Pfiz­er, Mer­ck KGaA ce­ment Baven­cio blad­der can­cer win with OS da­ta — while carv­ing an­oth­er niche in rare can­cer

Pfiz­er and Mer­ck KGaA have de­tailed the Phase III da­ta that in­spired FDA reg­u­la­tors to des­ig­nate Baven­cio a “break­through” for first-line ad­vanced blad­der can­cer and of­fered an ear­ly glance at how the PD-L1 can help pa­tients with a rare gy­ne­co­log­i­cal can­cer — carv­ing out nich­es in the check­point space for it­self af­ter be­ing shut out of nu­mer­ous oth­ers.

In JAVELIN Blad­der 100, Baven­cio led to a 31% re­duc­tion in risk of death com­pared to stan­dard care alone. It al­so ex­tend­ed me­di­an sur­vival by more than sev­en months — a his­toric feat in this set­ting, ac­cord­ing to in­ves­ti­ga­tors at Queen Mary Uni­ver­si­ty of Lon­don.

All 700 pa­tients in the tri­al com­plet­ed chemother­a­py be­fore get­ting ran­dom­ized to ei­ther main­te­nance ther­a­py with Baven­cio or reg­u­lar check­ing. Those on the drug arm saw mOS of 21.4 months, com­pared with 14.3 months on the com­para­tor group.

Around one in 10 pa­tients stopped the drug due to treat­ment prob­lems, though the com­pa­nies said side ef­fects were in line with ex­pec­ta­tions.

“This high­lights the po­ten­tial ben­e­fits of a main­te­nance ap­proach with avelum­ab in pa­tients to pro­long their lives fol­low­ing chemother­a­py,” Thomas Powles, a study lead and pro­fes­sor of gen­i­touri­nary on­col­o­gy at Queen Mary, said in a state­ment.

The find­ings could be “prac­tice-chang­ing,” he added, es­pe­cial­ly con­sid­er­ing these pa­tients have can­cer that has spread be­yond the blad­der.

The drug was al­ready sanc­tioned, un­der ac­cel­er­at­ed ap­proval, for use in pa­tients fol­low­ing dis­ease pro­gres­sion — an OK ce­ment­ed by tu­mor re­sponse and du­ra­tion of re­sponse back in 2017. Pfiz­er and Mer­ck KGaA have sub­mit­ted an ap­pli­ca­tion for a full OK.

With As­traZeneca’s PD-L1 Imfinzi fail­ing to prove it­self in a piv­otal study (de­spite hav­ing an ac­cel­er­at­ed ap­proval), they have few ri­vals to wor­ry about.

That’s like­ly the same mind­set that the two phar­ma gi­ants are tak­ing in­to ges­ta­tion­al tro­phoblas­tic tu­mors, a kind of ab­nor­mal growth of cells in­side a woman’s uterus. It’s a small Phase II study that en­rolled on­ly 15 pa­tients, but re­searchers were en­cour­aged by how Baven­cio kept the dis­ease from re­turn­ing in eight of them. One pa­tient even went on to have a healthy preg­nan­cy.

The pa­tients en­rolled in­to the Phase II are re­sis­tant to mono­chemother­a­py and must en­dure tox­ic chemo reg­i­mens. The main ef­fi­ca­cy mea­sure was the nor­mal­iza­tion of a hor­mone known as hu­man chori­on­ic go­nadotropin.

No oth­er im­munother­a­py has been test­ed in GTT pa­tients be­fore, sci­en­tists wrote in an ab­stract, but PD-L1 is ex­pressed in all sub­types of this can­cer.

A group of re­searchers in South Ko­rea have al­so planned a sim­i­lar study with Mer­ck’s Keytru­da, ac­cord­ing to clin­i­cal­tri­

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.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Ex­elix­is pulls a sur­prise win in thy­roid can­cer just days ahead of fi­nal Cabome­tyx read­out

Exelixis added a thyroid cancer indication to its super-seller Cabometyx’s label on Friday — months before the FDA was expected to make a decision, and days before the company was set to unveil the final data at #ESMO21.

At a median follow-up of 10.1 months, differentiated thyroid cancer patients treated with Cabometyx (cabozantinib) lived a median of 11 months without their disease worsening, compared to just 1.9 months for patients given a placebo, Exelixis said on Monday.

Dave Lennon, former president of Novartis Gene Therapies

Zol­gens­ma patent spat brews be­tween No­var­tis and Re­genxbio as top No­var­tis gene ther­a­py ex­ec de­parts

Regenxbio, a small licensor of gene therapy viral vectors spun out from the University of Pennsylvania, is now finding itself in the middle of some major league patent fights.

In addition to a patent suit with Sarepta Therapeutics from last September, Novartis, is now trying to push its smaller partner out of the way. The Swiss biopharma licensed Regenxbio’s AAV9 vector for its $2.1 million spinal muscular atrophy therapy Zolgensma.

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Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.

Ex-My­lan em­ploy­ee pleads guilty to in­sid­er trad­ing, il­le­gal­ly deal­ing on FDA ap­provals, earn­ings and Up­john merg­er

A former Mylan IT executive pleaded guilty Friday to an insider trading scheme where he bought and sold stock options on another executive’s advice.

Prosecutors secured the plea from Dayakar Mallu, Mylan’s former VP of global operations information technology, after uncovering the plan. Mallu collaborated with an unnamed “senior manager,” the SEC said, to trade options ahead of Mylan public announcements regarding FDA approvals, revenue reports and its merger with the Pfizer generics subsidiary Upjohn. The two subsequently shared profits.

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As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

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Den­mark's Gubra to col­lab­o­rate with Bay­er on pep­tides; Sam­sung and Bio­gen re­ceive FDA ap­proval for Lu­cen­tis biosim­i­lar

Danish biotech Gubra announced a research collaboration and license agreement with Bayer to develop peptide therapeutics to treat cardiorenal diseases. The collaboration will utilize Gubra’s peptide drug discovery platform to identify potential candidates.

This is not the first time Gubra has partnered with a company on peptide therapeutics — they partnered with Boehringer Ingelheim back in 2017 to create peptide therapeutics to treat obesity.