G1 Therapeutics has entered a clinical trial collaboration to assess its G1T38 in combination with AstraZeneca’s Tagrisso (osimertinib) in a Phase Ib/II clinical trial to treat patients suffering from EGFR mutation-positive non-small cell lung cancer (NSCLC).

G1T38 is an investigational, oral CDK4/6 inhibitor designed to be used along with other targeted therapies for various oncology indications.

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Tagrisso is an irreversible inhibitor of epidermal growth factor receptor (EGFR) tyrosine kinase developed to block EGFR-sensitising and EGFR T790M-resistance mutations.

The drug possesses clinical activity against central nervous system (CNS) metastases and its once-a-day 40mg and 80mg oral doses have been approved in more than 60 countries for EGFR T790M mutation-positive advanced NSCLC.

As per the agreement, G1 will conduct and fund the Phase Ib/II trial in alliance with AstraZeneca for subjects who have the EGFR T790M mutation and progressed on first-line EGFR inhibitors.

“CDK4/6 inhibitors can enhance the efficacy of targeted therapies, and G1T38 has already shown encouraging preclinical and initial clinical data that support a potential best-in-class profile.”

G1 Therapeutics CEO Mark Velleca said: “CDK4/6 inhibitors can enhance the efficacy of targeted therapies, and G1T38 has already shown encouraging preclinical and initial clinical data that support a potential best-in-class profile.

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“The addition of G1T38 to Tagrisso in EGFR mutation-positive non-small cell lung cancer has the potential to prolong the time to disease progression by overcoming resistance mechanisms.”

Scheduled to be initiated in the first quarter of next year, the trial’s Phase Ib part will determine the recommended Phase II dose of G1T38 when combined with Tagrisso.

In the Phase II part, progression-free survival will be compared between the combination and Tagrisso monotherapy in a total of 108 patients.