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.”

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

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Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Charlie Fuchs, Roche and Genentech global head of product development for oncology and hematology (Yale Cancer Center)

Yale can­cer spe­cial­ist Char­lie Fuchs tapped as new glob­al de­vel­op­ment chief for Roche/Genen­tech

Roche and their big sub Genentech have just recruited a top cancer specialist at Yale to head up global product development in oncology and hematology.

I just got word that the pharma giant, which leads one of the most active cancer research operations in the world, recruited Charlie Fuchs, director of the Yale Cancer Center and physician-in-chief of Smilow Cancer Hospital. He’ll join the global operation March 1 and will be based in South San Francisco, where Genentech is based.

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Jonathan Weissman (MIT)

Can a new CRISPR tech­nique un­lock the se­crets of how can­cer spreads?

Jonathan Weissman’s team watched the cancer cells spread across the doomed mouse. Engineered with a bioluminescent enzyme, they appeared in scans first as a small navy blue diamond lodged near the heart; a week later, as a triangle splayed across the mouse’s upper body, with streaks of green and two distinct bright red hubs of activity. By day 54, the mouse resembled a lava lamp.

The images would have been familiar to any cancer biologist, but they didn’t actually tell you much about what was going on: why the cancer was metastasizing or which cells were responsible. For that, Weissman’s team had designed a new tool. Inside the original navy blue diamond, they had engineered the microbiological equivalent of an airplane’s black box — a “molecular recorder” that, after the mouse’s death, could allow them to extract the cells and wind back intimate footage of a single cancer’s ascent.

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Glax­o­SmithK­line scraps a LAG3 study, mark­ing an­oth­er fail­ure for the pipeline af­ter a crit­i­cal set­back

Another gap has appeared in GlaxoSmithKline’s pipeline.

Friday morning the Australian biotech Immutep put out word that Hal Barron’s R&D group at GSK had decided to scrap a Phase II proof-of-concept study in ulcerative colitis for their anti-LAG3 therapy GSK2831781. According to the biotech, the program didn’t survive an interim review.

The trial was stopped by GSK based on the assessment of clinical data as part of a planned interim analysis conducted in consultation with the trial’s Data Review Committee. GSK is conducting further reporting, assessment and analyses of the efficacy and safety data and evaluating the biology to determine next steps for the GSK2831781 development program.

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Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.