Dive Brief:

Positive results from three major trials could position AbbVie and Johnson & Johnson's blood cancer medicine Imbruvica to unseat standard chemotherapy regimens in younger and fitter patients with chronic lymphocytic leukemia (CLL).

Most notable of the three studies were data from a study sponsored by the ECOG-ACRIN Research Group which showed Imbruvica reduced the risk of disease progression or death by 65% compared to a chemo regimen known as FCR in previously untreated patients aged 70 years and younger.

The data, which were presented at the American Society of Hematology's annual meeting earlier this week, could prove to be a commercial boon to Imbruvica's makers, both of whom are counting on the drug to drive cancer sales.

Dive Insight:

Approved since 2013, Imbruvica (ibrutinib) has become a standard treatment in CLL. Use, however, has been greatest in elderly or less fit patients who are unable to tolerate the toxicities of standard chemotherapy regimens.

The results at ASH could change that, proving Imbruvica's progression-free survival benefit over FCR chemotherapy as well as the common combination of bendamustine with Rituxan (rituximab).

Those comparisons are important, according to Jennifer Woyach of the Ohio State University Comprehensive Cancer Center, because Imbruvica's OK in previously untreated CLL was based on its benefit over another chemotherapy called chlorambucil.

FCR chemotherapy, which consists of fludarabine, cyclophosphamide and Rituxan, has been considered the most efficacious treatment for younger CLL patients, while Rituxan plus bendamustine is widely used for older but still fit individuals, according to Leerink analyst Geoffrey Porges.

"The strongly positive results for these trials mean that in the future use of Imbruvica is going to increase significantly in several segments where the drug is still rarely used; these new segments include the non-elderly population and in patients previously considered candidates for aggressive chemoimmunotherapy," Porges wrote in a Dec. 6 note to investors.

Imbruvica results presented at ASH Study Comparison Result ECOG-ACRIN Imbruvica + Rituxan versus FCR in untreated CLL pts aged 70 or younger PFS HR: 0.35; OS HR: 0.17 Alliance Imbruvica +/- Rituxan versus Rituxan + bendamustine in untreated, older CLL pts. PFS HR: 0.39 (mono); PFS HR: 0.38 (combo) iLLUMINATE Imbruvica + Gazyva versus Gazyva + chlorambucil in untreated CLL/SLL pts. PFS HR: 0.23 *FCR=fludarabine, cyclophosphamide and Rituxan; HR=Hazard ratio SOURCE: Companies, NEJM, Lancet Oncology

Questions still remain for physicians, though. Doctors used to FCR may want to see longer survival outcomes with Imbruvica plus Rituxan, Porges noted, and in the Alliance study overall survival curves between the three arms essentially overlapped.

Additionally, Imbruvica would likely need to be given for longer than bendamustine plus Rituxan in untreated older CLL patients.

"The significantly lower rates of undetectable minimal residual disease with the ibrutinib-containing regimens than with bendamustine plus rituximab suggest that treatment with single-agent ibrutinib must be continued indefinitely," researchers from the Alliance study wrote in the New England Journal of Medicine.

AbbVie and J&J are partnered on Imbruvica, sharing responsibility for commercialization in the U.S. while J&J takes lead outside the U.S.

The companies plan to file a supplemental New Drug Application on the ECOG-ACRIN data which, if approved, would allow them to promote the fresh data to physicians.

"Having it in the prescribing information will allow us as a company to go out and educate physicians about how to use this drug," said Mark Wildgust, a vice president of global medical affairs in oncology at J&J's Janssen unit, in an interview with BioPharma Dive.

Commercially, Imbruvica has quickly become a major revenue driver for AbbVie and J&J. In the first nine months of 2018, AbbVie recorded $2.5 billion in sales for the drug.

The ECOG-ACRIN data could drive those numbers higher, but the drug still has a long way to go to hit AbbVie's long-term guidance of $11.5 billion in U.S. sales by 2025 — a target Porges called "aggressive."

Success with Imbruvica is particularly important for AbbVie, which relies heavily on its inflammatory disease drug Humira (adalimumab) for most of its revenue. With biosimilar copies set to launch in the U.S. in 2023, investors are watching closely to see what AbbVie will count on to ease that blow.