SARMs: enobosarm's two phase 3 trials in lung-cancer muscle wasting missed their agreed endpoints

Source: GTx, Inc. press release (Business Wire), Aug 19, 2013, via Fierce Biotech

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“the clinical trials failed to meet the overall criteria for the co-primary responder endpoints of lean body mass and physical function”

Evidence level

Company announcement of two randomized, double-blind, placebo-controlled phase 3 trials (about 325 patients each).

Funding

Industry: sponsored by GTx.

What was published

Top-line results of the POWER1 and POWER2 trials of enobosarm 3 mg in non-small cell lung cancer patients starting chemotherapy.

What it shows

The trials "failed to meet the overall criteria for the co-primary responder endpoints of lean body mass and physical function." An exploratory analysis showed a "consistent effect on LBM" in both trials; stair-climb results were "inconsistent."

What it does not show

Muscle gain was not shown to improve physical function or survival; the company's survival link is exploratory.

Documented counterpoints

GTx's CEO said the company was "encouraged by the unambiguous effect of enobosarm on muscle." No regulator approved enobosarm for muscle wasting; the drug remains unapproved.

Source link

Fierce Biotech (GTx press release)

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