Jakafi failed the pri­ma­ry end­point in a Covid-19 study. But In­cyte is still go­ing to FDA with a com­pas­sion­ate use pitch

Jakafi dis­ap­point­ed In­cyte once when it failed to pre­vent se­vere com­pli­ca­tions of Covid-19. The JAK in­hibitor has fall­en short again in an­oth­er Phase III study, fail­ing to keep a more crit­i­cal sub­group of pa­tients from dy­ing.

The DE­VENT study re­cruit­ed 211 peo­ple with acute res­pi­ra­to­ry dis­tress syn­drome on me­chan­i­cal ven­ti­la­tion, and set out to see if ei­ther a 5mg dose or a 15mg dose of Jakafi could re­duce mor­tal­i­ty through day 29 com­pared to stan­dard of care alone. In to­day’s world, that means remde­sivir for 55% of study pa­tients and cor­ti­cos­teroids for 90%.

Adding Jakafi, in­ves­ti­ga­tors found, did not im­prove that met­ric in the over­all study pop­u­la­tion by a sta­tis­ti­cal­ly sig­nif­i­cant mar­gin when you ad­just for ARDS sever­i­ty be­tween the two treat­ment arms ver­sus place­bo.

In­cyte re­port­ed an odds ra­tio of 0.42 in the 5mg arm and 0.46mg in the 15mg arm, re­spec­tive­ly, with the con­fi­dence in­ter­val cross­ing over 1.0 on the up­per bounds.

They found hope, how­ev­er, in the US study pop­u­la­tion: There was a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in mor­tal­i­ty in each of the arms, with odds ra­tios of 0.39 (46.7% ver­sus 66.7%, p=0.189) and 0.43 (47.1% vs 66.7%, p=0.0215), re­spec­tive­ly. With 191 pa­tients, that co­hort ac­count­ed for the ma­jor­i­ty of the study pop­u­la­tion.

Dig­ging even deep­er to try and pull pos­i­tive num­bers, the com­pa­ny added that a post hoc  analy­sis pool­ing both the dos­es to­geth­er would yield a sta­tis­ti­cal­ly sig­nif­i­cant re­sult (odds ra­tio 0.47, 53.6% vs 70.7%, p=0.0244) — al­though the con­fi­dence in­ter­val came close to the edge at 0.996.

Steven Stein

While In­cyte didn’t spec­i­fy next de­vel­op­ment or reg­u­la­to­ry steps, all of that ap­par­ent­ly sup­ports launch­ing a com­pas­sion­ate use pro­gram for pa­tients with Covid-19 as­so­ci­at­ed ARDS, which is what they will be propos­ing to the FDA.

“There re­mains a sig­nif­i­cant un­met med­ical need for treat­ments that may po­ten­tial­ly im­prove sur­vival out­comes for pa­tients suf­fer­ing from se­vere COVID-19 re­lat­ed com­pli­ca­tions, specif­i­cal­ly those re­quir­ing me­chan­i­cal ven­ti­la­tion,” In­cyte CMO Steven Stein said in a state­ment.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

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.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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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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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.

Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a rather narrow market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

FDA hands ac­cel­er­at­ed nod to Seagen, Gen­mab's so­lo ADC in cer­vi­cal can­cer, but com­bo stud­ies look even more promis­ing

Biopharma’s resident antibody-drug conjugate expert Seagen has scored a clutch of oncology approvals in recent years, finding gold in what are known as “third-gen” ADCs. Now, another of their partnered conjugates is ready for prime time.

The FDA on Monday handed an accelerated approval to Seagen and Genmab’s Tivdak (tisotumab vedotin-tftv, or “TV”) in second-line patients with recurrent or metastatic cervical cancer who previously progressed after chemotherapy rather than PD-(L)1 systemic therapy, the companies said in a release.

Mi­rati's KRAS drug looks like the ear­ly fa­vorite in colon can­cer with new da­ta, putting the pres­sure square on Am­gen

With Amgen already providing proof-of-concept for KRAS inhibitors with its sotorasib, Mirati Therapeutics is piecing together a follow-up effort in lung cancer with data it thinks are superior. But in colon cancer, where solo sotorasib has turned in a dud, Mirati may now have a strong case for superiority.

Mirati’s adagrasib, dosed solo or in combination with chemotherapy cetuximab, showed numerically higher response rates than sotorasib solo and as part of a combination study in a similar patient population also revealed this week at #ESMO21. Mirati’s data were presented as part of a cohort update from the Phase II KRYSTAL-1 study testing adagrasib in a range of solid tumors harboring the KRAS-G12C mutation.

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