FDA ush­ers Mer­ck­'s star can­cer drug Keytru­da to­ward an­oth­er key check­point

Mer­ck counts 22 ap­proved in­di­ca­tions for Keytru­da across 14 dif­fer­ent can­cer types. It is now be­ing ush­ered to­ward one more.

The PD-1 block­buster has been grant­ed pri­or­i­ty re­view for an­oth­er set of blad­der can­cer pa­tients: those with high-risk non-mus­cle in­va­sive blad­der can­cer (NIM­BC) who haven’t un­der­gone cys­tec­tomies and are re­sis­tant to the stan­dard treat­ment. The bi­o­log­ics li­cense ap­pli­ca­tion will be dis­cussed at the FDA on­col­o­gy drug meet­ing on De­cem­ber 17, Mer­ck said, and has a PDU­FA date for next month, Jan­u­ary 2020.

The ex­pe­dit­ed re­view is based on KEYNOTE-057, a sin­gle-arm Phase II study that found 40 out of 102 pa­tients had a com­plete re­sponse at three months. Of those, 29 (72.5%) re­mained tu­mor-free through the last check-up at 14 months. Da­ta were not pre­sent­ed on par­tial re­spons­es.

The news comes two months af­ter the hype around Roche’s self-vaunt­ed Phase III da­ta on Tecen­triq in blad­der can­cer was bat­ted down by the com­pa­ny’s own in­ves­ti­ga­tors.

For once, though, Mer­ck might not find it­self with the most eye-catch­ing can­cer drug ap­proach­ing ap­proval. Last week, Fer­ring spun out a biotech built around a gene ther­a­py that us­es an ade­n­ovirus to de­liv­er the can­cer-sup­press­ing gene in­ter­fer­on al­fa-2b in­to blad­der walls. Fer­Gene, as the new com­pa­ny is known, hasn’t an­nounced a PDU­FA date, but the drug al­so has pri­or­i­ty re­view and the biotech has $570 mil­lion in back­ing.

Keytru­da first gained ap­proval in a blad­der can­cer, ad­vanced urothe­lial car­ci­no­ma, in 2017. That in­di­ca­tion was al­most re­ject­ed by UK health au­thor­i­ty NICE, though, who saw it as po­ten­tial­ly too cost­ly for an end-of-life treat­ment but ul­ti­mate­ly okayed the drug in 2018.

Blad­der can­cer has long been treat­ed by an old­er form of im­munother­a­py: Bacil­lus Cal­mette-Guérin, a bac­te­r­i­al strain com­mon­ly used as a tu­ber­cu­lo­sis vac­cine, and which ap­pears to trig­ger an im­mune re­sponse in the blad­der that can af­fect tu­mors. NIM­BC pa­tients rep­re­sent 75% of the an­nu­al 80,000 new blad­der can­cer cas­es in the US, ac­cord­ing to com­pa­ny-cit­ed es­ti­mates.

Un­lock­ing ESG strate­gies for growth with Gilead Sci­ences

RBC Capital Markets explores what is material in ESG for biopharma companies with the ESG leads at Gilead Sciences. Gilead has long focused on sustainability but recognized a more robust framework was needed. Based on a materiality assessment, Gilead’s ESG strategy today focuses first on drug access and pricing, while also addressing D&I and climate change. Find out why Gilead’s board is “acutely aware” of the contribution that ESG makes to firm’s overall success.

Con­sor­tium of 5 drug reg­u­la­tors plot path to in­crease har­mo­niza­tion through 2024

A group of drug regulators from Australia, Canada, Singapore, Switzerland and the UK on Tuesday unveiled their strategic plans for the next three years, laying out how they’ll work together on reviewing new drugs to reduce duplication across borders.

While understanding that the biopharma industry is truly global, the group, known collectively as the Access Consortium, seeks to better align their respective regulatory and policy approaches for pharmaceuticals, with an aim to facilitate faster access to high quality, safe and effective health products.

On the hunt for the next Mod­er­na, in­vestors have pumped 'plat­form plays' with cash. Can any­thing slow the run­away train?

It didn’t take an expert to see that mRNA platforms could be huge.

Julie Sunderland partnered with both Moderna and BioNTech about a decade ago while she was running program-related investments for the Bill & Melinda Gates Foundation — and even then the potential for their platforms was obvious despite some well-founded concerns about whether the next-gen tech would ever cross the finish line.

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Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

Mer­ck­'s Keytru­da blazes a path in first-line cer­vi­cal can­cer, mak­ing good on drug­mak­er's push for ear­li­er pa­tients

In the years since I/O wonder drug Keytruda’s initial approval, Merck has struck an aggressive clinical trial program, which is now firmly focused on earlier lines of therapy. The drugmaker has scored some success there so far, and now it’s earned one of its biggest wins yet.

Keytruda plus chemotherapy with or without background Avastin significantly extended patients’ lives over those dosed with a placebo control in first-line patients with persistent, recurrent or metastatic cervical cancer, according to top-line data from the Phase III KEYNOTE-826 study revealed Tuesday.

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Neu­rona Ther­a­peu­tics is dash­ing to the clin­ic with its cell ther­a­py for epilep­sy — but first, an­oth­er ven­ture round

Six years ago, a band of neuroscientists from the University of California, San Francisco combined decades of research and jumped into the hunt for an off-the-shelf cell therapy. Now, that team is sprinting toward the clinic with a treatment for epilepsy — but first, it’s making a pit stop at the venture well.

Neurona Therapeutics unveiled a $41.5 million round on Tuesday morning, bringing the San Francisco-based biotech’s total raise to $135 million. The cash will be used to advance the company’s pipeline, including an upcoming Phase I/IIa for its lead candidate, NRTX-1001, in chronic focal epilepsy.

End­points News is now 5 years old. Here's how you can sup­port us for the next phase of growth

Endpoints News turned five years old over the weekend. I wanted to mark the happy occasion by extending our deepest gratitude to Endpoints’ premium subscribers while outlining several other ways to support us as we go broader and get bigger this year and beyond.

Same as any business, we’ve got to create value and get paid for delivering it. So if you depend on Endpoints to stay abreast on biopharma developments, we depend on you too.

Emma Walmsley, GlaxoSmithKline CEO (Credit: Fang Zhe/Xinhua/Alamy Live News)

Ac­tivist in­vestor El­liott in talks with oth­er Glax­o­SmithK­line in­vestors about re­plac­ing Em­ma Walm­s­ley, spin­ning off vac­cine busi­ness — re­port

As Emma Walmsley reveals details this Wednesday about the upcoming split of GlaxoSmithKline’s pharma and consumer units, some tough questions may be coming her way.

Elliott Management, the activist investor that’s previously threatened an attack on GSK (but eventually backed off), is floating more radical changes like replacing the CEO, further breaking up the company and spinning out the vaccine unit, or reviewing the focus on cancer drugs, the Financial Times reported.

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Fred Upton and Diana DeGette

New DARPA-like NIH agency preps for re­al­i­ty as E&C un­veils bi­par­ti­san Cures 2.0 draft bill

House Energy & Commerce leaders Fred Upton (R-MI) and Diana DeGette (D-CO) on Tuesday released new draft legislation with wide-ranging implications for public health, the FDA, NIH, and that would create a new, $6.5 billion federal advanced research agency under NIH, with an aim to cure cancer, Alzheimer’s and other difficult diseases.

Similar to DARPA, the new NIH division to be known as ARPA-H, would be run by a small group of program managers with more latitude to pursue high-risk, high-reward projects that other government agencies would likely shy away from.

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Sen. Ron Wyden (D-OR) with reporters in the Senate Subway (Graeme Sloan/Sipa via AP Images)

Top Wyden pri­or­i­ty for drug price re­forms: Medicare ne­go­ti­a­tions

As the Biden administration tries to wrangle the details of its infrastructure bill, Senate Finance Committee Chair Ron Wyden (D-OR) took a concrete step forward on drug pricing reforms on Tuesday and unveiled five principles for such reforms, including providing Medicare with the ability to negotiate prices.

“Allowing the Secretary of HHS to negotiate the price Medicare will pay creates a much needed mechanism to achieve fairer prices when the market has failed to do so,” Wyden wrote.