AstraZeneca has started the randomised, double-blind, placebo-controlled Phase III clinical study of its oral, potent, selective MEK inhibitor selumetinib as second-line therapy to treat patients with advanced non-small-cell lung cancer (NSCLC) tumours.
The ‘SELumetinib Evaluation as Combination Therapy-1’ (SELECT-1) study is intended to assess the safety and efficacy of selumetinib plus docetaxel to treat patients who are KRAS mutation-positive, a sub-type of lung cancer related with poor prognosis and limited treatment options.
The SELECT-1 study is designed to evaluate progression free survival (PFS) and overall survival (OS).
Some 630 patients will be enrolled in the trial who will be given either a twice-daily 75mg dose of selumetinib or placebo in combination with docetaxel, administered intravenously on a 21-day cycle.
Selumetinib was progressed into Phase III trials based on positive Phase II results, which showed selumetinib plus docetaxel increased progression free survival (PFS) by 3.2 months compared with docetaxel alone in KRAS-mutation positive NSCLC.
AstraZeneca Global Medicines Development unit vice-president and head of oncology Antoine Yver said SELECT-1 is expected to be the first Phase III study to investigate whether a MEK inhibitor in combination with chemotherapy is superior to chemotherapy alone in KRAS mutation positive advanced or metastatic non-small cell lung cancer.
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"This is an area of pressing clinical need, and our decision to progress selumetinib was based on Phase II results, which showed promising clinical activity in this group of patients," Yver said.
Mitogen-activated protein kinase (MEK) is part of the MAPK pathway that is frequently activated in cancer and is elevated in many different solid tumour types, including those featuring the KRAS mutation, which is present in 20%-30% of NSCLC tumours.
In previously conducted Phase I and Phase II clinical trials across a range of solid tumours, Selumetinib demonstrated its effectiveness as monotherapy and in combination with standard chemotherapy regimens supporting its development in patients with MEK-dependent cancers.
The drug is also being studied across a range of other MEK-dependent cancers and the company carried out a Phase II study of selumetinib in thyroid cancer in August.
Before the end of this year, the company intends to start a Phase II study to evaluate the clinical efficacy and tolerability in combination with dacarbazine in patients with the rare cancer metastatic uveal melanoma.
In 2003, the company secured exclusive worldwide rights of selumetinib from Array BioPharma.
Image: Micrograph of squamous carcinoma, a type of non-small-cell carcinoma. Photo: courtesy of Nephron.