David Reese, Amgen

As teze­pelum­ab awaits FDA de­ci­sion, Am­gen and As­traZeneca tout more da­ta from the Phase III study

As As­traZeneca and Am­gen’s Dupix­ent chal­lenger awaits a de­ci­sion by the FDA, the com­pa­nies are tout­ing new da­ta they hope could bol­ster their case.

Re­searchers re­vealed ad­di­tion­al re­sults from a piv­otal Phase III tri­al for As­traZeneca and Am­gen’s teze­pelum­ab over the week­end, study­ing the treat­ment in se­vere, un­con­trolled asth­ma. In an ex­plorato­ry analy­sis look­ing at pa­tients with or with­out re­port­ed nasal polyps, teze­pelum­ab showed it can re­duce asth­ma ex­ac­er­ba­tion by 86% in the for­mer group and 52% in the lat­ter when com­pared to stan­dard of care.

“These re­sults fur­ther strength­en our con­fi­dence in teze­pelum­ab’s po­ten­tial to ad­dress a sig­nif­i­cant un­met need across a broad pop­u­la­tion of pa­tients with se­vere asth­ma, in­clud­ing those with co­mor­bid nasal polyps,” Am­gen R&D chief David Reese said in a state­ment.

The da­ta come two months af­ter teze­pelum­ab scored pri­or­i­ty re­view from reg­u­la­tors, with a de­ci­sion ex­pect­ed in the first quar­ter of next year.

Peak sales for the drug have been es­ti­mat­ed at $2.5 bil­lion, with some ear­ly es­ti­mates from 2018 go­ing as high as $4.5 bil­lion. While the larg­er fig­ure now ap­pears un­ten­able with the atopic der­mati­tis in­di­ca­tion hav­ing been scut­tled, and the small­er es­ti­mate doesn’t reach as high as the block­buster from Re­gen­eron and Sanofi — Dupix­ent raked in near­ly $4 bil­lion last year — teze­pelum­ab could still carve out a hefty slice of the mar­ket.

Sat­ur­day’s re­sults come from a Phase III study pub­lished in full back in May, in which teze­pelum­ab plus stan­dard of care “demon­strat­ed su­pe­ri­or­i­ty” across the pri­ma­ry and all key sec­ondary end­points com­pared to the stan­dard of care alone. When topline re­sults came the pre­vi­ous No­vem­ber, Reese played up the read­out de­spite lim­it­ed pub­lic da­ta, de­clar­ing he was “ab­solute­ly thrilled” with the study.

The com­pa­nies filled every­one in on the ac­tu­al topline da­ta in Feb­ru­ary of this year, say­ing teze­pelum­ab cut the rate of se­vere asth­ma at­tacks by 56% at the one-year mark com­pared with stan­dard of care alone.

Not every­thing has been smooth sail­ing for the drug, how­ev­er, giv­en month­ly as a sub­cu­ta­neous in­jec­tion. Af­ter flunk­ing two Phase II tri­als in AD, As­traZeneca re­vealed the pair had thrown in the tow­el on the con­di­tion in their sec­ond quar­ter up­date ear­li­er this sum­mer.

Ad­di­tion­al­ly, teze­pelum­ab whiffed on an­oth­er area Dupix­ent man­aged to lock down in asth­ma — re­duc­ing the num­ber of oral cor­ti­cos­teroids asth­ma pa­tients need­ed to take. Am­gen and As­traZeneca’s treat­ment failed to hit that mark in an­oth­er Phase III study, a re­sult Reese called “sur­pris­ing” in De­cem­ber 2020.

Cor­rec­tion: This ar­ti­cle has been cor­rect­ed to amend teze­pelum­ab’s method of de­liv­ery. It is giv­en via sub­cu­ta­neous in­jec­tion, not in­tra­venous in­fu­sion. 

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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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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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.