BeiGene's Brukin­sa wins CLL ap­proval af­ter top­ping Im­bru­vi­ca in head-to-head tri­al

The FDA green­lit BeiGene’s Brukin­sa for use in chron­ic lym­pho­cyt­ic leukemia, an ap­proval that should sub­stan­tial­ly ex­pand the mar­ket for the drug in the US af­ter it topped the cur­rent lead­ing ther­a­py in a tri­al.

The ap­proval, which is for re­lapsed/re­frac­to­ry and first-line treat­ment for adults with CLL as well as small lym­pho­cyt­ic lym­phoma, is the drug’s fourth US clear­ance. It comes af­ter BeiGene showed the twice-dai­ly oral drug beat the stan­dard of care, Ab­b­Vie and John­son & John­son’s Im­bru­vi­ca, in a head-to-head test.

“This is the most im­por­tant for BeiGene,” Mehrdad Mobash­er, who re­placed Jane Huang last year as the biotech’s CMO for hema­tol­ogy, told End­points News be­fore the FDA de­ci­sion. “CLL is the most com­mon leukemia in adults.”

BeiGene has been count­ing on the rul­ing as a cru­cial step to sig­nif­i­cant­ly ex­pand­ing its US sales, and to help the com­pa­ny re­al­ize its am­bi­tions of ex­pand­ing fur­ther in can­cer as well as oth­er ar­eas. And while the da­ta are strong, the com­pa­ny will be up against an en­trenched com­peti­tor.

Through the first three quar­ters of 2022, BeiGene racked up $388.5 mil­lion in glob­al rev­enue for Brukin­sa, ac­cord­ing to fi­nan­cial re­ports. Im­bru­vi­ca’s glob­al net rev­enues were $3.45 bil­lion in the same pe­ri­od and Calquence brought in $1.46 bil­lion in world­wide rev­enue in that nine-month stretch.

Im­bru­vi­ca has been on the mar­ket for close to nine years and gar­nered eye-pop­ping head­lines for Ab­b­Vie’s $21 bil­lion pur­chase of Phar­ma­cyclics in 2015. As­traZeneca fol­lowed suit half a year lat­er with a multi­bil­lion dol­lar pur­chase of the sec­ond-gen BTK in­hibitor, Ac­er­ta’s Calquence, which was brought through the clin­ic by many of the lead­ers who led Im­bru­vi­ca’s ear­ly in­ves­ti­ga­tion­al plans.

Head-to-head tri­al

Tri­al in­ves­ti­ga­tor Jen­nifer Brown said the safe­ty of Brukin­sa was al­so bet­ter than Im­bru­vi­ca, in­clud­ing a low­er rate of car­diac dis­or­ders. Brown, who is al­so the di­rec­tor of the Dana-Far­ber Cen­ter for Chron­ic Lym­pho­cyt­ic Leukemia, told re­porters at last month’s Amer­i­can So­ci­ety of Hema­tol­ogy meet­ing that she doesn’t think there’s a group of CLL pa­tients for whom Im­bru­vi­ca would re­main the stan­dard.

In the ALPINE study of about 650 pa­tients, the rate of pro­gres­sion-free sur­vival was 79.5% for pa­tients on BeiGene’s drug and 67.3% for those on Im­bru­vi­ca at 24 months. In the re­lapsed/re­frac­to­ry set­ting, BeiGene said 80.4% of pa­tients on Brukin­sa re­spond­ed, ver­sus 72.9% on Im­bru­vi­ca, with a p-val­ue of 0.0264.

In a dif­fer­ent Phase III tri­al, dubbed SE­QUOIA, BeiGene had shown that Brukin­sa led to a bet­ter pro­gres­sion-free sur­vival than the com­bo of the can­cer drugs ben­damus­tine and Rit­ux­an.

Brukin­sa land­ed its first FDA win in No­vem­ber 2019 for pa­tients with the rare, ag­gres­sive blood can­cer known as man­tle cell lym­phoma. An­oth­er nod came in Au­gust 2021 for a rare form of lym­phoma known as Walden­ström’s macroglob­u­line­mia, de­spite Brukin­sa fail­ing in a head-to-head against Im­bru­vi­ca.

A month lat­er, in Sep­tem­ber 2021, FDA ex­pand­ed the la­bel to in­clude adult pa­tients with re­lapsed or re­frac­to­ry mar­gin­al zone lym­phoma (MZL) who have re­ceived at least one an­ti-CD20-based reg­i­men.

Mehrdad Mobash­er

It’s good for an el­der­ly pop­u­la­tion to have “more med­ica­tions and more tol­er­a­ble treat­ments,” he added.

The Na­tion­al Com­pre­hen­sive Can­cer Net­work al­so showed its pref­er­ence for Brukin­sa in re­cent months, ahead of the ex­pand­ed la­bel, up­dat­ing its guide­lines to rec­om­mend physi­cians choose the drug be­fore Im­bru­vi­ca for treat­ing CLL.

The Eu­ro­pean Com­mis­sion ap­proved the drug for CLL in No­vem­ber. Across the board, Brukin­sa is ap­proved in more than 60 mar­kets and has been stud­ied in more than 30 clin­i­cal tri­als, BeiGene said.

Com­pa­ny am­bi­tions

“Most of our time is spent look­ing at on­col­o­gy be­cause this is our strength,” Beigene CEO John Oyler told End­points at the JP Mor­gan health­care con­fer­ence in San Fran­cis­co ear­li­er this month. “We’re start­ing to look in oth­er ar­eas that are tan­gen­tial to this and oth­er things we could do to lever­age some of the in­fra­struc­ture we have.”

About 20,000 new cas­es of the spe­cif­ic lym­phoma were ex­pect­ed in 2022, ac­cord­ing to Dana-Far­ber. CLL is when can­cer cells pop­u­late in the bone mar­row and blood­stream, where­as with small lym­pho­cyt­ic the can­cer is main­ly in the lymph nodes.

Brukin­sa and Im­bru­vi­ca are both co­va­lent Bru­ton’s ty­ro­sine ki­nase in­hibitors, which aim to block a pro­tein that helps send sig­nals that dri­ve the growth of leukemia and lym­phoma cells. If the pro­tein sig­nal is blocked in B cells, then the can­cer cells should be wiped away, re­searchers be­lieve. But Im­bru­vi­ca has been shown to have off-tar­get ef­fects, mean­ing it im­pairs not just the BTK pro­tein.

The next gen­er­a­tion of BTK in­hibitors, ones that don’t co­va­lent­ly bond, could come to mar­ket soon. Ear­ly this year, the FDA is set to de­cide whether to ap­prove Eli Lil­ly’s pir­to­bru­ti­nib in BTK pre-treat­ed man­tle cell lym­phoma pa­tients.

Paul Schloess­er con­tributed re­port­ing. 

Ed­i­tor’s note: CLL is an ab­bre­vi­a­tion for chron­ic lym­pho­cyt­ic leukemia, not lym­phoma.

Sen. Ron Wyden (D-OR) (Francis Chung/E&E News/Politico via AP Images)

In­fla­tion re­bates in­com­ing: Wyden calls on CMS to move quick­ly as No­var­tis CEO pledges re­ver­sal

Senate Finance Chair Ron Wyden (D-OR) this week sent a letter to the head of the Centers for Medicare & Medicaid Services seeking an update on how and when new inflation-linked rebates will take effect for drugs that see major price spikes.

The newly signed Inflation Reduction Act requires manufacturers to pay a rebate to Medicare when they increase drug prices faster than the rate of inflation.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Teresa Graham, incoming Roche Pharmaceuticals CEO

In­com­ing Roche CEO builds out his top team, tap­ping Genen­tech vet to lead phar­ma di­vi­sion

Roche announced another leadership shuffle Thursday morning – the head of global product strategy, Teresa Graham, will take over as CEO of Roche Pharmaceuticals in March while the company’s corporate executive committee will make a spot for Levi Garraway, CMO and executive VP of global product development.

Thomas Schinecker will take over the top spot as Roche group CEO in March, leaving his spot as head of diagnostics.

Trodelvy notch­es a win in most com­mon form of breast can­cer

Following a promise last year to go “big and fast in breast cancer,” Gilead has secured a win for Trodelvy in the most common form.

The drug was approved to treat HR-positive, HER2-negative breast cancer patients who’ve already received endocrine-based therapy and at least two other systemic therapies for metastatic cancer, Gilead announced on Friday.

Trodelvy won its first indication in metastatic triple-negative breast cancer back in 2020, and has since added urothelial cancer to the list. HR-positive HER2-negative breast cancer accounts for roughly 70% of new breast cancer cases worldwide per year, according to senior VP of oncology clinical development Bill Grossman, and many patients develop resistance to endocrine-based therapies or worsen on chemotherapy.

FDA ap­proves GSK's ane­mia drug with safe­ty warn­ing — af­ter bat­ting back sim­i­lar drugs

GSK has secured the first of four US approvals it’s hoping for this year, as the FDA greenlit daprodustat as a treatment for anemia due to chronic kidney disease.

But the FDA limited the use of the drug, to be marketed as Jesduvroq, to patients who have been receiving dialysis for at least four months and stopped short of approving it for patients not dependent on dialysis — in line with the recommendations of the advisory committee it consulted.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Te­va drops out of in­dus­try trade group PhRMA

Following in AbbVie’s footsteps, Teva confirmed on Friday that it’s dropping out of the industry trade group Pharmaceutical Research and Manufacturers of America (PhRMA).

Teva didn’t give a reason for its decision to leave, saying only in a statement to Endpoints News that it annually reviews “effectiveness and value of engagements, consultants and memberships to ensure our investments are properly seated.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.

Sanofi CFO Jean-Baptiste de Chatillon (L) and CEO Paul Hudson (Romuald Meigneux/Sipa via AP Images)

Sanofi sees downtick in flu sales as it preps for launch of RSV an­ti­body

Sanofi expects its RSV antibody jointly developed with AstraZeneca will be available next season, executive VP of vaccines Thomas Triomphe announced on the company’s quarterly call.

Beyfortus, also known as nirsevimab, was approved in the EU back in November and is currently under FDA review with an expected decision coming in the third quarter of this year. The news comes as the FDA plans to hold advisory committee meetings over the next couple months to review RSV vaccines from Pfizer and GSK.

Christophe Weber, Takeda CEO (Photographer: Shoko Takayasu/Bloomberg via Getty Images)

Take­da fo­cus­es on ‘di­verse’ pipeline prospects on heels of two ac­qui­si­tions

After a whopping $4 billion asset buy from Nimbus Therapeutics, along with a $400 million deal with Hutchmed for a colorectal cancer drug, Takeda executives touted pipeline optimism on its latest earnings call this week.

That’s because the TYK2 inhibitor for psoriasis Takeda is getting from Nimbus, along with the Hutchmed fruquintinib commercialization outside of China, are just two of what it reports are 10 late-stage development programs of promising candidates.

Regeneron CSO George Yancopoulos (L) and CEO Len Schleifer at a groundbreaking for its new Tarrytown, NY facility, June 2022 (Lev Radin/Pacific Press/LightRocket via Getty Images)

In show­down with Roche, Re­gen­eron gears up for po­ten­tial Eylea ex­pan­sion amid Covid de­cline

Regeneron faced a substantial slump in overall revenue last year, but the focus still remains on some of its biggest blockbusters.

The pharma with several high-profile partnerships — Sanofi and Bayer among them — said Friday that Q4 revenue was down 31% for the quarter, and down 24% for the entire year. However, that won’t stop blockbuster expansion plans.

One of those is Eylea, the Bayer-partnered eye disease drug that has been in major competition with Roche’s Vabysmo. While Eylea is currently only approved in a 2 mg dose, the company recently filed for approval to give a 8 mg dose, in hopes of making a longer-lasting treatment.

BeiGene's new website helps direct cancer patients and caregivers to a wide variety of sources for help.

BeiGene re­veals men­tal health and can­cer care gap in study, de­buts dig­i­tal re­sources

One-fourth of cancer patients are living with depression — and another 20% suffer from anxiety. That’s according to new study results from BeiGene, conducted by Cancer Support Community (CSC), about the mental and emotional health of cancer patients.

While the fact that people with cancer are also dealing with depression or anxiety may not be surprising, what is — and was to BeiGene — is that a majority of them aren’t getting support. 60% of respondents said they were not referred to a mental health professional, and even more concerning, two in five who specifically asked for mental health help did not get it. CSC, a nonprofit mental health in cancer advocacy group, surveyed more than 600 US cancer patients.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 158,500+ biopharma pros reading Endpoints daily — and it's free.