As­traZeneca throws down the gaunt­let with a PhI­II vic­to­ry in head-to-head PARP war with Tesaro

Sean Bo­hen, As­traZeneca

As­traZeneca has post­ed an­oth­er suc­cess in its cam­paign to ex­pand the use of its PARP in­hibitor Lyn­parza (ola­parib).

In what has be­come a head-to-head show­down with Tesaro, which has a ri­val PARP un­der re­view at the FDA, As­traZeneca to­day her­ald­ed a top-line suc­cess for Lyn­parza in a Phase III study of HER2-neg­a­tive metasta­t­ic breast can­cer har­bor­ing germline BR­CA1 or BR­CA2 mu­ta­tions.

Like Tesaro, As­traZeneca’s piv­otal study fo­cused on a com­par­i­son with physi­cian’s choice of chemother­a­pies, with Lyn­parza com­ing out ahead on pro­gres­sion-free sur­vival.

Lyn­parza got an ear­ly start in the mar­ket, thanks to FDA re­view­ers who were will­ing to look past the rel­a­tive­ly weak da­ta that As­traZeneca $AZN had post­ed for this drug. Richard Paz­dur’s team was anx­ious to get a PARP in­to the mar­ket for ovar­i­an can­cer, where Tesaro is lin­ing up its first shot on their fran­chise drug. A few back­ers on the sell side have pro­ject­ed bil­lions in peak sales for Tesaro’s drug, but they’ll have to get around As­traZeneca to get it.

As we re­port­ed a few days ago, ni­ra­parib sits high on a list of 15 po­ten­tial block­busters ready to hit the mar­ket this year, with 2022 sales rev­enue pro­ject­ed at $1.8 bil­lion for the ovar­i­an can­cer mar­ket. And that has kept the fo­cus on on­go­ing buzz about a po­ten­tial buy­out for Tesaro.

An­a­lysts will have to wait for the ac­tu­al da­ta, though, on an in­di­ca­tion that they say could be worth a block­buster bil­lion dol­lars in an­nu­al rev­enue for Tesaro. Sea­mus Fer­nan­dez called it a clear win for the phar­ma gi­ant:

This is the first Phase 3 read­out for a PARP in­hibitor in breast can­cer and will like­ly have pos­i­tive read-through for sim­i­lar­ly de­signed tri­als of PFE’s (MP) ta­la­zoparib (EM­BRA­CA tri­al; da­ta ex­pect­ed in 1H:17) and TSRO’s (MP) ni­ra­parib (BRA­VO tri­al; da­ta ex­pect­ed in 2H:17). Im­por­tant­ly, this rep­re­sents a win for AZN, which is build­ing its DNA Dam­age Re­sponse (DDR) port­fo­lio around Lyn­parza, as well as pro­vid­ing the first val­i­da­tion for the PARP in­hibitor class out­side of ovar­i­an can­cer. We con­tin­ue to view AZN as our top pick with a num­ber of high-im­pact cat­a­lysts on the hori­zon. Re­it­er­ate OP.

Shares of As­traZeneca jumped 1.7% on the news.

The suc­cess is a key win for As­traZeneca, which has been work­ing hard to fol­low up on Lyn­parza’s ap­proval with sol­id ev­i­dence of its broad­er po­ten­tial. The drug has proven to be one of the few big bright spots for the phar­ma gi­ant as it awaits com­bo da­ta on the check­point in­hibitor dur­val­um­ab and treme­li­mum­ab.

These aren’t the on­ly two PARPs in the pipeline. Pfiz­er ac­quired ta­la­zoparib in its $14 bil­lion buy­out of Medi­va­tion while Clo­vis achieved an ap­proval for Rubra­ca last De­cem­ber.

As­traZeneca CMO Sean Bo­hen said:

These re­sults are pos­i­tive news for pa­tients with BR­CA-mu­tat­ed metasta­t­ic breast can­cer, a dis­ease with a high un­met need, and are the first pos­i­tive Phase III da­ta for a PARP in­hibitor be­yond ovar­i­an can­cer. This is high­ly en­cour­ag­ing for the de­vel­op­ment of our broad port­fo­lio which aims to treat mul­ti­ple can­cers by tar­get­ing DNA dam­age re­sponse path­ways.

A new era of treat­ment: How bio­mark­ers are chang­ing the way we think about can­cer

AJ Patel was recovering from a complicated brain surgery when his oncologist burst into the hospital room yelling, “I’ve got some really great news for you!”

For two years, Patel had been going from doctor to doctor trying to diagnose his wheezing, only to be dealt the devastating news that he had stage IV lung cancer and only six months to live. And then they found the brain tumors.

“What are you talking about?” Patel asked. He had never seen an oncologist so happy.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Ted White, Verrica Pharmaceuticals CEO

'Hands may be tied': FDA slaps Ver­ri­ca with 3rd CRL due to prob­lems with con­tract man­u­fac­tur­er

The FDA has rejected Verrica Pharmaceuticals’ skin disease treatment for a third time — and once again the contract manufacturer is to blame.

The biotech emphasized that the only deficiency in the complete response letter is related to a general reinspection of the CMO, Sterling Pharmaceuticals, and has nothing to do specifically with its drug-device; the rest of the NDA is good to go.

CEO Ted White said the company is “extremely disappointed,” but will keep working toward approval.

Michael Corbo, Pfizer CDO of inflammation & immunology

UP­DAT­ED: Plan­ning ahead for crowd­ed ul­cer­a­tive col­i­tis mar­ket, Pfiz­er spells out PhI­II da­ta on $6.7B Are­na drug

Pfizer has laid out the detailed results behind its boast that etrasimod — the S1P receptor modulator at the center of its $6.7 billion buyout of Arena Pharma — is the winner of the class, potentially leapfrogging an earlier entrant from Bristol Myers Squibb.

Pivotal data from the ELEVATE program in ulcerative colitis — which consists of two Phase III trials, one lasting 52 weeks and the other just 12 weeks — illustrate an “encouraging balance of efficacy and safety,” according to Michael Corbo, chief development officer of inflammation & immunology at Pfizer. The company is presenting the results as a late breaker at Digestive Disease Week.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

An NYU surgeon transplants an engineered pig kidney into the outside of a brain-dead patient (Joe Carrotta/NYU Langone Health)

'Xeno­trans­plan­ta­tion is com­ing': New NE­JM pa­per gives de­tailed look in­to 2 pig-to-hu­man kid­ney trans­plant cas­es

The thymokidney is a curious organ, if you could call it that. It’s a sort of Frankensteinian creation — a system of pig thymus embedded underneath the outer layer of a pig’s kidney, made for human transplantation.

In the first case of pig-to-human xenotransplantation of a kidney into a brain-dead patient, the thymokidney quietly featured front and center.

In that experiment, which took place in September of last year, NYU researchers led by Robert Montgomery sutured a pig thymokidney onto the leg of a brain-dead 66-year-old woman. That case was widely reported on by a horde of major media outlets, including the New York Times, the BBC, and an in-depth feature by USA Today.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

Vlad Coric, Biohaven CEO

UP­DAT­ED: Fresh off $11.6B sale to Pfiz­er, New Bio­haven hits Phase III set­back just weeks af­ter Vlad Coric chalked up promise

When Pfizer bought up Biohaven’s migraine portfolio in the largest M&A deal of the year earlier this month, Biohaven CEO Vlad Coric promised the rest of the pipeline, which will live on under the umbrella of New Biohaven, still has a lot to offer. But that vision took a dent Monday as the drugmaker revealed it’s once again flopped on troriluzole.

The glutamate regulator failed to meet the primary endpoint on a Phase III study in patients with spinocerebellar ataxia, an inherited disorder that impairs a person’s ability to walk, speak and swallow. SCA can also lead to premature death.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

Mihael Polymeropoulos, Vanda Pharmaceuticals CEO

Phar­ma com­pa­ny con­tin­ues its FDA law­suit spree, this time af­ter agency de­nies fast-track des­ig­na­tion

Vanda Pharmaceuticals is making a name for itself, at least in terms of suing the FDA.

The DC-headquartered firm on Monday filed its latest suit against the agency, with the company raising concerns over the FDA’s failure to grant a fast track designation for Vanda’s potential chronic digestive disorder drug tradipitant, which is a neurokinin 1 receptor antagonist.

Specifically, Vanda said FDA’s “essential point” in its one-page denial letter on the designation pointed to “the lack of necessary safety data,” which was “inconsistent with the criteria for … Fast Track designation.”

Mod­er­na seeks to dis­miss Al­ny­lam suit over Covid-19 vac­cine com­po­nent, claim­ing wrong venue

RNAi therapeutics juggernaut Alnylam Pharmaceuticals made a splash in March when it sued and sought money from both Pfizer and Moderna regarding their use of Alnylam’s biodegradable lipids, which Alnylam claims have been integral to the way both companies’ mRNA-based Covid-19 vaccines work.

But now, Moderna lawyers are firing back, telling the same Delaware district court that Alnylam’s claims can only proceed against the US government in the Court of Federal Claims because of the way the company’s contract is set up with the US government. The US has spent almost $10 billion on Moderna’s Covid-19 vaccine so far.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

(Credit: Shutterstock)

Cracks in the fa­cade: Is phar­ma's pan­dem­ic ‘feel good fac­tor’ wan­ing?

The discordant effects of the Covid-19 pandemic on pharma reputation continues. While the overall industry still retains a respectable halo from its Covid-19 quick response and leadership, a new patient group study reveals a different story emerging in the details.

On one hand, US patient advocacy groups rated the industry higher-than-ever overall. More than two-thirds (67%) of groups gave the industry a thumbs up for 2021, a whopping 10 percentage point increase over the year before, according to the PatientView annual study, now in its 9th year.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 142,600+ biopharma pros reading Endpoints daily — and it's free.

Saqib Islam, SpringWorks CEO

Pfiz­er spin­out Spring­Works will ship its first drug to the FDA be­fore year’s end with PhI­II win

SpringWorks Therapeutics thinks it has cemented the backbone for its first “pipeline-in-a-product” oncology treatment and will send it to the FDA before the clock strikes 2023 with a Phase III win on Tuesday.

The oral gamma secretase inhibitor, dubbed nirogacestat, beat placebo on the primary goal of progression-free survival in adults with progressing desmoid tumors.

The soft-tissue tumors can lead to long-lasting pain, disfigurement and amputation, and there are currently no approved meds for the rare oncology indication. The tumors typically impact patients aged 20 to 44 years old and disproportionately affect women at rates 2 to 3 times higher, with up to a total of 1,650 new cases diagnosed in the US annually, according to SpringWorks.