Roche/Ex­elix­is' Cotel­lic fiz­zles in piv­otal melanoma study

To lit­tle sur­prise, Ex­elix­is’ Cotel­lic — known chem­i­cal­ly as co­bime­tinib — in com­bi­na­tion with Roche’s Tecen­triq, has failed a late-stage study as a front­line treat­ment for pa­tients with a form of ad­vanced melanoma.

The Alame­da, Cal­i­for­nia-based com­pa­ny’s $EX­EL ki­nase in­hibitor — out-li­censed to Roche — was ap­proved in 2015 in com­bi­na­tion with the Swiss drug­mak­er’s Zelb­o­raf (ve­mu­rafenib) for pa­tients with BRAF V600E or V600K mu­ta­tion-pos­i­tive un­re­sectable or metasta­t­ic melanoma. Cotel­lic gen­er­at­ed rough­ly $61 mil­lion in glob­al sales last year.

Re­sults of the IM­spire170 study were dis­closed in a fil­ing on Thurs­day. Ex­elix­is said that Genen­tech (Roche), which spon­sored the study, had found that co­bime­tinib + Tecen­triq (ate­zolizum­ab) did not re­duce the risk of dis­ease pro­gres­sion or death com­pared to stan­dard-of-care Keytru­da, Mer­ck’s flag­ship PD-1 im­munother­a­py, in treat­ment-naïve pa­tients with BRAF V600 wild-type ad­vanced melanoma.

Last year, in the Phase III IM­blaze370 study, co­bime­tinib + Roche’s PD-L1 Tecen­triq failed to sig­nif­i­cant­ly help pa­tients with col­orec­tal can­cer live longer.

The like­li­hood of co­bime­tinib en­hanc­ing the im­pact of check­point in­hibitor ther­a­py in this melanoma tu­mor type (and oth­ers) was great­ly di­min­ished fol­low­ing last year’s dis­clo­sure of IM­blaze370 da­ta, Stifel’s Stephen Wil­ley wrote in a note. “We don’t view this news as the­sis-chang­ing (i.e. co­bime­tinib is not part of our, or any­one’s, near- or longer-term EX­EL the­sis) and con­tin­ue to view the dis­place­ment of 1L im­munother­a­py in this set­ting as un­like­ly.”

BMO Cap­i­tal Mar­ket’s George Farmer said the da­ta were in­con­se­quen­tial to his over­all Ex­elix­is in­vest­ment the­sis. “Phase 3 suc­cess (in the IM­spire170 study) would on­ly pro­vide up­side to ex­ist­ing co­bi sales, which was not fac­tored in­to our mod­el.”

An­oth­er co­bime­tinib late-stage tri­al, called IM­spire150 TRIL­O­GY, is ex­pect­ed to read out be­fore the end of this year. The study is eval­u­at­ing a triplet com­bi­na­tion of ve­mu­rafenib/co­bime­tinib/ate­zolizum­ab ver­sus the dou­blet com­bi­na­tion of ve­mu­rafenib/co­bime­tinib in pa­tients with first­line BRAF mu­tant ad­vanced melanoma. “(T)his triplet vs. dou­blet tri­al as more of a ‘check the box’ vs. an ‘ex­pand the mar­ket’ ex­er­cise and, like IM­spire170, don’t view IM­spire150 topline re­sults as a key cat­a­lyst for the stock,” Wil­ley wrote.

“We al­so be­lieve the on­go­ing eval­u­a­tion of oth­er triple-ther­a­py com­bi­na­tions (BRAF/MEK/PD-1) in 1L BRAF-mu­tant melanoma by oth­er, more-en­trenched com­peti­tors would like­ly keep any en­thu­si­asm re­lat­ed to a po­ten­tial TRIL­O­GY win ap­pro­pri­ate­ly mut­ed.”

Ex­elix­is’ for­tunes large­ly rest on the po­ten­tial of its TKI Cabome­tyx (cabozan­ti­nib) in the treat­ment of re­nal cell and he­pa­to­cel­lu­lar car­ci­no­ma. Top-line re­sults from the Check­mate-9ER tri­al, eval­u­at­ing cabozan­ti­nib plus Bris­tol-My­er’s $BMY PD-1 Op­di­vo, ver­sus Pfiz­er’s $PFE suni­tinib, are ex­pect­ed in the first half of 2020.

But com­pe­ti­tion is fierce. Mer­ck’s $MRK Keytru­da has been ap­proved in com­bi­na­tion with Pfiz­er’s TKI In­ly­ta for RCC pa­tients, as has Ger­man Mer­ck’s check­point in­hibitor, Baven­cio, (in com­bi­na­tion with In­ly­ta) for the pa­tient pop­u­la­tion.

So­cial im­age: Shut­ter­stock

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

The End­points 11: They've got mad mon­ey and huge am­bi­tions. It's time to go big or go home

These days, selecting a group of private biotechs for the Endpoints 11 spotlight begins with a sprint to get ahead of IPOs and the M&A teams at Big Pharma. I’ve had a couple of faceplants earlier this year, watching some of the biotechs on my short list choose a quick leap onto Nasdaq or into the arms of a buyer.

Vividion, you would have been a great pick for the Endpoints 11. I’m sorry I missed you.

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Dave Lennon, former president of Novartis Gene Therapies

So what hap­pened with No­var­tis Gene Ther­a­pies? Here's your an­swer

Over the last couple of days it’s become clear that the gene therapy division at Novartis has quietly undergone a major reorganization. We learned on Monday that Dave Lennon, who had pursued a high-profile role as president of the unit with 1,500 people, had left the pharma giant to take over as CEO of a startup.

Like a lot of the majors, Novartis is an open highway for head hunters, or anyone looking to staff a startup. So that was news but not completely unexpected.

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Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

FDA au­tho­rizes Pfiz­er's vac­cine boost­er for se­niors, those at high risk for se­vere Covid-19

The Biden administration’s goal of kicking off its booster shot drive for the entire US population this week is not quite going as planned.

First, Pfizer applied for approval of a supplemental application for the booster shots, but since last Friday’s adcomm reviewing them, the plan has devolved into an EUA, which the FDA issued late Thursday evening.

The population that is now eligible for the booster, six months after receiving the first pair of Pfizer-BioNTech vaccines, also narrowed from what Pfizer applied for (everyone who’s eligible for the initial Pfizer shots) to just those who are 65 or older, or at high-risk of a Covid infection, including health care workers and others with occupational hazards.

Stéphane Bancel, AP Images

Fi­nal analy­sis of US-fund­ed Mod­er­na Covid vac­cine tri­al shows 98% ef­fi­ca­cy against se­vere dis­ease

A final look at the results of the placebo-controlled Moderna trial in the New England Journal of Medicine, published Thursday afternoon, shows how the vaccine continues to prevent Covid-19 and severe cases after more than five months following the second shot.

Of the more than 30,000 enrolled in the trial that ultimately led to the vaccine’s EUA, only two people in the vaccine group got a severe form of the disease, compared to 106 in the placebo group — leading to an efficacy of 98%.

Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

The fire un­der Glax­o­SmithK­line's Em­ma Walm­s­ley grows as an­oth­er well-known ac­tivist in­vestor grabs its pitch­fork — re­port

Bluebell Capital Partners, a proxy brawler fresh off a campaign to oust global food giant Danone’s CEO and most of its board of directors, has bought a stake in UK drugmaker GlaxoSmithKline with its eyes trained directly on Emma Walmsley, the Financial Times reported Wednesday.

The London-based hedge fund joins another notorious activist firm in Paul Singer’s Elliott Management, which earlier this year called for a shakeup in leadership at GSK to handle what the company described as a wealth of riches across the drug giant’s portfolio hindered by limited vision from top staff.

FDA+ roundup: Bs­U­FA III ready for show­time, court tells FDA to re-work com­pound­ing plan, new guid­ance up­dates and more

The FDA has now spelled out what exactly will be included in the third iteration of Biosimilar User Fee Act (BsUFA) from 2023 through 2027, which similarly to the prescription drug deal, sets fees that industry has to pay for submitting applications, in exchange for firm timelines that the agency must meet.

This latest deal includes several sweeteners for the biosimilar industry, which has yet to make great strides in the US market, with shorter review timelines for safety labeling updates and updates to add or remove an indication that does not contain efficacy data.

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Joshua Liang, Clover Biopharmaceuticals CEO

With world still in sore need of dos­es, Clover says its Covid-19 vac­cine is 67% ef­fec­tive in Phase III

With concerns about the Delta variant rising and much of the world still in desperate need of vaccine doses, a Chinese biotech announced Wednesday that a new shot has shown positive results in a large trial against Covid-19, including new variants.

Clover Biopharmaceuticals announced Wednesday that its vaccine candidate showed 79% efficacy against the Delta variant in a Phase II/III trial dubbed Spectra, and 67% effective against Covid-19 overall.