J&J boasts im­proved car­dio safe­ty with SGLT2 fran­chise drug In­vokana

David Matthews, Steer­ing Com­mit­tee Co-Chair

J&J scored vi­tal­ly im­por­tant car­dio safe­ty da­ta for its SGLT2 di­a­betes drug In­vokana in a large Phase III out­comes study, which it hap­pi­ly shared with re­searchers at the an­nu­al Amer­i­can Di­a­betes As­so­ci­a­tion con­fer­ence in San Diego on Mon­day af­ter­noon.

The phar­ma gi­ant $JNJ spelled out a slate of pos­i­tive risk re­duc­tions on three key mea­sures, with a 14% re­duc­tion in risk for a com­pos­ite score on CV mor­tal­i­ty as well as non­fa­tal my­ocar­dial in­farc­tion and stroke, with each mea­sure con­tribut­ing to the pos­i­tive score.

In­ves­ti­ga­tors and pay­ers can now pour over the re­sults and start do­ing their com­par­isons with Jar­diance, the ri­val SGLT2 drug from Eli Lil­ly $LLY and Boehringer In­gel­heim which orig­i­nal­ly got this ball rolling two years ago. The big ques­tion now is whether this is a class ef­fect that will even­tu­al­ly ben­e­fit all play­ers, or pro­vide enough da­ta to start to sin­gle out one or two as bet­ter than the rest.

Class ef­fect may be the fa­vorite to­day, as J&J’s com­pos­ite 14% re­duc­tion in risk matched Lil­ly’s over­all num­ber per­fect­ly. Spe­cial­ists, though, will note that not all the end­points matched up, mak­ing cross tri­al com­par­isons tricky.

On the oth­er hand Jar­diance was more ef­fec­tive in cut­ting the risk of death (-38%) com­pared to a much more mod­est 13% re­duc­tion for In­vokana, which achieved more bal­anced ef­fects spread among end­points. And In­vokana was linked to a sig­nif­i­cant­ly high­er risk of am­pu­ta­tions, a safe­ty con­cern that has al­ready trig­gered a black box warn­ing.

Ad­di­tion­al analy­sis al­so demon­strat­ed that In­vokana (canagliflozin) low­ered the risk of HHF by 33% (HR: 0.67; 95% CI: 0.52 to 0.87) and pro­vid­ed sus­tained pos­i­tive ef­fects on glycemic and blood pres­sure con­trol, as well as weight re­duc­tion, with “wide-rang­ing dura­bil­i­ty,” J&J said in its state­ment. In ad­di­tion, the phar­ma gi­ant not­ed, their drug de­layed pro­gres­sion of al­bu­min­uria and re­duc­ing the risk of clin­i­cal­ly im­por­tant re­nal com­pos­ite out­comes (such as re­nal death, re­nal re­place­ment ther­a­py, and 40% re­duc­tion of eGFR) by 40%.

Mer­ck $MRK and Pfiz­er $PFE on­ly re­cent­ly out­lined their pos­i­tive Phase III da­ta for er­tugliflozin, look­ing for an ap­proval that will put them up against In­vokana, Jar­diance as well as As­traZeneca’s Farx­i­ga. Their car­dio out­comes da­ta, though, isn’t ex­pect­ed un­til 2019, giv­ing the lead­ers plen­ty of time to get fur­ther es­tab­lished first.

“Pa­tients with di­a­betes are two to four times more like­ly to suf­fer from as­so­ci­at­ed co­mor­bidi­ties, such as heart fail­ure and kid­ney dis­ease, and the CAN­VAS re­sults demon­strate the po­ten­tial of canagliflozin in re­duc­ing the risk for such con­di­tions in high-risk type 2 di­a­betes pa­tients,” said David Matthews, the tri­al’s steer­ing com­mit­tee co-chair and a pro­fes­sor of di­a­bet­ic med­i­cine at the Uni­ver­si­ty of Ox­ford. “These da­ta are promis­ing as they sug­gest canagliflozin may of­fer po­ten­tial ben­e­fits for pa­tients with type 2 di­a­betes, who are al­so fac­ing com­pli­ca­tions from, or are at risk for, hos­pi­tal­iza­tion for heart fail­ure or kid­ney dis­ease.”


Im­age: Shut­ter­stock

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Paul Hudson, Sanofi CEO (Getty Images)

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The Avance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

David Chang, Allogene CEO (Jeff Rumans)

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Pablo Legorreta, founder and CEO of Royalty Pharma AG, speaks at the annual Milken Institute Global Conference in Beverly Hills, California (Patrick T. Fallon/Bloomberg via Getty Images)

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