As­traZeneca's prized Imfinzi/treme­li­mum­ab com­bo fails again — this time in head and neck can­cer

As­traZeneca’s big bet on a com­bi­na­tion of its check­point in­hibitor Imfinzi and in-house CT­LA-4 drug has proved ex­ceed­ing­ly cost­ly. The British drug­mak­er con­ced­ed on Fri­day that the com­bi­na­tion had failed to im­prove over­all sur­vival in cer­tain pa­tients with head and neck can­cer, in ad­di­tion to the big flop in the keen­ly-watched MYS­TIC lung can­cer tri­al re­port­ed last month.

The com­bi­na­tion — once tout­ed as the cor­ner­stone of As­traZeneca’s $AZN check­point de­vel­op­ment strat­e­gy — did not meet the main goal of help­ing pa­tients with re­cur­rent or metasta­t­ic head and neck squa­mous cell car­ci­no­ma (HN­SCC) whose dis­ease had spread de­spite plat­inum-based chemother­a­py live longer, when com­pared to stan­dard chemother­a­py.

The late-stage EA­GLE tri­al was test­ing Imfinzi monother­a­py, as well as the com­bi­na­tion of Imfinzi and treme­li­mum­ab, ver­sus stan­dard-of-care chemother­a­py. Nei­ther the monother­a­py nor the com­bi­na­tion met the main goals of im­prov­ing over­all sur­vival, the com­pa­ny said, with­out of­fer­ing fur­ther de­tail on the re­sults, or pro­vid­ing any da­ta on sec­ondary end­points such as pro­gres­sion-free sur­vival.

But the com­pa­ny was in­sis­tent it may still find a way for­ward for the com­bi­na­tion.

Sean Bo­hen

“While these re­sults are dis­ap­point­ing, we re­main com­mit­ted to eval­u­at­ing the po­ten­tial of Imfinzi and oth­er in­no­v­a­tive med­i­cines for pa­tients with head and neck can­cer. We look for­ward to see­ing the re­sults of the Phase III KESTREL tri­al of Imfinzi and treme­li­mum­ab in pa­tients who have not re­ceived pri­or chemother­a­py for re­cur­rent or metasta­t­ic head and neck squa­mous cell car­ci­no­ma in the first half of 2019,” chief med­ical of­fi­cer Sean Bo­hen said in a state­ment.

While As­traZeneca’s pipeline has of­ten come up short, there have been a string of ma­jor suc­cess­es in on­col­o­gy for the com­pa­ny that have in­spired a re­turn to sales growth af­ter years of shrink­ing rev­enue. This Imfinzi/treme­li­mum­ab com­bi­na­tion, how­ev­er, was con­sid­ered crit­i­cal to putting the brakes on the blitz­ing gains Mer­ck $MRK and Bris­tol-My­ers Squibb $BMY have made af­ter es­tab­lish­ing their lead in the lu­cra­tive front­line can­cer field. The com­pa­ny has al­so re­cent­ly re­port­ed a string of set­backs for its res­pi­ra­to­ry drugs, cap­ping a year of hits-and-miss­es for CEO Pas­cal So­ri­ot, who as ru­mor has it, may be on his way out.


Im­age: Pas­cal So­ri­ot. AP IM­AGES

Brian Kaspar. AveXis via Twitter

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I reached out to Brian Kaspar after Novartis put out word that he and his brother Allen had been axed in mid-May, two months after the company became aware of the allegations related to manipulated data. His response came back through his attorneys.

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The treatments, in addition to Jardiance from Eli Lilly $LLY, belong to a class of diabetes drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors, which work by curbing the absorption of glucose via the kidneys so that surplus glucose is excreted through urination.

Novartis CEO Vas Narasimhan [via Bloomberg/Getty]

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In a statement that arrived after the bell on Monday, Sarepta explained the CRL, saying:

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Levi Garraway. Broad Institute via Youtube

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Ritu Baral Cowen
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The drug, lefamulin, has been developed as an intravenous and oral formulation and been tested in two late-stage clinical trials. The semi-synthetic compound, whose dosing can be switched between the two formulations, is engineered to inhibit the synthesis of bacterial protein by binding to a part of the bacterial ribosome.

Saqib Islam. CheckRare via YouTube

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SpringWorks

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