AstraZeneca ($AZN) has posted another set of negative numbers for the cancer drug it licensed from Array Biopharma ($ARRY). The latest setback saw the MEK 1/2 inhibitor selumetinib fail to improve either progression-free or overall survival in patients with KRAS mutation-positive non-small cell lung cancer (NSCLC).
SELECT-1, the Phase III trial, enrolled 510 patients with locally advanced or metastatic NSCLC and randomized them to receive either selumetinib or a placebo on top of chemotherapy drug docetaxel. AstraZeneca advanced into the trial on the back of Phase II data that showed statistically-significant improvements in progression-free and overall survival, but these findings failed to carry over into the larger trial of selumetinib as a second-line treatment for NSCLC.
AstraZeneca is yet to release a detailed look at the data, but its limited release contains few, if any, reasons to believe the drug has a future in NSCLC. The study missed both its primary endpoint of change in progression-free survival and the key secondary endpoint of overall survival. And, having missed both endpoints, the lung cancer team at AstraZeneca is already looking beyond the MEK 1/2 inhibitor to other, more promising, programs.
“We remain committed to further developing treatments in the lung cancer setting, such as our immunotherapy combinations and targeted EGFR treatments,” AstraZeneca CMO Sean Bohen said in a statement.
If the Phase III data mark the end of the line for selumetinib in NSCLC, the drug is left with two more near-term chances to find its niche. The uveal melanoma opportunity fell through last year when AstraZeneca posted its first Phase III selumetinib fail, but studies assessing its use in differentiated thyroid cancer and genetic disorder neurofibromatosis type 1 are still ongoing.
Those trials now represent Array’s best hopes of seeing royalties from selumetinib within the next few years. Both studies have estimated primary completion dates of late 2017. AstraZeneca is also involved in early-phase studies that are giving selumetinib as part of combinations or in new indications.
But with the second Phase III trial failure in 13 months raising doubts about whether selumetinib will ever come good, investors fled Array, wiping close to 20% off its share price in premarket trading.
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