After Rova-T Failure, A Look at AbbVie’s Pipeline

On March 22, AbbVie announced that after disappointing Phase II clinical trials, it wasn’t going to ask the U.S. Food and Drug Administration (FDA) for accelerated approval for Rova-T in third-line relapsed/refractory (R/R) small cell lung cancer (SCLC). Investors responded, and shares dropped 12 percent. It also left investors and analysts looking at what else the company has in its pipeline that might bolster the company’s portfolio as its Humira faces biosimilar competition in the U.S.

Although many are now dismissing Rova-T entirely, it may still have a future as part of a combination trial. The drug is being evaluated in combination with Bristol-Myers Squibb’s Opdivo and Yervoy in early-stage trials. However, Keith Speights, with The Motley Fool, thinks AbbVie might have better luck in oncology with Imbruvica. In partnership with Johnson & Johnson, AbbVie made $2.5 billion off the drug, with J&J raking in another $1.9 billion.

Speights writes, “One way for Imbruvica to reach its potential is to succeed in late-stage studies targeting treatment of diffuse large B-cell lymphoma (CLBCL), follicular lymphoma, and pancreatic cancer. Based on previous clinical-study results, Imbruvica appears to have the best chances of success in the DLBCL indication, with more modest prospects in the other two cancer types.”

Two other oncology drugs that have potential for AbbVie include Venclexta, which was approved for chronic lymphocytic leukemia (CLL) with 17p deletion in 2016. The company also is hoping the drug will be approved for relapsing or refractory and first-line CLL, acute myeloid leukemia (AML) and multiple myeloma. The other late-stage cancer drug is veliparib, but it didn’t meet primary endpoints in 2017 in two Phase III trials in squamous non-small cell lung cancer (NSCLC) and triple-negative breast cancer. But additional Phase III trials are ongoing for non-squamous NSCLC, BRCA1/2 breast cancer, and ovarian cancer.

In the immunology area, the company’s upadacitinib and risankizumab are big prospects. Upadacinib is being studied in late-stage trials for psoriatic arthritis and rheumatoid arthritis. Risankizumab has wrapped four late-stage trials for psoriatic arthritis.

Speights writes, “AbbVie could have big winners with both of these drugs. All four of the pivotal studies of risankizumab for treating psoriatic arthritis demonstrated positive results. The company expects to submit the drug for regulatory approval in the first half of 2018.”

Upadacinib did well in two late-stage trials for rheumatoid arthritis and should report data on other trials before the halfway point of the year, with plans to submit it for approval in the second half of this year. And if approved, the drugs have potential for atopic dermatitis, ulcerative colitis and Crohn’s disease.

AbbVie also has an asset outside of oncology and immunology with Neurocrine Biosciences. That’s for elagolix, which had positive trial results in November for endometriosis with associated pain. AbbVie is awaiting FDA approval in the second quarter of this year.

Speights notes, “Perhaps the biggest risk of all with AbbVie’s pipeline is that the company’s management has a tendency to overpromise. For example, AbbVie has talked about peak sales potential for Imbruvica of $7 billion, but the jury is still out on that target. And previous skepticism about AbbVie’s prediction of $5 billion in sales for Rova-T certainly now seems to be justified. Still, AbbVie has a very promising pipeline.”