Mer­ck scores new ad­vance on tu­mor-ag­nos­tic front as Keytru­da beat chemo-based reg­i­mens in a type of col­orec­tal can­cer

Back in 2017, be­fore the term “tu­mor ag­nos­tic” re­al­ly took hold among can­cer drug de­vel­op­ers, Mer­ck be­came the first to se­cure such an ap­proval for Keytru­da as a sec­ond-line treat­ment for pa­tients char­ac­ter­ized by a bio­mark­er — rather than where the can­cer start­ed in the body. Now it’s look­ing to break fresh ground with a new slate of da­ta sug­gest­ing the drug’s util­i­ty in the front­line set­ting for col­orec­tal can­cer.

To­day’s da­ta come from an in­ter­im analy­sis of KEYNOTE-177, which com­pared Keytru­da to a num­ber of chemother­a­py-based reg­i­mens of choice. Topline re­sults in­di­cate the PD-1 drug met one of the dual pri­ma­ry end­points: pro­gres­sion-free sur­vival. The oth­er, over­all sur­vival, is still be­ing stud­ied.

Roy Baynes

All 308 pa­tients in the Phase III tri­al have stage IV col­orec­tal car­ci­no­ma con­firmed to be ad­vanced mi­crosatel­lite in­sta­bil­i­ty-high (MSI-H) or mis­match re­pair de­fi­cient (dMMR). Mi­crosatel­lites are short, re­peat­ed se­quences of DNA. When they ap­pear in dif­fer­ent sizes as the germline DNA, it sig­nals a de­fect in the abil­i­ty to re­pair mis­takes that oc­cur when DNA is be­ing copied.

Around 10% to 15% of col­orec­tal can­cer pa­tients have tu­mors that fit the de­scrip­tion, Mer­ck not­ed.

Roy Baynes, CMO of Mer­ck Re­search Lab­o­ra­to­ries, em­pha­sized that the head-to-head da­ta rep­re­sent a his­toric feat for the PD-1: It’s the first time a sin­gle-agent ther­a­py achieved a sta­tis­ti­cal­ly sig­nif­i­cant im­prove­ment in PFS over chemo, “in­clud­ing the cur­rent stan­dard of care reg­i­men of mFOL­FOX6 plus be­va­cizum­ab, in pa­tients with MSI-H col­orec­tal can­cer,” he said.

Mizuho an­a­lyst Mara Gold­stein con­tin­ues to cheer Mer­ck on, not­ing that there’s a lack of avail­able ther­a­pies in col­orec­tal can­cer be­yond chemo plus Er­bitux or Avastin.

“This is the third tri­al thus far with a dual PFS/OS end­point that has reached PFS on in­ter­im and is con­tin­u­ing to an OS read­out, which we see as skew­ing fu­ture OS read­outs to the up­side through 2021,” she added.

The oth­er two are KEYNOTE-355 in first-line PD-L1 pos­i­tive triple-neg­a­tive breast can­cer and KEYNOTE-204 in re­lapsed/re­frac­to­ry clas­si­cal Hodgkin lym­phoma.

A PFS win, though, doesn’t guar­an­tee suc­cess on the OS front, as the painful set­back in KEYNOTE-604 (ex­ten­sive-stage small cell lung can­cer, or ES-SCLC) showed. How the FDA — which was demon­stra­bly up­beat when wav­ing through Keytru­da’s first MSI-H OK — will han­dle that kind of sit­u­a­tion re­mains to be seen.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

Gilead re­leas­es an­oth­er round of murky remde­sivir re­sults

A month after the NIH declared the first trial on remdesivir in Covid-19 a success, Gilead is out with new results on their antiviral. But although the study met one of its primary endpoints, the data are likely to only add to a growing debate over how effective the drug actually is.

In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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Ken Frazier, AP Images

Why Mer­ck wait­ed, and what they now bring to the Covid-19 fight

Nicholas Kartsonis had been running clinical infectious disease research at Merck for almost 2 years when, in mid-January, he got a new assignment: searching the pharma giant’s vast libraries for something that could treat the novel coronavirus.

The outbreak was barely two weeks old when Kartsonis and a few dozen others got to work, first in small teams and then in a larger task force that sucked in more and more parts of the sprawling company as Covid-19 infected more and more of the globe. By late February, the group began formally searching for vaccine and antiviral candidates to license. Still, while other companies jumped out to announce their programs and, eventually and sometimes controversially, early glimpses at human data, Merck remained silent. They made only a brief announcement about a data collection partnership in April and mentioned vaguely a vaccine and antiviral search in their April 28 earnings call.

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Mark Genovese (Stanford via Twitter)

Gilead woos fil­go­tinib clin­i­cal in­ves­ti­ga­tor from Stan­ford to lead the charge on NASH, in­flam­ma­to­ry dis­eases

With an FDA OK for the use of filgotinib in rheumatoid arthritis expected to drop any day now, Gilead has recruited a new leader from academia to lead its foray into inflammatory diseases.

Mark Genovese — a longtime Stanford professor and most recently the clinical chief in the division of immunology and rheumatology — was the principal investigator in FINCH 2, one of three studies that supported Gilead’s NDA filing. In his new role as SVP, inflammation, he will oversee the clinical development of the entire portfolio.

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Bris­tol My­ers Squib­b's just-launched MS drug Zeposia makes the cut in key ul­cer­a­tive col­i­tis tri­al

In March, Zeposia became the third oral S1P modulator to secure US approval for multiple sclerosis. Now, the drug has succeeded in a key ulcerative colitis study.

The immunomodulator, akin to others in its class, controls lymphocyte trafficking by limiting the white blood cells to the lymphatic system, in the lymph nodes, and thwarting their ability to jam up lymph nodes — precluding their ability to penetrate the bloodstream and the central nervous system.

Stephen Isaacs, Aduro president and CEO (Aduro)

Once a high fly­er, a stag­ger­ing Aduro is auc­tion­ing off most of the pipeline as CEO Stephen Isaacs hands off the shell to new own­ers

After a drumbeat of failure, setbacks and reorganizations over the last few years, Aduro CEO Stephen Isaacs is handing over his largely gutted-out shell of a public company to another biotech company and putting up some questionable assets in a going-out-of-business sale.

Isaacs —who forged a string of high-profile Big Pharma deals along the way — has wrapped a 13-year run at the biotech with one program for kidney disease going to the new owners at Chinook Therapeutics. A host of once-heralded assets like their STING agonist program partnered with Novartis (which dumped their work on ADU-S100 after looking over weak clinical results), the Lilly-allied cGAS-STING inhibitor program and the anti-CD27 program out-licensed to Merck will all be posted for auction under a strategic review process.

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Hill­house re­casts spot­light on Chi­na's biotech scene with $160M round for Shang­hai-based an­ti­body mak­er

Almost two years after first buying into Genor Biopharma’s pipeline of cancer and autoimmune therapies, Hillhouse Capital has led a $160 million cash injection to push the late-stage assets over the finish line while continuing to fund both internal R&D and dealmaking.

The Series B has landed right around the time Genor would have listed on the Hong Kong stock exchange, according to plans reported by Bloomberg late last year. Insiders had said that the company was looking to raise about $200 million.

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Novus Ther­a­peu­tics plunges deep in­to pen­ny stock ter­ri­to­ry af­ter failed ear tri­al

After a more than 15-year run, a California-based biotech is exploring options, including a sale, after its lead experimental therapy failed an exploratory mid-stage study in patients with middle ear infections characterized by a build-up of fluid behind the eardrum.

The company, initially called Tokai Pharmaceuticals but which subsequently changed its name to Novus Therapeutics in 2017, saw its shares more than halve on Monday after the drug — OP0201— did not pass muster as an adjunct therapy to oral antibiotics in infants and children aged 6 to 24 months with acute otitis media (OM).