AbbVie, J&J get win in UK for Imbruvica combo as BeiGene, AZ surge with single agents

Dazzling trial data, followed by FDA approval three months ago in the most common form of leukemia have set BeiGene’s Brukinsa up to become the dominant force in treating blood cancer.

AbbVie and Johnson & Johnson’s Imbruvica may have started to lose popularity in the BTK inhibitor rivalry. But on Friday, the companies got a small victory as England’s National Institute for Health and Care Excellence (NICE) recommended Imbruvica in combination with Roche and AbbVie’s Venclyxta as an option for people with untreated chronic lymphocytic leukemia (CLL).

NICE signed off on the combo because clinical evidence shows it keeps people alive longer and staves off disease progression longer than other approved treatments for CLL, the regulator said, in addition to causing fewer side effects.

Imbruvica was already approved by the National Health Service (NHS) as a solo treatment for CLL or in combination with Roche’s Gazyva or rituximab. Also approved in the U.K. as a solo agent for first-line CLL is AstraZeneca’s Calquence.

The NHS also has sanctioned BCL-2 inhibitor Venclyxta (known as Venclexta in the U.S.) in combination with Gazyva for previously untreated CLL patients. The FDA blessed the combo for CLL in 2019.

CLL is the most common form of leukemia. BeiGene got its U.S. approval for Brukinsa in the indication in January, along with a nod for small lymphocytic lymphoma (SLL).

Brukinsa also holds a victory over Imbruvica in a head-to-head trial on previously treated CLL/SLL patients, as it showed a 35% edge in cutting the risk of cancer progression or death. The victory also gives Brukinsa an edge over Calquence, which was shown in its head-to-head study against Imbruvica to have non-inferior efficacy.

Another key finding from BeiGene’s phase 3 ALPINE trial was that Brukinsa caused lower rates of irregular heartbeats than Imbruvica. All three of the drugs are BTK inhibitors.

Brukinsa has already dug into the sales of Imbruvica. BeiGene reported sales of $565 million for the drug last year after $218 million in 2021, while AbbVie reported 2022 worldwide sales of Imbruvica at $4.6 billion, which was a decline of 15%. Calquence’s sales reached (PDF) $2.1 billion last year, which was a 66% increase from the previous year.