Phase III trials show no increase in clinical benefit
AbbVie's hopes of launching a fourth PARP inhibitor onto the market have been dashed by two failed phase III trials for its veliparib candidate.
The studies were looking at the use of veliparib alongside chemotherapy in patients with non-small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC), but adding the PARP inhibitor in both cases provided no increase in clinical benefit over chemotherapy alone.
AbbVie stopped short of saying it was the end for veliparib just yet, saying that it will present the data from the studies at future medical congresses. The company still has a phase III trial ongoing in ovarian cancer but that is not due to complete until 2019 and the failure in lung and breast cancer dramatically diminishes any potential sales for the drug.
The current crop of PARP inhibitors - AstraZeneca's Lynparza (olaparib), Clovis Oncology's Rubraca (rucaparib) and Tesaro's Zejula (niraparib) - are already approved for ovarian cancer and AbbVie had been hoping that initial approvals in lung and breast cancer indications would sidestep that competition.
"In these clinical trials we wanted to explore whether a PARP inhibitor could augment chemotherapy…by disrupting the repair of cancer cells," said Gary Gordon, vice president of oncology clinical development at AbbVie. "Unfortunately, the data does not support the use of veliparib in combination with chemotherapy in these patients."
The company is already pointing to its ‘robust pipeline’ in oncology as it tries to diversify and reduce its reliance on $16bn-a-year immunology blockbuster Humira (adalimumab), and according to analysts at Jefferies veliparib was only seen as a minor component of that effort given the increasingly crowded PARP inhibitor market.
That market could see another competitor soon in the shape of Pfizer's talazoparib acquired as part of its $14bn purchase of Medivation last year, assuming Pfizer's drug can succeed in late-stage trials where veliparib as so far failed.
AbbVie will draw comfort from its stake in three fast-growing blood cancer drugs - Imbruvica (ibrutinib), Venclexta (venetoclax) and Empliciti (elotuzumab) - and several mid-stage candidates including antibody drug conjugates (ADCs) Rova-T for small cell lung cancer (SCLC) and ABT-414 for the brain cancer glioblastoma.