Two phase 3 trials of AbbVie’s PARP inhibitor veliparib have missed their primary endpoints. The studies set out to show that the addition of veliparib to chemotherapy improves outcomes in patients with non-small cell lung cancer or triple negative breast cancer but fell short of this goal.
AbbVie is saving the full postmortems of the trials for a medical meeting or peer-reviewed paper. But its brief statement on the studies makes it clear the results have dashed hopes of taking the combination of veliparib with carboplatin and paclitaxel any further in the two indications.
“We wanted to explore whether a PARP inhibitor could augment chemotherapy in patients with squamous non-small cell lung cancer and triple negative breast cancer by disrupting the repair of cancer cells," AbbVie VP Gary Gordon, M.D., Ph.D., said in a statement. "Unfortunately, these data do not support the use of veliparib in combination with chemotherapy in these patients."
The 970-patient lung cancer trial assessed the effect of veliparib on overall survival in smokers. The 312-subject breast cancer study looked at the PARP inhibitor’s impact on pathological complete response. Veliparib failed to move the needle in either case.
Analysts at Jefferies were sanguine following the failures, noting that the PARP inhibitor accounted for less than 1% of their midterm revenue forecasts. That modeling makes veliparib a small piece of the late-phase blitz AbbVie has embarked on to equip its business to weather the impact of biosimilar competition for its cornerstone drug Humira.
Other pieces of the strategy are set to hit milestones over the next 12 months. Before the end of 2017, AbbVie is expected to present small cell lung cancer data on Rova-T that will give a read on whether it was wise to spend upward of $5.8 billion on Stemcentrx. The drugmaker is also expected to present results that will start to reveal the merits of its decision to push Galapagos into the arms of Gilead and forge ahead with its own JAK1 inhibitor ABT-494.
AbbVie is also barrelling toward readouts from other trials of veliparib, but the failures of the first two studies have dampened expectations. If those trials also fall short, AbbVie will cede the PARP market to a clutch of other drugmakers. Tesaro joined AstraZeneca and Clovis on the list of companies with approved PARP inhibitors last month. And the trio could be joined by Pfizer once it has data on the drug it gained in the $14 billion buyout of Medivation.