Glax­o­SmithK­line sets its sights on a quick leap in­to the big PD-1/L1 game — will any­one no­tice?

Some­what lost in the news last fall that Glax­o­SmithK­line was buy­ing Tesaro and leap­ing in­to the com­mer­cial end of the chal­leng­ing PARP mar­ket was a PD-1 check­point in­hibitor called TSR-042 that was be­ing point­ed to a quick fil­ing for en­dome­tri­al can­cer. On Tues­day, the GSK sub­sidiary spot­light­ed a promis­ing set of Phase I/II da­ta from their GAR­NET study, and the fil­ing is on track for lat­er this year as the phar­ma gi­ant looks to make its own en­try in­to an in­creas­ing­ly crowd­ed field.

Hal Bar­ron

The snap­shot for the new­ly dubbed dostar­limab: Over­all re­sponse rates in the full pop­u­la­tion of 125 women with a com­mon form of gy­ne­co­log­i­cal can­cer — then bro­ken in­to mi­crosatel­lite in­sta­bil­i­ty-high (MSI-H) and mi­crosatel­lite sta­ble (MSS) pa­tients — were 30%, 49%, and 20%, re­spec­tive­ly. “Dis­ease con­trol rate in the full pop­u­la­tion, MSI-H pop­u­la­tion, and MSS pop­u­la­tion was 53%, 63% and 47%, re­spec­tive­ly.”

It’s a small, ear­ly study, but the ma­jors in the field have been giv­en the green light for less.

In on­col­o­gy, any op­por­tu­ni­ty to use a new drug to help pa­tients is gen­er­al­ly avid­ly wel­comed. And GSK’s re­lease notes that there’s on­ly one ap­proved drug for the same set­ting in en­dome­tri­al can­cer, giv­ing them at least a leg up as ri­vals like Mer­ck fol­low up with their own check­point com­bo ap­proach­es.

It’s easy, though, to over­look an­oth­er quick en­try on the PD-1/L1 front. There are six ap­proved in the US, two that reg­is­ter mega block­buster sta­tus, a new ar­rival from Re­gen­eron sup­port­ed by a re­search chief known to bring a lit­tle fire and brim­stone to his lead­ing drug can­di­dates, and sev­er­al al­so rans, with Baven­cio from Pfiz­er/Mer­ck KGaA — which is rais­ing eye­brows af­ter a long string of clin­i­cal duds. And then there are the mul­ti­tude of new drugs com­ing up from be­hind, and from mul­ti­ple con­ti­nents.

Ax­el Hoos

GSK’s chal­lenge will be to grab at­ten­tion as a play­er, with Hal Bar­ron lead­ing the charge and Ax­el Hoos play­ing the lead role in can­cer. The phar­ma gi­ant is promis­ing to trans­form it­self in­to a heavy­weight in on­col­o­gy, af­ter es­sen­tial­ly miss­ing out on the can­cer rev­o­lu­tion that has shak­en the in­dus­try for the past 5 years. And a PD-1 back­bone drug can play a big part.

What’s in­ter­est­ing, though, is how lit­tle at­ten­tion they’re get­ting for their work. As­traZeneca and Mer­ck rule the PARP roost with Lyn­parza, grow­ing stronger at seem­ing­ly every turn. And Mer­ck’s Keytru­da is clear­ly the dom­i­nant drug in the PD-1/L1 crowd.

Play­ing in the back of this busy field won’t be easy. But no one is count­ing Bar­ron out.

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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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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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.

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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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.

UP­DAT­ED: Gilead keeps push­ing trove of Trodelvy da­ta as it seeks to be­come new stan­dard of care in TNBC

Gilead is continuing to churn out results for its newly approved drug Trodelvy, and #ESMO21 is the latest stop on the data train.

The biopharma put out new quality of life data in second-line patients with metastatic triple-negative breast cancer, saying that a sub-analysis from their Phase III study showed significant and clinically meaningful improvements in health-related quality of life over standard of care.

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.