FDA Fast Tracks MYTX-011 for Patients with NSCLC and cMET Overexpression


The investigational antibody-drug conjugate, MYTX-011, is one step further in development for the treatment of non–small cel lung cancer with cMET overexpression.

  • A fast track designation (FTD) for MYTX-011 will expedite the regulatory filing path for Mythic Therapeutics.1

  • Based on this designation, MYTX-011 has potential to fill an unmet medical need for patients with non­–small cell lung cancer (NSCLC) and cMET overexpression.

  • If later granted FDA approval, MYTX -01 would be the first therapy approved for patients with NSCLC and cMET overexpression.

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The FDA has granted FTD to MYTX-011 for the treatment of patients with NSCLC whose tumors overexpress cMET, including those whose overexpression is low and intermediate.1

MYTX-011 is a next-generation, cMET-targeting antibody-drug conjugate (ADC), which creates an atmosphere for ADC to actively move through cells and increase the amount of therapy being delivered, with less of an effect on healthy cells. According to Nimish Gera, PhD, et al, MET alterations can be key oncogenic drivers in NSCLC.2 Although cMET0-targeting ADCS have predominantly shown efficacy in patients with the highest cMET overexpression levels, the innovative FateControl™ technology from Mythic Therapeutics offers a new approach.

“While a small fraction of NSCLC tumors highly express cMET, a much broader patient population have tumors which overexpress cMET, but at lower levels,” said KisMET-01 study investigator Rebecca Heist, MD, MPH, associate professor of medicine at Harvard Medical School and Lee Albright and Nile Albright MD Endowed Chair in Clinical Cancer Research at Massachusetts General Hospital, in a press release. “It’s important we continue investigating the potential of MYTX-011 for patients with NSCLC who need new approaches to treating their cancer as many either do not respond to, or develop resistance to, existing treatment options.”

About the Phase 1 KisMET-01 Study

Trial Name: A Phase 1 Multicenter Dose Escalation and Dose Expansion Study of Antibody-Drug Conjugate MYTX-011 in Subjects With Non-Small Cell Lung Cancer - KisMET-01

ClinicalTrials.gov Identifier: NCT05652868

Sponsor: Mythic Therapeutics

Recruitment Contact: Michelle Hylan or Lisa Haystrand, 1-833-888-1138, clinicalsupport@mythictx.com

Completion Date: December 2027

MYTX-011 is now under investigation in a phase 1, multicenter, dose-escalation and dose-expansion study (KisMET-01; NCT05652868).1,3 The first patient in the study was dosed with MYTX-011 in April 2023.4

KisMET-01 is investigating the safety, tolerability, pharmacokinetics, and preliminary activity of MYTX-011 in advanced NSCLC with the coprimary end points of dose-limiting toxicities and tumor response. The secondary end points of the study are pharmacokinetics, presence of anti-drug antibodies, objective response rate, duration of response, progression-free survival, and overall survival.3

One-hundred fifty patients with advanced NSCLC are expected to be enrolled in the study. During part 1, the dose-escalation phase, treatment with MYTX-011 will be administered intravenously every 21 days for up to 2 years. During part 2, the dose-expansion phase, patients will receive 2 different doses of the agent, following the same dosing schedule as part 1. Following the dose-expansion phase, patients will be administered the recommended phase 2 dose of MYTX-011.

Patients eligible to enroll in the study are those who have histologically or cytologically confirmed disease, a measurable lesion per RECIST 1.1, and an ECOG performance status of 0 or 1. The study excludes patients who had radiation to the lung within 2 months before screening, or major surgery within 28 days of the first MYTX-011 dose. Patients are also excluded if they have untreated or uncontrolled central nervous system metastases, history of interstitial lung disease or pneumonitis, clinically significant illness that poses a risk, grade 1 neuropathy, history of cirrhosis, haptic fibrosis, esophageal or gastric varices, or other liver disease, or those with active or chronic corneal disorder.

“Receiving fast track designation from the FDA reinforces our focus on addressing the unmet need of patients living with cMET-positive NSCLC, who currently have few effective treatments,” said Brian Fiske, PhD, chief scientific officer and co-founder at Mythic Therapeutics, in the press release.1


1. Mythic Therapeutics receives FDA fast track designation for mytx-011 for patients with non-small cell lung cancer (NSCLC) with cMET overexpression. News release. Mythic Therapeutics. September 26, 2023. Accessed September 26, 2023. https://tinyurl.com/2yy8j9mx

2. Gera N, Fitzgerald K, Ramesh V, et al. Abstract 5000: MYTX-011: A novel cMET-targeting antibody drug conjugate (ADC) engineered to increase on-target uptake in and efficacy against cMET expressing tumors. Cancer Res. 2023;83(suppl 7): 5000. doi:10.1158/1538-7445.AM2023-5000

3. Clinical study of antibody-drug conjugate MYTX-011 in subjects with non-small cell lung cancer. ClinicalTrials.gov. Updated September 26, 2023. Accessed September 26, 2023. https://tinyurl.com/p6uhk75x

4. Mythic Therapeutics announces first subject dosed in phase 1 kismet-01 clinical trial of cmet-targeting antibody-drug conjugate (ADC) MYTX-011 for the treatment of non-small cell lung cancer (NSCLC). News release. Mythic Therapeutics. April 4, 2023. Accessed September 26, 2023. https://tinyurl.com/22cjz5uj

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