J&J, Gen­mab strength­en case for Darza­lex in front­line mul­ti­ple myelo­ma with fresh slate of PhI­II da­ta

J&J and Gen­mab of­fered a snap­shot of the Phase III da­ta that got Darza­lex its pri­or­i­ty re­view for front­line use late last week, high­light­ing how adding the block­buster mul­ti­ple myelo­ma drug to a chemother­a­py reg­i­men im­proved the com­plete re­sponse rate. The part­ners are now ready to ex­pound on the full ex­tent of that ben­e­fit with some num­bers on pro­gres­sion-free sur­vival.

The re­sults of the CAS­SIOPEIA study were pub­lished in The Lancet amid a flood of da­ta from AS­CO, where Sanofi al­so de­lin­eat­ed a case for its ri­val an­ti-CD38 ther­a­py, isat­ux­imab, by com­par­ing a com­bo with po­ma­lido­mide and dex­am­etha­sone against the chemo/cor­ti­cos­teroid alone.

Philippe More­au In­ter­na­tion­al Myelo­ma So­ci­ety

“There is a need for new treat­ment op­tions for new­ly di­ag­nosed pa­tients, po­ten­tial­ly in­clud­ing this com­bi­na­tion ther­a­py with dara­tu­mum­ab,” said Philippe More­au, pri­ma­ry in­ves­ti­ga­tor and head of the hema­tol­ogy de­part­ment at the Uni­ver­si­ty Hos­pi­tal of Nantes, France, in a state­ment. “This study adds to the grow­ing body of ev­i­dence for dara­tu­mum­ab in the front­line set­ting.”

As pre­vi­ous­ly re­port­ed, the group re­ceiv­ing Darza­lex plus the stan­dard of care VTD — Vel­cade(borte­zomib), thalido­mide and dex­am­etha­sone — notched a strin­gent com­plete re­sponse rate of 29% 100 days af­ter their au­tol­o­gous stem cell trans­plant, ver­sus 20% in the VTD arm (odds Ra­tio = 1.60; p<0.0010).

Fur­ther­more, DARZA­LEX-VTD in­creased the rate of very good par­tial re­sponse or bet­ter (83% ver­sus 78%, p<0.0239) and com­plete re­sponse or bet­ter (39% ver­sus 26%, p<0.0001).

Then there’s the sec­ond, on­go­ing part of the 1085-pa­tient study mea­sur­ing PFS in the pa­tients who show at least a par­tial re­sponse, the me­di­an for which has not been reached in ei­ther arm. But the 18-month PFS rate for the com­bo group was 93% — a sig­nif­i­cant im­prove­ment from VTD’s 85% ac­cord­ing to J&J. Haz­ard ra­tio came in at 0.47 with p<0.0001.

John Reed Sanofi

As J&J and Gen­mab await a de­ci­sion on their sBLA in Sep­tem­ber, Sanofi has a foot in US and EU reg­u­la­tors’ door for isat­ux­imab’s first ap­proval. Their drug scored a clear win on pro­gres­sion-free sur­vival for re­lapsed or re­frac­to­ry pa­tients, with 11.53 months for the com­bi­na­tion of isat­ux­imab and pom-dex com­pared to 6.47 months for pom-dex alone. The p-val­ue was 0.001.

The com­bi­na­tion al­so scored a 60% over­all re­sponse rate, com­pared to 35% for pom-dex alone — al­so sta­tis­ti­cal­ly sig­nif­i­cant.

Sanofi R&D chief John Reed con­tends that their drug, a late-stage fa­vorite in his plan to re­vamp the phar­ma gi­ant’s on­col­o­gy group, “has fea­tures that dif­fer­en­ti­ate it from dara­tu­mum­ab.” For in­stance, it di­rect­ly in­duces apop­to­sis in myelo­ma cells, hit­ting the tu­mor mi­croen­vi­ron­ment.

Ex­pect ag­gres­sive moves in­to front­line and sec­ond-line ter­ri­to­ry to fol­low, Reed told End­points News at AS­CO as he en­vi­sions a $3 bil­lion mar­ket op­por­tu­ni­ty. But J&J and an al­most pub­lic Gen­mab are com­ing to the de­fense pre­pared.


Im­age: Shut­ter­stock

Levi Garraway. Broad Institute via Youtube

Roche raids Eli Lil­ly for its next chief med­ical of­fi­cer as San­dra Horn­ing plans to step down

We found out Monday morning where Levi Garraway was headed after he left Eli Lilly as head of oncology R&D a few days ago. Roche named Garraway as their new chief medical officer, replacing Sandra Horning, who they say is retiring from the company.

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Novartis CEO Vas Narasimhan [via Bloomberg/Getty]

I’m not per­fect: No­var­tis chief Vas Narasimhan al­most apol­o­gizes in the wake of a new cri­sis

Vas Narasimhan has warily stepped up with what might pass as something close to a borderline apology for the latest scandal to engulf Novartis.

But he couldn’t quite get there.

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Af­ter a posse of Wall Street an­a­lysts pre­dict a like­ly new win for Sarep­ta, we're down to the wire on a crit­i­cal FDA de­ci­sion

As Bloomberg notes, most of the Wall Street analysts that cover Sarepta $SRPT are an upbeat bunch, ready to cheer on the team when it comes to their Duchenne MD drugs, or offer explanations when an odd setback occurs — as happened recently with a safety signal that was ‘erroneously’ reported last week.

Ritu Baral Cowen
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Saqib Islam. CheckRare via YouTube

Spring­Works seeks $115M to push Pfiz­er drugs across fin­ish line while Sat­suma sells mi­graine play in $86M IPO

SpringWorks and Satsuma — both biotech spinouts that have closed B rounds in April — are loading up with IPO cash to boost their respective late-stage plans.
SpringWorks

Bain-backed SpringWorks is the better-known company of the two, and it’s gunning for a larger windfall of $115 million to add to $228 million from previous financings. In the process, the Stamford, CT-based team is also drawing the curtains on the partnerships it has in mind for the pair of assets it had initially licensed from Pfizer.

Mi­nor­i­ty racial groups con­tin­ue to be dis­mal­ly rep­re­sent­ed in can­cer tri­als — study

Data reveal that different racial and ethnic groups — by nature and/or nurture — can respond differently in terms of pharmacokinetics, efficacy, or safety to therapeutics, but this disparity is not necessarily accounted for in clinical trials. A fresh analysis of the last decade of US cancer drug approvals suggests the trend continues, cementing previous research that suggests oncology trials are woefully under-representative of the racial makeup of the real world.

Van­da shares slide af­ter FDA spurns their big end­point and re­jects a pitch on jet lag re­lief

Back in the spring of last year, Vanda Pharmaceuticals $VNDA served up a hot stew of mixed data for a slate of endpoints related to what they called clear evidence that their melatonin sleep drug Hetlioz (tasimelteon) could help millions of travelers suffering from jet lag.

Never mind that they couldn’t get a planned 90 people in the study, settling for 25 instead; Vanda CEO Mihael H. Polymeropoulos said they were building on a body of data to prove it would help jet-lagged patients looking for added sleep benefits. And that, they added, would be worth a major upgrade from the agency as they sought to tackle a big market.

Jim Mellon [via YouTube]

Health­i­er, longer lifes­pans will be a re­al­i­ty soon­er than you think, Ju­ve­nes­cence promis­es as it clos­es $100M round

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 $PFE and Amarin $AMRN.

AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

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.