AstraZeneca and Incyte to evaluate combination drug in Phase I/II lung cancer trial

11th January 2016 (Last Updated January 11th, 2016 18:30)

AstraZeneca and Incyte are collaborating on a trial evaluating a new combination drug to treat lung cancer.

AstraZeneca and Incyte are collaborating on a trial evaluating a new combination drug to treat lung cancer.

The firms will collaborate on a Phase I / II trial, which will be conducted by Incyte.

The trial is designed to evaluate the efficacy and safety of Incyte's Janus-associated kinase (JAK) 1 inhibitor, INCB39110, in combination with AstraZeneca's next-generation epidermal growth factor receptor (EGFR) inhibitor, Tagrisso (osimertinib).

The combination will be evaluated as a second line treatment for patients with EGFR mutation-positive non-small cell lung cancer (NSCLC), who have been treated with a first generation EGFR tyrosine kinase inhibitor (TKI) and subsequently developed the T790M resistance mutation.

"This collaboration allows us to explore further ways in which Tagrisso, our first in class T790M-directed tyrosine kinase inhibitor, can help meet urgent unmet patient need."

The trial's Phase I is expected to establish a recommended dose regimen for the combination, while Phase II will evaluate its safety and efficacy.

Results from the trial will be used to determine whether further clinical development of the combination is warranted.

AstraZeneca Oncology, Global Medicines Development head Antoine Yver said: "We are pleased to be building on our existing relationship with Incyte and exploring a potentially exciting combination for lung cancer patients who have developed a resistance to first generation EGFR inhibitor treatment.

"This collaboration allows us to explore further ways in which Tagrisso, our first in class T790M-directed tyrosine kinase inhibitor, can help meet urgent unmet patient need, following its accelerated approval in the US and the recent positive CHMP opinion, recommending approval in Europe."

There is increasing evidence that signalling through the JAK-STAT pathway could be a contributing factor in resistance to EGFR TKI treatment in patients with EGFR mutation NSCLC.

Blocking both JAK and EGFR activity may offer an improved, targeted treatment benefit in some patients.

The new agreement builds on an existing collaboration between the two companies signed in May 2014, which explored AstraZeneca's anti-PD-L1 immune checkpoint inhibitor, durvalumab, in combination with Incyte's oral indoleamine dioxygenase-1 (IDO1) inhibitor, epacadostat (INCB24360).

AstraZeneca's Tagrisso is the only approved medicine indicated for adult patients with metastatic EGFR T790M mutation-positive NSCLC.

This indication is approved under the US Food and Drug Administration (FDA's) accelerated approval process based on tumour response rate and duration of response (DoR).

Osimertinib is currently being compared with platinum-based doublet chemotherapy in the confirmatory AURA3 Phase III trial in patients with EGFR T790M-positive, locally advanced, or metastatic NSCLC who have progressed after EGFR-TKI therapy.