GSK flash­es pos­i­tive da­ta for Tesaro drug that could be­come 7th ap­proved PD-(L)1

A dark horse as­set from Glax­o­SmithK­line’s $5.1 bil­lion buy­out of Tesaro is out with its first batch of da­ta in over a year — promis­ing da­ta that could line up the British drug­mak­er for the 7th FDA ap­proved PD-1 drug, al­though it’s not clear when.

Hal Bar­ron GSK

When GSK pur­chased the Waltham-based can­cer biotech in De­cem­ber of 2018, con­ver­sa­tion fo­cused right­ly on Ze­ju­la, the al­ready-ap­proved PARP in­hibitor, and whether the new ex­ec­u­tive crew of Hal Bar­ron and Em­ma Walm­s­ley were right in their as­ser­tion that the drug could both ri­val As­traZeneca’s Lyn­parza and have util­i­ty in more than just ovar­i­an can­cer. But Tesaro al­so brought a cou­ple of oth­er clin­i­cal stage as­sets. Chief among them: a PD-1 in­hibitor called dostar­limab.

Em­ma Walm­s­ley

GSK first re­leased da­ta for dostar­limab four months af­ter the buy­out. To­day they’re back with an­oth­er set that, while not over­whelm­ing, helps con­firm some of the promise of the ini­tial round. In 71 pa­tients with re­cur­rent or ad­vanced mis­match re­pair-de­fi­cient (dMMR) en­dome­tri­al can­cer that pro­gressed on or af­ter chemother­a­py, the drug led to a 42% over­all re­sponse rate and a 58% dis­ease con­trol rate. That broke down in­to 13% com­plete re­sponse rate and a 30% par­tial re­sponse rate.

The da­ta were for one co­hort of the larg­er Phase I/II GAR­NET tri­al that first read out last year. Four oth­ers are al­so un­der­way and still en­rolling for pa­tients with dif­fer­ent types of the en­dome­tri­al can­cer, which GSK cites as the most com­mon gy­nae­co­log­ic ma­lig­nan­cy.

When GSK re­leased the first da­ta in March 2019, the drug­mak­er said they would sub­mit a BLA for sec­ond-line en­dome­tri­al can­cer to the FDA by the end of the year, and they qui­et­ly dis­closed that they had done so in their 2019 full-year re­port. Al­though there’s still no word on when that ap­pli­ca­tion was sub­mit­ted, GSK said in the re­port that an­tic­i­pat­ed ap­proval is ex­pect­ed in the sec­ond half of 2020.

As with their PARP in­hibitor Ze­ju­la, dostar­limab would en­ter a crowd­ed mar­ket — what has be­come, in fact, one of the most crowd­ed mar­kets in on­col­o­gy, with six dif­fer­ent PD-1/L1 ther­a­pies on the mar­ket and a clear gi­ant in the field in Mer­ck’s Keytru­da. Few, though, are ap­proved for en­dome­tri­al can­cers. An ap­proval could help some of those pa­tients, and al­so go a ways to­ward jus­ti­fy­ing Tesaro’s cost and sig­nal­ing GSK’s re­turn to on­col­o­gy.

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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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 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.

Amgen VP of R&D David Reese

Am­gen rolls out da­ta for KRAS in­hibitor com­bo study in col­orec­tal can­cer, hop­ing to move on from ug­ly ear­ly re­sults

With the first win for its KRAS inhibitor sotorasib in hand, Amgen is pushing ahead with an aggressive clinical plan to capitalize on its first-to-market standing. The drugmaker thinks combinations — in-house or otherwise — could offer a path forward, and one early readout from that strategy is bearing fruit.

A combination of Amgen’s sotorasib and its EGFR inhibitor Vectibix posted an overall response rate of 27% in 26 patients with advanced colorectal cancer (CRC) with the KRAS-G12C mutation, according to data from the larger Phase Ib/II CODEBREAK 101 study set to present at this weekend’s virtual ESMO Congress.

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Gri­fols drops $1B on Ger­man hold­ing com­pa­ny in con­tin­ued plas­ma push

One Spanish biotech is beefing up its plasma therapy operations, and on Friday, it announced that it’s doing so in a billion-dollar deal.

Grifols is now the largest shareholder of Biotest, a company valued at more than $1.8 billion. By teaming up, the two will try to increase the number of plasma therapies available and increase patient access around the world, Grifols said in a press release.

The company did so by acquiring holding company Tiancheng Pharmaceutical, the Germany-based owner of nearly 90% of Biotest shares, for nearly $1.27 billion. Grifols now owns nearly 90% of Biotest voting rights and almost 45% of the total share capital of Biotest.

Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)

Eu­ro­pean study finds that Gilead­'s Covid-19 an­tivi­ral remde­sivir shows no clin­i­cal ben­e­fit

Gilead’s remdesivir — or Veklury, as it’s marketed in the US — raked in around $2.8 billion last year as the only FDA-approved antiviral to treat Covid-19. But new data from a European study suggest the drug, which has been given to about half of hospitalized Covid patients in the country, has no actual benefit.

The open-label DisCoVeRy trial enrolled Covid-19 patients across 48 sites in Europe to test a handful of treatments, including remdesivir, lopinavir–ritonavir, lopinavir–ritonavir and interferon beta-1a, and hydroxychloroquine. To participate, patients had to show symptoms for seven days and require oxygen support. A total of 429 patients were randomized to receive remdesivir plus standard of care, while 428 were assigned to standard of care alone.

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Covid-19 roundup: FDA re­veals boost­er ad­comm ques­tion; Eli Lil­ly's an­ti­body cock­tail cleared for pre­ven­tion

The FDA released briefing documents this week from the agency and Pfizer each outlining their arguments for today’s Covid-19 booster shot adcomm, but one thing conspicuously missing was the question on which panel members would be voting. But late Thursday night, regulators published that question.

Adcomm members will be asked whether or not the safety and efficacy data from Pfizer/BioNTech’s original Phase III study “support approval” of a booster shot at least six months after the second dose in individuals older than 16. The question notably excludes the real-world data from Israel and other analyses that Pfizer and the Biden administration had said would be a centerpiece of their arguments for boosters.

A Pfiz­er part­ner wel­comes ex-ADC Ther­a­peu­tics CMO Jay Fein­gold to the team; Amid tough sled­ding, Im­muno­vant choos­es Eli Lil­ly alum as CFO

→ Last week we told you about the CMO revolving door at ADC Therapeutics, as Joseph Camardo replaced the departing Jay Feingold. The next opportunity for Feingold in the CMO slot has opened up at antibody-drug conjugate and mAb developer Pyxis Oncology, which has added several new execs and scientific advisory board members in recent months, including ex-Immunovant CFO Pamela Yanchik Connealy. Before his tenure at ADC, Feingold was Daiichi Sankyo’s VP of US medical affairs and chairman of the Global Medical Affairs Oversight Committee. Within weeks in March, Pyxis struck a licensing deal with Pfizer for two of its ADCs and raked in $152 million from a Series B round.

Ali Tehrani, Zymeworks CEO

Zymeworks squares up with Her­ceptin af­ter HER2 bis­pe­cif­ic aces mid-stage test in esophageal can­cer

Roche’s Herceptin has long stood as standard of care across multiple advanced cancers, but a suite of next-gen players are looking to beat the aging giant at its own game. In HER2-expressing esophageal cancer, BeiGene partner Zymeworks thinks its bispecific antibody could have the juice to get it done.

Zymeworks’ bispecific antibody zanidatamab, combined with one of two chemotherapy regimens, posted an overall response rate of 75% in patients with advanced gastroesophageal adenocarcinoma (GEA) who had not previously received a HER2-targeted cancer therapy, the Vancouver-based biotech said Thursday.