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AbbVie Inc.’s latest clinical trial data, for the lung cancer drug Rova-T, hardly wowed investors and industry observers on Thursday.
They were even less impressed upon noticing an important disclosure, reduced to a footnote: “Data represent 74 percent of the TRINITY study population with high DLL3 expression.”
Patients in the phase 2 trial had already been selected because of DLL3 expression, since Rova-T specifically targets that protein.
But AbbVie’s ABBV, -12.03% release honed in further, on patients with high DLL3 expression, and even then could only report less-than-stellar results.
Critics called foul — or rather, cherry-picking. (AbbVie did not immediately return MarketWatch’s request for comment.)
Putting an important disclosure in a footnote is something a “tiny, shady biotech would do. Especially from a company like AbbVie, you should never have to read a footnote to get the full story,” cancer research expert Brad Loncar told MarketWatch.
AbbVie shares plummeted 12.5% in extremely heavy Thursday trade, putting them on track for the biggest one-day percentage decline since the stock went public in 2012.
The company’s second-biggest stock decline was a 10.3% drop in 2015, after the FDA warned that two AbbVie hepatitis C treatments can cause serious liver injury.
Read: AbbVie stock slammed after disappointing results for cancer drug acquired in $5.8 billion deal
Important footnote to the 16% ORR in Trinity, implying >50% (?) DLL3 expressing subgroup. So the ITT result (>1%) will be even worse... $ABBV pic.twitter.com/8wI20szkN9
— Jacob Plieth (@JacobPlieth) March 22, 2018
A great point. Even large pharma can be guilty of putting lipstick on a pig through datamining $ABBV https://t.co/P5PNGe8HGi
— Maxim Jacobs, CFA (@MaxJacobsEdison) March 22, 2018
In cancer trials, overall response rates measure the percentage of patients whose cancer responds to the therapy.
Rates are determined both by the trial’s investigators and by independent review committees, with the latter considered a more important measurement.
See: Multimillion-dollar drug yanked from market connected to dangerous brain inflammation cases in U.S.
Of 177 patients, the best overall response rate — as measured by trial investigators — was 29%.
Objective response rate, measured by an independent review committee, was just 16%, with a median duration of 4.1 months. (Approval typically requires around 30% or 40%.)
Including the full patient population in those figures would likely have resulted in poorer rates, critics said.
AbbVie shares have plummeted 14.9% month-to-date, compared with a 1.2% decline in the S&P 500 SPX, -1.38%