J&J’s stel­lar prostate can­cer da­ta sig­nals the like­li­hood of a broad­er mar­ket ap­proval, as Pfiz­er ri­val strug­gles

CHICA­GO — J&J will be look­ing to ex­pand its block­buster mar­ket for Zyti­ga (abi­raterone) af­ter post­ing stel­lar da­ta at AS­CO show­ing that the drug com­bined with stan­dard hor­mone ther­a­py reg­is­tered a ma­jor im­prove­ment in pro­gres­sion-free sur­vival among new­ly di­ag­nosed pa­tients with metasta­t­ic prostate can­cer.

The LAT­I­TUDE study da­ta demon­strat­ed that the com­bi­na­tion ther­a­py de­liv­ered an av­er­age stretch of 33 months with­out the dis­ease wors­en­ing, com­pared to 14.8 months for stan­dard hor­mone ther­a­py. Zyti­ga plus pred­nisone in com­bi­na­tion with ADT de­creased the risk of pro­gres­sion or death by 53% com­pared to place­bo plus ADT in pa­tients with mH­N­PC. And while over­all sur­vival was not reached yet for the Zyti­ga com­bo, the com­par­i­son arm came in at 34.7 months.

J&J $JNJ has been duk­ing it out with Pfiz­er’s Xtan­di — re­cent­ly ac­quired in the $14 bil­lion Medi­va­tion deal — in the area of prostate can­cer, where both drugs are cred­it­ed with a ma­jor im­prove­ment in the stan­dard of care for prostate can­cer.

The progress for J&J will like­ly be viewed as Pfiz­er’s loss. The phar­ma gi­ant has post­ed shrink­ing sales for Xtan­di since it com­plet­ed the buy­out. And its fol­low-on da­ta hasn’t been good.

Karim Fizazi, Uni­ver­si­ty Paris-Sud

Late last year Pfiz­er and its part­ners at Astel­las con­ced­ed that Xtan­di com­bined with Zyti­ga and pred­nisone failed to bend the curve on pro­gres­sion-free sur­vival for chemo-naïve pa­tients whose dis­ease had pro­gressed fol­low­ing treat­ment with Xtan­di, com­pared with a group of pa­tients treat­ed with Zyti­ga and pred­nisone alone. The in­ves­ti­ga­tors had been look­ing for a ra­tio­nale to con­tin­ue treat­ment with Xtan­di, which would have ex­pand­ed its block­buster mar­ket even fur­ther.

Said J&J’s prin­ci­pal in­ves­ti­ga­tor Dr. Karim Fizazi:

This is im­por­tant new in­for­ma­tion, as not all pa­tients re­spond well to the cur­rent stan­dard of care. LAT­I­TUDE sug­gests that abi­raterone ac­etate plus pred­nisone, in com­bi­na­tion with an­dro­gen de­pri­va­tion ther­a­py, can of­fer a new and much-need­ed op­tion for pa­tients with high-risk new­ly di­ag­nosed mH­N­PC.

Scoop: Boehringer qui­et­ly shut­ters a PhII for one of its top drugs — now un­der re­view

Boehringer Ingelheim has quietly shut down a small Phase II study for one of its lead drugs.

The private pharma player confirmed to Endpoints News that it had shuttered a study testing spesolimab as a therapy for Crohn’s patients suffering from bowel obstructions.

A spokesperson for the company tells Endpoints:

Taking into consideration the current therapeutic landscape and ongoing clinical development programs, Boehringer Ingelheim decided to discontinue our program in Crohn’s disease. It is important to note that this decision is not based on any safety findings in the clinical trials.

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Lina Gugucheva, NewAmsterdam Pharma CBO

Phar­ma group bets up to $1B-plus on the PhI­II res­ur­rec­tion of a once dead-and-buried LDL drug

Close to 5 years after then-Amgen R&D chief Sean Harper tamped the last spade of dirt on the last broadly focused CETP cholesterol drug — burying their $300 million upfront and the few remaining hopes for the class with it — the therapy has been fully resurrected. And today, the NewAmsterdam Pharma crew that did the Lazarus treatment on obicetrapib is taking another big step on the comeback trail with a €1 billion-plus regional licensing deal, complete with close to $150 million in upfront cash.

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How pre­pared is bio­phar­ma for the cy­ber dooms­day?

One of the largest cyberattacks in history happened on a Friday, Eric Perakslis distinctly remembers.

Perakslis, who was head of Takeda’s R&D Data Sciences Institute and visiting faculty at Harvard Medical School at the time, had spent that morning completing a review on cybersecurity for the British Medical Journal. Moments after he turned it in, he heard back from the editor: “Have you heard what’s going on right now?”

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Scoop: Roche scraps one of two schiz­o­phre­nia PhII tri­als af­ter fail­ing the pri­ma­ry end­point

Roche has terminated one of two Phase II trials testing its drug ralmitaront in patients with schizophrenia, the Big Pharma confirmed to Endpoints News.

The study was terminated last month, according to a June 22 update to the registry on clinicaltrials.gov. Begun in September 2020, the trial was looking at ralmitaront in patients with acute schizophrenia. The trial enrolled 286 patients out of an originally planned 308.

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Matt Gline, Roivant CEO (John Sciulli/Getty Images for GLG)

Roivant chops sick­le cell gene ther­a­py, der­ma­tol­ogy drugs to fo­cus on 'high­er val­ue pro­ject­s'

Roivant is sweeping a suite of drugs, including a gene therapy for sickle cell disease already in the clinic, out of its pipeline.

Six programs from four of its “vants” are being wound down as part of “a company-wide cost optimization and pipeline reprioritization initiative to reduce our expected operating expenses and prioritize our capital resources.”

When reached by Endpoints News, a spokesperson said, “We don’t anticipate a material reduction in headcount but we will likely reassign some folks to higher value projects as part of winding down specific programs.”

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Laurence Reid, Decibel CEO

Still in pre­clin­i­cal test­ing for ear gene ther­a­pies, Deci­bel touts small snap­shot of chemo-in­duced hear­ing loss drug

Though Decibel Therapeutics has largely pivoted toward gene therapies for the inner ear, its lead clinical candidate simply aims to protect cancer patients from chemotherapy-induced hearing loss. On Tuesday, the biotech presented its first efficacy data for the program, and execs like what they see.

Decibel reported interim results from a Phase Ib study showing the experimental drug, dubbed DB-020, largely protected a small group of patients from losing their hearing. Researchers used a particularly unique study design, administering the compound in one of each patients’ ears before they received cisplatin chemotherapy and placebo in the other.

Years af­ter link­ing arms with Bris­tol My­ers and both Mer­cks, Sutro finds its lat­est part­ner in Tokyo

Astellas and Sutro Biopharma are linking arms on a new field of antibody-drug conjugates that they hope will improve upon existing cancer immunotherapies.

The Tokyo pharma will dole out $90 million in cash for the collaboration, the companies said Monday afternoon. That upfront payment will extend the South San Francisco biotech’s runway from late 2023 into the first half of 2024, Cowen analysts noted.

Pearl Huang, Dunad Therapeutics CEO (Ken Richardson, PR Newswire)

Long­time biotech leader Pearl Huang takes the reins as CEO of No­var­tis-backed up­start

It has only been a few months since Pearl Huang exited the top seat at Cygnal Therapeutics, but now she’s back at the helm of another biotech.

After taking a few months off — passing an exam in that time to get her captain’s license from the US Coast Guard — she’s been named CEO of Dunad Therapeutics, a biotech focused on developing a small molecule covalent therapies that was founded in 2020. Huang told Endpoints News that two factors attracted her to going back to the c-suite: the company’s technology and its co-founders.

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Deborah Dunsire, Lundbeck CEO

Af­ter a 5-year re­peat PhI­II so­journ, Lund­beck and Ot­su­ka say they're fi­nal­ly ready to pur­sue OK to use Rex­ul­ti against Alzheimer's ag­i­ta­tion

Five years after Lundbeck and their longtime collaborators at Otsuka turned up a mixed set of Phase III data for Rexulti as a treatment for Alzheimer’s dementia-related agitation, they’ve come through with a new pivotal trial success they believe will finally put them on the road to an approval at the FDA. And if they’re right, some analysts believe they’re a short step away from adding more than $500 million in annual sales for the drug, already approved in depression and schizophrenia.

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