Catch­ing up with J&J and Ab­b­Vie on the BTK in­hibitor front, As­traZeneca says Calquence has hit a home run in a Phase III tri­al for first-line chron­ic lym­pho­cyt­ic leukemia.

At an in­ter­im analy­sis, re­searchers say the drug, when com­bined with Roche’s Gazy­va (obin­u­tuzum­ab), has al­ready demon­strat­ed a pro­gres­sion-free sur­vival ben­e­fit over the chemo-based reg­i­men fea­tur­ing chlo­ram­bu­cil and obin­u­tuzum­ab. The pri­ma­ry end­point win was both sta­tis­ti­cal­ly sig­nif­i­cant and clin­i­cal­ly mean­ing­ful, the com­pa­ny says, with­out dis­clos­ing any num­bers.

José Basel­ga As­traZeneca

A third group, which re­ceived Calquence monother­a­py, al­so did bet­ter in PFS than the stan­dard-of-care — a sec­ondary end­point. There was, how­ev­er, no word on oth­er out­come mea­sures such as ob­jec­tive re­sponse rate, time to next treat­ment and over­all sur­vival.

José Basel­ga, who has laid out his am­bi­tion for the on­col­o­gy R&D group that he now leads in a se­ries of re­cent in­ter­views, said the re­sults will ce­ment reg­u­la­to­ry sub­mis­sions lat­er this year.

The dossier will al­so in­clude re­sults from a pre­vi­ous Phase III on pa­tients with re­lapsed or re­frac­to­ry chron­ic lym­pho­cyt­ic leukemia.

Im­bru­vi­ca — the block­buster de­vel­oped by J&J and Ab­b­Vie — in com­bi­na­tion with Gazy­va be­came the first non-chemother­a­py, an­ti-CD20 reg­i­men to be sanc­tioned for treat­ment-naïve CLL this Jan­u­ary, mark­ing the 10th ap­proval since its 2013 launch. The FDA has al­so OK’d its use in this set­ting on its own.

In 2018 Im­bru­vi­ca racked up $2.6 bil­lion in sales, dwarf­ing Calquence — ap­proved for man­tle cell lym­phoma late 2017 — which gen­er­at­ed $62 mil­lion. And Chi­na’s BeiGene is com­ing up from be­hind with its own ‘break­through’ can­di­date.

Im­age: Shut­ter­stock

Women expel on average about 2 to 3 tablespoons of blood during their time of the month. But with uterine fibroids, heavy bleeding is typical — a third of a cup or more. Drugmakers have been working on oral therapies to try and stem the flow, and as expected, AbbVie and their partners at Neurocrine Biosciences are the first to make it across the finish line.

Known chemically as elagolix, the drug is already approved as a treatment for endometriosis under the brand name Orilissa. It targets the GnRH receptor to decrease the production of estrogen and progesterone.

Another day, another win for Enhertu.

The antibody-drug conjugate AstraZeneca promised up-to $7 billion to partner on has had a quite a few months, beginning with splashy results in a Phase II breast cancer trial, a rapid approval and, earlier this month, breakthrough designations in both non-small cell lung cancer and gastric cancer.

Now, at ASCO, the British pharma and their Japanese partner, Daiichi Sankyo, have shown off the data that led to the gastric cancer designation, which they’ll take back to the FDA. In a pivotal, 187-person Phase II trial, Enhertu shrunk tumors in 42.9% of third-line patients with HER2-positive stomach cancer, compared with 12.5% in a control arm where doctors prescribed their choice of therapy. Progression-free survival was 5.4 months for Enhertu compared to 3.5 months for the control.

Back in 2016, when then-Shire CEO Flemming Ørnskov picked up a promising clinical-stage IBD drug from Pfizer, the Boston-based biotech dubbed it SHP647 and moved it into the gem section of the pipeline, with rosy expectations of registration-worthy Phase III data ahead.

This was a drug that the EC wanted Takeda to commit to selling off before it gave their blessing to its acquisition of Shire, to settle some deep-seated concerns revolving around the potential market overlap with their blockbuster rival Entyvio. And Takeda, which took on a heavy debt load to buy Shire, clearly wanted the cash to pay down debt.