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

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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FDA ap­proves an­oth­er in­di­ca­tion for Keytru­da, this time in the ad­ju­vant NSCLC set­ting

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.

Ying Huang, Legend CEO

J&J, Leg­end say Carvyk­ti beat stan­dard ther­a­py in ear­li­er-line blood can­cer

J&J and Legend Biotech’s next step in turning their CAR-T therapy Carvykti into a potential megablockbuster has succeeded, the companies said Friday.

Carvykti achieved the primary endpoint — progression-free survival — in an open-label Phase III study testing the treatment in second- to fourth-line multiple myeloma patients. The CARTITUDE-4 trial, for which there aren’t any hard data yet, represents the biggest development for Carvykti’s ability to compete with Bristol Myers Squibb’s Abecma since its approval last February.

Dutch biotech starts liq­ui­da­tion af­ter end­ing PhI­II in GVHD

A 13-year-old Dutch biotech is going through a liquidation process after an unexpected end to its Phase III trial testing whether its combination of two monoclonal antibodies was superior to Incyte’s Jakafi.

Xenikos had hoped to prove its investigational therapy, named T-Guard, was better than Jakafi at garnering a complete response in patients experiencing life-threatening complications in which new cells from a hematopoietic stem cell transplant begin to fight the body. Jakafi was approved for the indication, steroid-refractory acute graft-versus-host disease, in May 2019.

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Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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