Turning Point Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for Combination of Elzovantinib and Aumolertinib in EGFR Mutant Met-Amplified Non-Small Cell Lung Cancer
Turning Point Therapeutics (TPTX) has received FDA clearance for its Investigational New Drug (IND) application concerning the combination of elzovantinib and aumolertinib in treating EGFR mutant MET-amplified advanced non-small cell lung cancer (NSCLC). The company plans to initiate the Phase 1b/2 SHIELD-2 trial in mid-2022, which will evaluate safety and preliminary efficacy in patients previously treated with osimertinib. Aumolertinib is already approved in China for specific NSCLC treatments. This development may enhance anti-tumor activity and address resistance issues in a subset of lung cancer patients.
- FDA clearance for elzovantinib and aumolertinib combination therapy.
- Initiation of Phase 1b/2 SHIELD-2 study aims to explore this combination's clinical benefits.
- Aumolertinib is already approved in China, potentially enhancing the trial's credibility.
- Pending results from the SHIELD-2 trial introduce uncertainty regarding the therapy's efficacy.
- Combination therapy's potential risks and side effects are unknown until trial completion.
SAN DIEGO, Jan. 20, 2022 (GLOBE NEWSWIRE) -- Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, today announced that the company has received clearance from the FDA for the company’s Investigational New Drug (IND) application for the combination of elzovantinib and aumolertinib in EGFR mutant MET-amplified advanced non-small cell lung cancer (NSCLC). The company expects to initiate the Phase 1b/2 SHIELD-2 combination study in mid-2022.
Aumolertinib is EQRx’s third generation EGFR inhibitor which is approved in China for first line treatment of EGFR mutant NSCLC and second line treatment of T790M+ EGFR mutant NSCLC. The combination of elzovantinib and aumolertinib will be studied in this Phase 1b/2 trial in patients with EGFR mutant MET-amplified advanced NSCLC who have progressed following treatment with osimertinib. The study will evaluate the safety, tolerability and preliminary efficacy of the combination regimen.
Preclinical data suggest the combination of MET and EGFR inhibition has the potential to increase anti-tumor activity based on complementary mechanisms. It is estimated that 15 to
“We are pleased with the clearance of this IND,” said Mohammad Hirmand, M.D., Executive Vice President and Chief Medical Officer. “We look forward to initiating the trial in mid-2022 and exploring the potential clinical benefits of this investigational combination therapy.”
About Turning Point Therapeutics Inc.
Turning Point Therapeutics is a clinical-stage precision oncology company with a pipeline of internally discovered investigational drugs designed to address key limitations of existing cancer therapies. The company’s lead drug candidate, repotrectinib, is a next-generation kinase inhibitor targeting the ROS1 and TRK oncogenic drivers of non-small cell lung cancer and advanced solid tumors. Repotrectinib, which is being studied in a registrational Phase 2 study in adults and a Phase 1/2 study in pediatric patients, has shown antitumor activity and durable responses among kinase inhibitor treatment-naïve and pre-treated patients. The company’s pipeline of drug candidates also includes elzovantinib, targeting MET, CSF1R and SRC, which is being studied in a Phase 1 trial of patients with advanced or metastatic solid tumors harboring genetic alterations in MET; TPX-0046, targeting RET, which is being studied in a Phase 1/2 trial of patients with advanced or metastatic solid tumors harboring genetic alterations in RET; and TPX-0131, a next-generation ALK inhibitor, which is being studied in a Phase 1/2 trial of previously treated patients with ALK-positive advanced or metastatic non-small cell lung cancer. The company is driven to develop therapies that mark a turning point for patients in their cancer treatment. For more information, visit www.tptherapeutics.com.
Forward Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “plans”, “will”, “believes,” “anticipates,” “expects,” “intends,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and therapeutic potential of Turning Point Therapeutics’ drug candidate elzovantinib and the results, conduct, progress and timing of the planned SHIELD-2 clinical study. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon Turning Point Therapeutics’ current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Turning Point Therapeutics’ business in general, risks and uncertainties related to the impact of the COVID-19 pandemic to Turning Point Therapeutics’ business and the other risks described in Turning Point Therapeutics’ filings with the SEC, including its quarterly report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 9, 2021. All forward-looking statements contained in this press release speak only as of the date on which they were made. Turning Point Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
Contact:
Adam D. Levy, PhD, MBA
adam.levy@tptherapeutics.com
858-867-6366
FAQ
What is the significance of TPTX's IND clearance?
When will TPTX's SHIELD-2 study begin?
What is aumolertinib's current approval status?
What patient population is the SHIELD-2 study targeting?
