal tissue2,3,4.

Approximately 30% of patients with adenocarcinoma NSCLC have FRα expression, making FRα an attractive therapeutic target for treatment of advanced NSCLC and providing patients an opportunity for a targeted therapy.

 

“The initiation of REFRαME-L1 is an important milestone in our efforts to expand the application of luvelta to a broad range of patients with FRα expressing cancers.”

Anne Borgman, M.D., Chief Medical Officer

IMPORTANT INFORMATION ABOUT THE STUDY

ARE YOU ABLE TO JOIN THE REFRαME-L1 STUDY?

To qualify for REFRɑME-L1, patients must meet the following criteria:

  • Stage IIIb/c or Stage IV lung cancer (adenocarcinoma or adenosquamous subtype)
  • Have received between 2 and 4 prior treatments for lung cancer
  • 25% to 100% of your cancer cells express Folate Receptor Alpha (FRα) (your doctor will conduct this test)

    WHAT MEDICINES WILL YOU RECEIVE?

    Participants may receive the investigational treatment, luveltamab tazevibulin.

    WHAT SHOULD YOU EXPECT DURING THE STUDY IF YOU ENROLL? 

    Throughout the study, your doctors will monitor your health with regular blood tests and imaging. They will also follow up with you if you decide to discontinue treatment.

    WHY IS THE REFRαME-L1 STUDY UNIQUE?

    There are currently no approved FRα-directed therapies for NSCLC. Luveltamab tazevibulin may become the first such treatment for this condition.

    WHO IS SUTRO?

    Sutro Biopharma is an innovative drug company that designs and develops targeted cancer medicines for patients who need them the most

    Discuss with your doctors the potential risks and benefits of participating in REFRαME-L1 to determine if it is suitable for you.

    More information about Sutro and their studies can be found at sutrobio.com or email us directly at lung@sutrobio.com

    References: 1. Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. Cancer J Clin. 2021;71(3):209. 2. Cheung A, Bax HJ, Josephs DH, Smith J, Jones A, Lewis K, et al. Targeting folate receptor alpha for cancer treatment. Oncotarget. 2016;7(32):52553-52574. 3. Nunez MI, Behrens C, Woods DM, Lin H, Suraokar M, Kadara H, et al. High expression of folate receptor alpha in lung cancer correlates with adenocarcinoma histology and EGFR [corrected] mutation. J Thorac Oncol. 2012;7 4. 833-40. Erratum in: J Thorac Oncol. 2012 Jun;7(6):1065.