Eli Lil­ly wins a quick OK for new sar­co­ma drug olara­tum­ab

Richard Paz­dur, FDA

Eli Lil­ly has won an ac­cel­er­at­ed FDA ap­proval of its soft tis­sue sar­co­ma drug olara­tum­ab with set of pos­i­tive re­sults from a small mid-stage study. Lil­ly plans to sell the drug as Lartru­vo to a slice of pa­tients for front­line use  — the first such ap­proval to come along in decades for this dis­ease.

The drug tar­gets PDGF re­cep­tors which cause tu­mor growth.

The agency’s green light comes just a month af­ter the EU’s CHMP of­fered a pos­i­tive opin­ion about a sim­i­lar move in Eu­rope, set­ting up a like­ly transAt­lantic sweep for Lil­ly, which has been pour­ing re­sources in­to its on­col­o­gy pipeline in re­cent years.

The FDA ap­proved the drug, on­ly its 18th OK so far this year, in com­bi­na­tion with dox­oru­bicin among pa­tients who can’t be treat­ed by ra­di­a­tion or surgery and in a group with a type of STS that can be treat­ed with the chemo an­thra­cy­cline.

“For these pa­tients, Lartru­vo, added to dox­oru­bicin, pro­vides a new treat­ment op­tion,” said Richard Paz­dur, MD, di­rec­tor of the Of­fice of Hema­tol­ogy and On­col­o­gy Prod­ucts in the FDA’s Cen­ter for Drug Eval­u­a­tion and Re­search and act­ing di­rec­tor of the FDA’s On­col­o­gy Cen­ter of Ex­cel­lence. “This is the first new ther­a­py ap­proved by the FDA for the ini­tial treat­ment of soft tis­sue sar­co­ma since dox­oru­bicin’s ap­proval more than 40 years ago.”

Lil­ly, which has be­gun to rack up a few new drug ap­provals af­ter a long drought in the clin­ic, was able to present stats show­ing that the me­di­an sur­vival rate for pa­tients hit 26.5 months for the com­bo com­pared to 14.7 months for pa­tients who re­ceived dox­oru­bicin alone. In­ves­ti­ga­tors al­so post­ed a me­di­an pro­gres­sion-free sur­vival time of 8.2 months for the com­bo com­pared to 4.4 months for pa­tients who re­ceived on­ly dox­oru­bicin. Tu­mor shrink­age reg­is­tered at 18.2 per­cent against 7.5 per­cent.

This OK marks an­oth­er im­por­tant step for­ward for Lil­ly, which had been a peren­ni­al lag­gard in R&D. Lat­er this year Lil­ly will fol­low up with its lat­est round of Phase III da­ta for solanezum­ab, its big ex­per­i­men­tal ther­a­py for Alzheimer’s. Most an­a­lysts ex­pect mixed da­ta at best as Lil­ly looks to break the lock on new Alzheimer’s meds af­ter a decade-long run of fail­ures.

Back in March Lil­ly won an ap­proval for the pso­ri­a­sis drug Taltz (ix­ek­izum­ab) and still faces a de­ci­sion on baric­i­tinib for rheuma­toid arthri­tis as well as the CDK 4/6 drug abe­maci­clib, now sched­uled to wrap a Phase III next year as Lil­ly is forced to wait for the full da­ta set.

Jean-Paul Clozel, Idorsia CEO (Patrick Straub/Keystone via AP Images)

Idor­si­a's brain bleed drug flunks PhI­II tri­al, a decade af­ter pre­vi­ous flop

Idorsia’s long journey with clazosentan came to an abrupt “unexpected result” Monday morning with a Phase III flop.

The Swiss biopharma said the drug did not meet the main goal of the late-stage REACT study, conducted in the US, Canada and Europe since early 2019.

The 409-patient trial tested the intravenous drug’s ability to prevent complications due to delayed cerebral ischemia following aneurysmal subarachnoid hemorrhage (aSAH), in which blood vessels in the brain narrow and blood accumulates around the brain’s surface, which then dials up the pressure on the brain.

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Kenji Yasukawa, Astellas Pharma CEO (Photographer: Akio Kon/Bloomberg via Getty Images)

Astel­las taps chief strat­e­gy of­fi­cer as next CEO to 'go on the ag­gres­sive'

Five years into its big R&D revamp, Astellas says it’s time for a changing of the guard.

Kenji Yasukawa, who took over as president and CEO in 2018, will step down to become chairman of the board in April, making room for Naoki Okamura to take over. Okamura joined the company in 1986 and has served in a variety of finance, business and strategy roles, including most recently as chief strategy officer.

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Clin­i­cal tri­al di­ver­si­ty da­ta show mis­match be­tween en­roll­ment and dis­ease preva­lence, GSK says

A lack of diversity in clinical trials has persisted despite decades of initiatives to try to turn the tide.

In a recent review of 17 years of clinical trials, drugmaker GSK found that there were some mismatches between the demographics of its US-based trials and how prevalent diseases were in those populations.

The results, the company says, will help GSK and others design studies that better represent epidemiological rates within races and ethnicities.

The Big Phar­ma dis­card pile; Lay­offs all around while some biotechs bid farewell; New Roche CEO as­sem­bles top team; 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.

With earnings seasons in full swing, we’ve listened in on all the calls so you don’t have to. But news is popping up from all corners, so make sure you check out our other updates, too.

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Ma­gen­ta halts stem cell work and may sell it­self fol­low­ing pa­tient death, clin­i­cal hold

Magenta Therapeutics said it is halting work on its stem cell transplant drug pipeline and may sell itself, a week after the company reported the death of a patient in an early stage trial of its antibody-drug conjugate.

The Cambridge, MA-based company said it will conduct a “review of strategic alternatives,” and that could include an “acquisition, merger, business combination, or other transaction.”

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How to use ex­ter­nal con­trols: FDA spells out think­ing in new draft guid­ance

The use of real-world evidence to inform the FDA’s decision-making continues apace, with the agency releasing new draft guidance yesterday on how sponsors can compare outcomes of trial participants receiving a test treatment with outcomes in a group of people external to the trial.

The practice of externally controlled trials is common, particularly in oncology or other difficult areas where it’s not ethical or feasible to use internal controls.

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The Big Phar­ma axe: Mer­ck cuts chikun­gun­ya vax, Bris­tol My­ers drops Cy­tomX-part­nered pro­gram, and more

As fourth quarter earnings come in, Big Pharmas are disclosing changes to their pipelines during their investor calls, and sometimes more quietly in presentation appendices.

Merck dropped its chikungunya vaccine candidate, which completed a Phase II study. Merck acquired the vaccine through its purchase of Themis Bioscience in 2020. In developing a vaccine for chikungunya, a mosquito-borne virus, Valneva is the frontrunner, as it submitted its vaccine to the FDA at the end of December.

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Goldfinch Bio CEO Tony Johnson (L) and Karuna Therapeutics CEO Bill Meury

Karuna li­cens­es Goldfinch as­sets to com­pete with Boehringer In­gel­heim in neu­ro­science

Karuna Therapeutics is looking to compete with Boehringer Ingelheim on depression and anxiety with a new license to Goldfinch Bio’s assets, starting with $15 million to the shuttered biotech.

Karuna steps into an arena already being tested by Boehringer in multiple Phase II studies — the two are targeting transient receptor potential canonical 4 and 5, or TRPC4/5, which is thought to have a role in neuroscience indications. Goldfinch’s asset went through a Phase II in kidney diseases, but Karuna’s sights are set on mood and anxiety disorders for now.

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Roche's headquarters in Basel, Switzerland (Kyle LaHucik for Endpoints News)

Roche ditch­es fi­nal PhI­II for can­cer hope­ful, re­ports set­back for key drug in $1.4B buy­out

Over the past few years, Roche has released news about its AKT inhibitor ipatasertib in drips — most of them negative. The drug yielded mixed data in a key prostate cancer trial, Phase III flops in triple-negative breast cancer forced the pharma giant to pull the plug there, and in mid-2022 Roche trimmed two more early-stage indications in prostate cancer after completing the trials.

Now, the last piece of the program is gone.

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