Tesaro v Myr­i­ad: Ni­ra­parib part­ners squared off in court as Tesaro tried to quash a con­trary press re­lease

When Tesaro re­leased their da­ta on the PARP drug ni­ra­parib a few days ago, the biotech was de­ter­mined to make a case for a broad ap­proval, with­out any need for a di­ag­nos­tic test to dis­tin­guish pa­tients with a par­tic­u­lar bio­mark­er for ovar­i­an can­cer.

Not every­body, of course, bought in to that ar­gu­ment, with some crit­ics say­ing that the da­ta were iffy at best. One key ob­jec­tion, though, came from Myr­i­ad Ge­net­ics, which de­vel­oped the com­pan­ion di­ag­nos­tic test Tesaro used in Phase III and now wants to see put in­to use. And Tesaro wound up tak­ing them to court in a failed at­tempt to shut it down.

Livid over a pro­posed re­lease from Myr­i­ad which made an ar­gu­ment against Tesaro’s case, the biotech filed for an in­junc­tion in US Dis­trict Court in New York on Oc­to­ber 7, claim­ing that the Myr­i­ad PR in­clud­ed “false and mis­lead­ing state­ments” about the da­ta. It ve­he­ment­ly ob­ject­ed to re­marks about the “over­all tox­i­c­i­ty pro­file” and quotes from some peo­ple who, they claimed, had nev­er seen the da­ta.

The judge, said Tesaro’s lawyers, should shut it down as a vi­o­la­tion of their part­ner­ship agree­ment.

Judge Richard Sul­li­van, though, didn’t buy in­to that ar­gu­ment, not­ing that Tesaro was al­ready plan­ning to pub­lish the da­ta, Myr­i­ad wasn’t breach­ing their agree­ment in any case, and Tesaro wasn’t go­ing to suf­fer ir­repara­ble harm.

Mo­tion de­nied. PR is­sued.

A spokesper­son for Tesaro, though, says they were al­so able to set­tle their dis­agree­ment over the re­lease.

“We had a dis­agree­ment with Myr­i­ad about mes­sag­ing in Myr­i­ad’s pro­posed ES­MO press re­lease, so we filed a com­plaint to stop it from be­ing is­sued un­til we could mu­tu­al­ly agree on the con­tent,” she said in an email to End­points News. “Once the con­tent was agreed up­on, the news re­lease was is­sued, and the suit was dropped.”

Tesaro is left in the same po­si­tion it was ear­li­er, work­ing to prove that the ef­fi­ca­cy da­ta for ni­ra­parib qual­i­fies for an ap­proval for use in pa­tients who are ei­ther HRD pos­i­tive or HRD neg­a­tive. But they’re al­so in a po­si­tion of be­ing op­posed by a part­ner who has a sol­id busi­ness case for ar­gu­ing that the drug should be re­served for pa­tients who would be most like­ly to ben­e­fit. And there are a num­ber of an­a­lysts who are sid­ing with Myr­i­ad on this one.

The ben­e­fit nar­rows pro­gres­sive­ly by that last step, and the 3.1-month pro­gres­sion sur­vival ben­e­fit for the HRD-neg­a­tive group in the Phase III — 6.9 months ver­sus 3.8 months — will get plen­ty of scruti­ny by reg­u­la­tors.

The ar­gu­ing now will move from the courts to the FDA, where the two col­lab­o­ra­tors can square off against each oth­er once again. The out­come will dic­tate just how much each com­pa­ny stands to make from this drug.

What Will it Take to Re­al­ize the Promise and Po­ten­tial of Im­mune Cell Ther­a­pies?

What does it take to get to the finish line with a new cancer therapy – fast? With approvals in place and hundreds of immune cell therapy candidates in the pipeline, the global industry is poised to create a fundamental shift in cancer treatments towards precision medicine. At the same time, unique challenges associated with cell and process complexity present manufacturing bottlenecks that delay speed to market and heighten cost of goods sold (COGS) — these hurdles must be overcome to make precision treatments an option for every cancer patient. This series of articles highlights some of the key manufacturing challenges associated with the production of cell-based cancer therapies as well as the solutions needed to transcend them. Automation, process knowledge, scalability, and assured supply of high-quality starting material and reagents are all critical to realizing the full potential of CAR-based therapies and sustaining the momentum achieved in recent years. The articles will highlight leading-edge technologies that incorporate these features to integrate across workflows, accelerate timelines and reduce COGS – along with how these approaches are enabling the biopharmaceutical industry to cross the finish line faster with new treatment options for patients in need.

The biggest ques­tions fac­ing gene ther­a­py, the XLMTM com­mu­ni­ty, and Astel­las af­ter fourth pa­tient death

After three patients died last year in an Astellas gene therapy trial, the company halted the study and began figuring out how to safely get the program back on track. They would, executives eventually explained, cut the dose by more than half and institute a battery of other measures to try to prevent the same thing from happening again.

Then tragically, Astellas announced this week that the first patient to receive the new regimen had died, just weeks after administration.

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Lat­est news: It’s a no on uni­ver­sal boost­ers; Pa­tient death stuns gene ther­a­py field; In­side Tril­li­um’s $2.3B turn­around; and more

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Next week is shaping up to be a busy one, as our editor-in-chief John Carroll and managing editor Kyle Blankenship lead back-to-back discussions with a great group of experts to discuss the weekend news and trends. John will be spending 30 minutes with Jake Van Naarden, the CEO of Lilly Oncology, and Kyle has a brilliant panel lined up: Harvard’s Cigall Kadoch, Susan Galbraith, the new head of cancer R&D at AstraZeneca, Roy Baynes at Merck, and James Christensen at Mirati. Don’t miss out on the action — sign up here.

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President Biden and Pfizer CEO Albert Bourla (Patrick Semansky/AP Images)

Chaot­ic ad­comm sees Pfiz­er/BioN­Tech boost­ers re­ject­ed for gen­er­al pop­u­la­tion, but rec­om­mend­ed for old­er and high-risk pop­u­la­tions

With just days before President Joe Biden’s Covid-19 booster rollout is set to go into effect, an FDA advisory committee appeared on the verge of not recommending boosters for anyone in the US before a last-minute change of wording laid the groundwork for older adults to have access to a third dose.

The FDA’s adcomm on Vaccines and Related Biological Products (VRBPAC) roundly rejected Pfizer/BioNTech booster shots for all individuals older than 16 by a 16-2 vote Friday afternoon. Soon after, however, the agency posed committee members a new question limiting booster use to the 65-and-older population and individuals at high risk of disease due to occupational exposure or comorbidities.

As­traZeneca, Dai­ichi Sanky­o's ADC En­her­tu blows away Roche's Kad­cy­la in sec­ond-line ad­vanced breast can­cer

AstraZeneca and Japanese drugmaker Daiichi Sankyo think they’ve struck gold with their next-gen ADC drug Enhertu, which has shown some striking data in late-stage breast cancer trials and early solid tumor tests. Getting into earlier patients is now the goal, starting with Enhertu’s complete walkover of a Roche drug in second-line breast cancer revealed Saturday.

Enhertu cut the risk of disease progression or death by a whopping 72% (p=<0.0001) compared with Roche’s ADC Kadcyla in second-line unresectable and/or metastatic HER2-positive breast cancer patients who had previously undergone treatment with a Herceptin-chemo combo, according to interim data from the Phase III DESTINY-Breast03 head-to-head study presented at this weekend’s #ESMO21.

Merck Research Laboratories CMO Roy Baynes

Mer­ck­'s Keytru­da un­corks full da­ta on lat­est ad­ju­vant win — this time in melanoma — adding bricks to ear­ly can­cer wall

In recent months, the battle for PD-(L)1 dominance has spilled over into early cancer with Merck’s Keytruda and Bristol Myers Squibb’s Opdivo all alone on the front lines. Keytruda now has another shell in its bandolier, and it could spell a quick approval.

Keytruda cut the risk of relapse or death by 35% over placebo (p=0.00658) in high-risk, stage 2 melanoma patients who had previously undergone surgery to remove their tumors, according to full data from the Phase III KEYNOTE-716 presented Saturday at #ESMO21.

Mer­ck flesh­es out Keytru­da win in first-line cer­vi­cal can­cer, adding more fire­pow­er to its ear­ly can­cer push

Merck has worked hard to bring its I/O blockbuster Keytruda into earlier and earlier lines of therapy, and now the wonder drug appears poised to make a quick entry into early advanced cervical cancer.

A combination of Keytruda and chemotherapy with or without Roche’s Avastin cut the risk of death by 33% over chemo with or without Avastin (p=<0.001) in first-line patients with persistent, recurrent or metastatic cervical cancer, according to full data from the Phase III KEYNOTE-826 study presented Saturday at #ESMO21.

EQRx chairman Alexis Borisy and CEO Melanie Nallichieri

EQRx, CStone un­furl full lung can­cer da­ta for PD-L1 drug in what the part­ners are call­ing a first

As a self-stylized drug pricing disruptor, EQRx has high hopes for its lead PD-(L)1 to offer proof of concept for the entire business model. After touting a win back in May, the biotech is back with full data in lung cancer that could back up an approval.

Patients dosed with EQRx and CStone Pharmaceuticals’ sugemalimab posted median progression-free survival of 9 months compared with 5.8 months for patients given placebo (p=0.0026), according to full data from the Phase III GEMSTONE-301 study in Stage III non-small cell lung cancer set to be presented at this weekend’s #ESMO21.

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As­traZeneca touts Imfinzi im­munother­a­py com­bos for lung can­cer in push to dri­ve PD-L1 drug up­take

Facing the big dogs in the PD-(L)1 space, AstraZeneca has taken its own contender Imfinzi into blockbuster territory in its four years on the market but sees even bigger things for the drug. Combinations could be the key, and early results from a mid-stage test are adding some fuel to that strategy.

Imfinzi combined with one of two investigational immunotherapies — a CD73 antibody dubbed oleclumab or an Innate’s anti-NGK2a named monalizumab — topped Imfinzi alone in terms of overall response and progression-free survival in patients with stage III non-small cell lung cancer whose tumors had not worsened during concurrent chemoradiation, according to interim data from the Phase II COAST trial set to be presented at #ESMO21.