As­traZeneca cel­e­brates a PhI­II PARP suc­cess for Lyn­parza, putting pres­sure on Tesaro ri­val

As­traZeneca dropped one very big, tan­ta­liz­ing clue this morn­ing that will de­ter­mine the fate of its PARP in­hibitor Lyn­parza (ola­parib). As ri­val PARPs come up the pipeline from Tesaro, Clo­vis and Pfiz­er, the phar­ma gi­ant says that its Phase III ovar­i­an can­cer study came up with sta­tis­ti­cal­ly sig­nif­i­cant re­sults that beat out what we’ve seen so far.

“Im­por­tant­ly, the me­di­an PFS in the Lyn­parza arm of SO­LO-2 sub­stan­tial­ly ex­ceed­ed that ob­served in the Phase II main­te­nance study in pa­tients with plat­inum-sen­si­tive re­lapsed ovar­i­an can­cer (Study 19),” As­traZeneca $AZN said in a re­lease. In­ves­ti­ga­tors test­ed the drug as a main­te­nance monother­a­py com­pared with place­bo in pa­tients with plat­inum-sen­si­tive re­lapsed or re­cur­rent BR­CA-mu­tat­ed (BR­CAm) ovar­i­an can­cer.

And that’s all you’re go­ing to get right now, as in­ves­ti­ga­tors gath­er their da­ta for an up­com­ing sci­en­tif­ic con­fer­ence.

Lyn­parza’s ac­cel­er­at­ed ap­proval with shaky da­ta and a neg­a­tive pan­el vote is one of the best things that has hap­pened to that com­pa­ny since Pas­cal So­ri­ot took over. And they need to do bet­ter than the weak re­sults that got them over the fin­ish line if they ex­pect to pre­serve the win in the mar­ket.

The de­vel­op­ers in the field did not all go af­ter the same pa­tient pop­u­la­tion, which makes com­par­isons dif­fi­cult. How­ev­er, each new da­ta point is be­ing giv­en a care­ful eval­u­a­tion as the ri­val com­pa­nies look to divvy up the mar­ket. In par­tic­u­lar, any­thing that pol­ish­es Lyn­parza’s da­ta will be com­pared close­ly with Tesaro’s ni­ra­parib, al­so be­ing pitched as a sec­ond-line main­te­nance ther­a­py.

Jef­feries notes that the da­ta is like­ly to set up a head-to-head ri­val­ry be­tween As­traZeneca and Tesaro.

We await full re­sults SO­LO-2 at an as-yet-to-be-dis­closed med­ical meet­ing to com­pare the re­sults to those seen with TSRO’s (OP) ni­ra­parib in the gBR­CA­mut co­hort of the Phase 3 NO­VA tri­al. We ex­pect the ben­e­fit of the two drugs to be broad­ly sim­i­lar and as­sume this in our mod­el. While we cur­rent­ly ex­pect Lyn­parza and ni­ra­parib to split the mar­ket in gBR­CA­mut pa­tients, ni­ra­parib is like­ly to ben­e­fit from an ex­pand­ed in­di­ca­tion in­clud­ing ho­mol­o­gous re­com­bi­na­tion de­fi­cient (HRD) pos­i­tive pa­tients, and we al­so be­lieve like­ly HRD-neg­a­tive pa­tients as well.

Tesaro’s shares are down 3% in pre-mar­ket trad­ing.

It’s like­ly to be quite a dust­up. Pfiz­er spent $14 bil­lion to buy Medi­va­tion with its prostate can­cer drug as well as an ex­per­i­men­tal PARP, ta­la­zoparib. Clo­vis $CLVS had to grap­ple with con­sid­er­able skep­ti­cism over its re­cent batch of mixed da­ta for ru­ca­parib. And Tesaro $TSRO is al­so hunt­ing an ap­proval of ni­ra­parib for a broad sec­ond-line main­te­nance group, with­out the use of a di­ag­nos­tic.

As­traZeneca CMO Sean Bo­hen not­ed:

Sean Bo­hen

“We are pleased with the ro­bust im­prove­ment in pro­gres­sion-free sur­vival demon­strat­ed by Lyn­parza in the SO­LO-2 tri­al. We will work with reg­u­la­to­ry au­thor­i­ties to make Lyn­parza tablets avail­able as quick­ly as pos­si­ble to pa­tients with ovar­i­an can­cer. We re­main com­mit­ted to in­ves­ti­gat­ing the full po­ten­tial of Lyn­parza, both as monother­a­py and in com­bi­na­tions, and to iden­ti­fy­ing all pa­tients who may ben­e­fit from this im­por­tant med­i­cine.”

Biotech Half­time Re­port: Af­ter a bumpy year, is biotech ready to re­bound?

The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.

RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.

How to col­lect and sub­mit RWD to win ap­proval for a new drug in­di­ca­tion: FDA spells it out in a long-await­ed guid­ance

Real-world data is messy. There can be differences in the standards used to collect different types of data, differences in terminologies and curation strategies, and even in the way data is exchanged.

While acknowledging this somewhat controlled chaos, the FDA is now explaining how biopharma companies can submit study data derived from real-world data (RWD) sources in applicable regulatory submissions, including new drug indications.

Endpoints Premium

Premium subscription required

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

David Lockhart, ReCode Therapeutics CEO

Pfiz­er throws its weight be­hind LNP play­er eye­ing mR­NA treat­ments for CF, PCD

David Lockhart did not see the meteoric rise of messenger RNA and lipid nanoparticles coming.

Thanks to the worldwide fight against Covid-19, mRNA — the genetic code that can be engineered to turn the body into a mini protein factory — and LNPs, those tiny bubbles of fat carrying those instructions, have found their way into hundreds of millions of people. Within the biotech world, pioneers like Alnylam and Intellia have demonstrated just how versatile LNPs can be as a delivery vehicle for anything from siRNA to CRISPR/Cas9.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,300+ biopharma pros reading Endpoints daily — and it's free.

No­vo CEO Lars Fruer­gaard Jør­gensen on R&D risk, the deal strat­e­gy and tar­gets for gen­der di­ver­si­ty

 

I kicked off our European R&D summit last week with a conversation involving Novo Nordisk CEO Lars Fruergaard Jørgensen. Novo is aiming to launch a new era of obesity management with a new approval for semaglutide. And Jørgensen had a lot to say about what comes next in R&D, how they manage risk and gender diversity targets at the trendsetting European pharma giant.

John Carroll: I’m here with Lars Jørgensen, the CEO of Novo Nordisk. Lars, it’s been a really interesting year so far with Novo Nordisk, right? You’ve projected a new era of growing sales. You’ve been able to expand on the GLP-1 franchise that was already well established in diabetes now going into obesity. And I think a tremendous number of people are really interested in how that’s working out. You have forecast a growing amount of sales. We don’t know specifically how that might play out. I know a lot of the analysts have different ideas, how those numbers might play out, but that we are in fact embarking on a new era for Novo Nordisk in terms of what the company’s capable of doing and what it’s able to do and what it wants to do. And I wanted to start off by asking you about obesity in particular. Semaglutide has been approved in the United States for obesity. It’s an area of R&D that’s been very troubled for decades. There have been weight loss drugs that have come along. They’ve attracted a lot of attention, but they haven’t actually ever gained traction in the market. My first question is what’s different this time about obesity? What is different about this drug and why do you expect it to work now whereas previous drugs haven’t?

Endpoints Premium

Premium subscription required

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

Pascal Soriot, AstraZeneca CEO (via Getty images)

UP­DAT­ED: FDA slaps As­traZeneca's MCL-1 can­cer drug with a hold af­ter safe­ty is­sue — 2 years af­ter Am­gen axed a trou­bled ri­val

There are new questions being posed about a class of cancer drugs in the wake of the second FDA-enforced clinical hold in the field.

Two years after the FDA hit Amgen with a clinical hold on its MCL-1 inhibitor AMG 397 following signs of cardiac toxicity, AstraZeneca says that regulators hit them with a hold on their rival therapy of the same class.

The pharma giant noted on clinicaltrials.gov that its Phase I/II study for the MCL-1 drug AZD5991 “has been put on hold to allow further evaluation of safety related information.”

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,300+ biopharma pros reading Endpoints daily — and it's free.

Sur­geons suc­cess­ful­ly at­tach pig kid­ney to a hu­man for the first time, us­ing tech from Unit­ed's Re­vivi­cor

In a first, researchers reportedly successfully transplanted a pig kidney into a human without triggering an immediate immune response this week. And the technology came from the biotech United Therapeutics.

Surgeons spent three days attaching the kidney to the patient’s blood vessels, but when all was said and done, the kidney appeared to be functioning normally in early testing, Reuters and the New York Times were among those to report. The kidney came from a genetically altered pig developed through United’s Revivicor unit.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 120,300+ biopharma pros reading Endpoints daily — and it's free.

Leen Kawas (L) has resigned as CEO of Athira and will be replaced by COO Mark Litton

Ex­clu­sive: Athi­ra CEO Leen Kawas re­signs af­ter in­ves­ti­ga­tion finds she ma­nip­u­lat­ed da­ta

Leen Kawas, CEO and founder of the Alzheimer’s upstart Athira Pharma, has resigned after an internal investigation found she altered images in her doctoral thesis and four other papers that were foundational to establishing the company.

Mark Litton, the company’s COO since June 2019 and a longtime biotech executive, has been named full-time CEO. Kawas, meanwhile, will no longer have ties to the company except for owning a few hundred thousand shares.

Endpoints Premium

Premium subscription required

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

Sen. Richard Durbin (D-IL, foreground) and Sen. Richard Blumenthal (D-CT) (Patrick Semansky/AP Images)

Sen­a­tors back FDA's plan to re­quire manda­to­ry pre­scriber ed­u­ca­tion for opi­oids

Three Senate Democrats are backing an FDA plan to require mandatory prescriber education for opioids as overdose deaths have risen sharply over the past decade, with almost 97,000 American opioid-related overdose deaths in the past year alone.

While acknowledging a decline in overall opioid analgesic dispensing in recent years, the FDA said it’s reconsidering the need for mandatory prescriber training through a REMS given the current situation with overdoses, and is seeking input on the aspects of the opioid crisis that mandatory training could potentially mitigate.

Bris­tol My­ers pledges to sell its Ac­celeron shares as ac­tivist in­vestors cir­cle Mer­ck­'s $11.5B buy­out — re­port

Just as Avoro Capital’s campaign to derail Merck’s proposed $11.5 billion buyout of Acceleron gains steam, Bristol Myers Squibb is leaning in with some hefty counterweight.

The pharma giant is planning to tender its Acceleron shares, Bloomberg reported, which add up to a sizable 11.5% stake. Based on the offer price, the sale would net Bristol Myers around $1.3 billion.

To complete its deal, Merck needs a majority of shareholders to agree to sell their shares.