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

Earlier this year, an executive from Juvenescence-backed AgeX predicted the field of longevity will eventually “dwarf the dotcom boom.” Greg Bailey, the UK-based anti-aging biotech’s CEO, certainly hopes so.

On Monday, Juvenescence completed its $100 million series B round of financing. The company is backed by British billionaire Jim Mellon — who wrote his 400-page guide to investing in the field of longevity shortly after launching the company in 2017.  Bailey, who served as a board director for seven years at Medivation before Pfizer swallowed the biotech for $14 billion, is joined by Declan Doogan, an industry veteran with stints at Pfizer and Amarin.

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

After a “hot” period of rapid growth between 2009 and 2012, and a relatively “cooler” period of slower growth from 2013 to 2015, China has once again become a top-of-mind priority for the CEOs of most large, multinational pharmaceutical companies.

At the International Pharma Forum, hosted in March in Beijing by the R&D Based Pharmaceutical Association Committee (RDPAC) and the Pharmaceutical Research and Manufacturers of America (PhRMA), no fewer than seven CEOs of major multinational pharmaceutical firms participated, including GSK, Eli Lilly, LEO Pharma, Merck KGaA, Pfizer, Sanofi and UCB. A few days earlier, the CEOs of several other large multinationals attended the China Development Forum, an annual business forum hosted by the research arm of China’s State Council. It’s hard to imagine any other country, except the US, having such drawing power at CEO level.