Clo­vis shares tank af­ter in­vestors size up the dis­ap­point­ing da­ta on ru­ca­parib

Clo­vis On­col­o­gy’s shares got ham­mered this morn­ing af­ter the biotech re­vealed some mixed re­sults for its PARP in­hibitor ru­ca­parib.

The biotech re­port­ed a 54% ob­jec­tive re­sponse rate for the drug for BR­CA-mu­tat­ed ovar­i­an can­cer, with nine (9%) com­plete re­spon­ders and 48 (45%) par­tial re­spon­ders. Bor­ing down in­to the da­ta, in­ves­ti­ga­tors al­so re­port­ed ze­ro re­sponse among the 7% of the pa­tients who were plat­inum-re­frac­to­ry, a 25% re­sponse rate for plat­inum-re­sis­tant pa­tients and 66% for plat­inum-sen­si­tive re­spons­es.

The me­di­an pro­gres­sion-free sur­vival time in the sin­gle-arm study was ten months.

Clo­vis faces tough com­pe­ti­tion in this field. And in­vestors didn’t like the way the da­ta was break­ing down com­pared to ri­vals like Tesaro’s ni­ra­parib, which was put through a ran­dom­ized study with a con­trol arm.

Clo­vis’s stock, which has been zoom­ing up in an­tic­i­pa­tion of the da­ta, quick­ly plunged 28% Fri­day morn­ing. By the end of the day Clo­vis saw the loss­es cut to a still painful 18%.

Some an­a­lysts quick­ly not­ed that the drug doesn’t ap­pear to look good in com­par­i­son to As­traZeneca’s Lyn­parza, ap­proved in late 2014 with its own set of mixed da­ta that drew a re­buke from an FDA pan­el. As­traZeneca’s da­ta in­clud­ed this note on plat­inum-re­sis­tant pa­tients:

Kauf­man et al eval­u­at­ed ola­parib 400 mg bid in a co­hort of pa­tients with germline BR­CA mu­ta­tions and ad­vanced sol­id tu­mors in­clud­ing 193 pa­tients with plat­inum-re­sis­tant ovar­i­an can­cer. In this sub­set of pa­tients, a tu­mor re­sponse rate of 31.1% was ob­served with an ad­di­tion­al 40% of pa­tients achiev­ing sta­ble dis­ease for at least 8 weeks

Tesaro re­port­ed ear­li­er that the ni­ra­parib arm hit the pri­ma­ry end­point of their study with a me­di­an PFS of 12.9 months com­pared to 3.8 months for the con­trol arm. Among germline BR­CA mu­ta­tion pa­tients, the me­di­an PFS for pa­tients treat­ed with ni­ra­parib was 21.0 months, com­pared to 5.5 months for con­trol. And it has more da­ta com­ing up at ES­MO this week­end.

The painful re­cep­tion for the Boul­der, CO-based biotech’s da­ta to­day un­der­score some se­ri­ous is­sues at Clo­vis On­col­o­gy. The com­pa­ny was forced to re­state its da­ta sub­mit­ted for an ap­proval of rocile­tinib, prompt­ing an em­bar­rass­ing and dev­as­tat­ing drop in the num­ber of re­spons­es that the biotech had claimed for their drug. An FDA pan­el sub­se­quent­ly re­ject­ed the drug, prompt­ing Clo­vis to re­struc­ture and lay off staffers.

Now all of its wag­ons are cir­cled around ru­ca­parib, a PARP that will go head to head with As­traZeneca’s Lyn­parza as well as quite pos­si­bly ni­ra­parib. And now Pfiz­er has ta­la­zoparib, an­oth­er PARP in­hibitor now in a piv­otal tri­al that’s shown con­sid­er­able promise. Ru­ca­parib is ahead of Tesaro’s drug on the reg­u­la­to­ry front, with a PDU­FA date of Feb­ru­ary 23.

Clo­vis can’t af­ford an­oth­er fail­ure. But some an­a­lysts had been up­beat about ru­ca­parib af­ter the FDA waved a pan­el re­view for the drug, which might in­di­cate their sup­port.

(Cor­rec­tion: This sto­ry was cor­rect­ed to take out a ref­er­ence to the 9 peo­ple who died in the study. The Clo­vis drug was not linked with any of their deaths, ac­cord­ing to the biotech.)

Health­care Dis­par­i­ties and Sick­le Cell Dis­ease

In the complicated U.S. healthcare system, navigating a serious illness such as cancer or heart disease can be remarkably challenging for patients and caregivers. When that illness is classified as a rare disease, those challenges can become even more acute. And when that rare disease occurs in a population that experiences health disparities, such as people with sickle cell disease (SCD) who are primarily Black and Latino, challenges can become almost insurmountable.

David Meek, new Mirati CEO (Marlene Awaad/Bloomberg via Getty Images)

Fresh off Fer­Gene's melt­down, David Meek takes over at Mi­rati with lead KRAS drug rac­ing to an ap­proval

In the insular world of biotech, a spectacular failure can sometimes stay on any executive’s record for a long time. But for David Meek, the man at the helm of FerGene’s recent implosion, two questionable exits made way for what could be an excellent rebound.

Meek, most recently FerGene’s CEO and a past head at Ipsen, has become CEO at Mirati Therapeutics, taking the reins from founding CEO Charles Baum, who will step over into the role of president and head of R&D, according to a release.

Who are the women su­per­charg­ing bio­phar­ma R&D? Nom­i­nate them for this year's spe­cial re­port

The biotech industry has faced repeated calls to diversify its workforce — and in the last year, those calls got a lot louder. Though women account for just under half of all biotech employees around the world, they occupy very few places in C-suites, and even fewer make it to the helm.

Some companies are listening, according to a recent BIO survey which showed that this year’s companies were 2.5 times more likely to have a diversity and inclusion program compared to last year’s sample. But we still have a long way to go. Women represent just 31% of biotech executives, BIO reported. And those numbers are even more stark for women of color.

Jacob Van Naarden (Eli Lilly)

Ex­clu­sives: Eli Lil­ly out to crash the megablock­buster PD-(L)1 par­ty with 'dis­rup­tive' pric­ing; re­veals can­cer biotech buy­out

It’s taken 7 years, but Eli Lilly is promising to finally start hammering the small and affluent PD-(L)1 club with a “disruptive” pricing strategy for their checkpoint therapy allied with China’s Innovent.

Lilly in-licensed global rights to sintilimab a year ago, building on the China alliance they have with Innovent. That cost the pharma giant $200 million in cash upfront, which they plan to capitalize on now with a long-awaited plan to bust up the high-price market in lung cancer and other cancers that have created a market worth tens of billions of dollars.

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When ef­fi­ca­cy is bor­der­line: FDA needs to get more con­sis­tent on close-call drug ap­provals, agency-fund­ed re­search finds

In the exceedingly rare instances in which clinical efficacy is the only barrier to a new drug’s approval, new FDA-funded research from FDA and Stanford found that the agency does not have a consistent standard for defining “substantial evidence” when flexible criteria are used for an approval.

The research comes as the FDA is at a crossroads with its expedited-review pathways. The accelerated approval pathway is under fire as the agency recently signed off on a controversial new Alzheimer’s drug, with little precedent to explain its decision. Meanwhile, top officials like Rick Pazdur have called for a major push to simplify and clarify all of the various expedited pathways, which have grown to be must-haves for sponsors of nearly every newly approved drug.

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Ted White, Verrica CEO

Ver­ri­ca hits an­oth­er bump in the road with CMO re­lat­ed let­ter from FDA

The FDA has rejected Verrica’s new drug application for VP-102 again, with the company pinning the CRL on problems at a CMO that it was partnered with, the company announced Monday.

The FDA didn’t raise issues that directly relate to the manufacturing of VP-102, the company said, but raised “general quality issues” at the CMO’s facility. There were also no clinical concerns, it said, or need to collect more data.

Volker Wagner (L) and Jeff Legos

As Bay­er, No­var­tis stack up their ra­dio­phar­ma­ceu­ti­cal da­ta at #ES­MO21, a key de­bate takes shape

Ten years ago, a small Norwegian biotech by the name of Algeta showed up at ESMO — then the European Multidisciplinary Cancer Conference 2011 — and declared that its Bayer-partnered targeted radionuclide therapy, radium-223 chloride, boosted the overall survival of castration-resistant prostate cancer patients with symptomatic bone metastases.

In a Phase III study dubbed ALSYMPCA, patients who were treated with radium-223 chloride lived a median of 14 months compared to 11.2 months. The FDA would stamp an approval on it based on those data two years later, after Bayer snapped up Algeta and christened the drug Xofigo.

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Mi­rati tri­umphs again in KRAS-mu­tat­ed lung can­cer with a close­ly watched FDA fil­ing now in the cards

After a busy weekend at #ESMO21, which included a big readout for its KRAS drug adagrasib in colon cancer, Mirati Therapeutics is ready to keep the pressure on competitor Amgen with lung cancer data that will undergird an upcoming filing.

In topline results from a Phase II cohort of its KRYSTAL-1 study, adagrasib posted a response rate of 43% in second-line-or-later patients with metastatic non-small cell lung cancer containing a KRAS-G12C mutation, Mirati said Monday.

Jay Bradner (Jeff Rumans for Endpoints News)

Div­ing deep­er in­to in­her­it­ed reti­nal dis­or­ders, No­var­tis gob­bles up an­oth­er bite-sized op­to­ge­net­ics biotech

Right about a year ago, a Novartis team led by Jay Bradner and Cynthia Grosskreutz at NIBR swooped in to scoop up a Cambridge, MA-based opthalmology gene therapy company called Vedere. Their focus was on a specific market niche: inherited retinal dystrophies that include a wide range of genetic retinal disorders marked by the loss of photoreceptor cells and progressive vision loss.

But that was just the first deal that whet their appetite.

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