FDA OKs Mer­ck’s Keytru­da for Hodgkin lym­phoma, a first in blood can­cer

Mer­ck has racked up an­oth­er FDA ap­proval for Keytru­da, this time for clas­si­cal Hodgkin lym­phoma, mark­ing the PD-1 block­er’s first green-light for use in liq­uid tu­mors.

Reg­u­la­tors hand­ed out the OK for pa­tients who had al­ready failed at least three ther­a­pies.

The agency based this ap­proval on the da­ta Mer­ck col­lect­ed in 210 pa­tients from the KEYNOTE-087 tri­al, which demon­strat­ed an over­all re­sponse rate of 69%, with a com­plete re­mis­sion rate — no de­tectable can­cer — of 22% and a par­tial re­mis­sion rate of 47%.

The ap­proval was a first for Mer­ck, but it comes 9 months af­ter Op­di­vo was ap­proved in cHL. Sun­Trust sug­gests that Mer­ck’s la­bel could have im­pli­ca­tions for Seat­tle Ge­net­ics’ Ad­cetris. They wrote:

We be­lieve Keytru­da’s broad la­bel pro­vides a new al­ter­na­tive to clas­si­cal Hodgkin lym­phoma pa­tients who have pri­ma­ry re­frac­to­ry dis­ease, an in­di­ca­tion for which Ad­cetris is not yet ap­proved. For ad­vanced cHL, we be­lieve pri­ma­ry re­frac­to­ry dis­ease oc­curs in up to 20% of pa­tients on stan­dard front-line reg­i­mens (AB­VD, al­ter­na­tive AB­VD/MOPP) and in ~10% of pa­tients on more in­ten­sive reg­i­mens,

Roger M. Perl­mut­ter, Mer­ck

Mer­ck had been rel­e­gat­ed to the num­ber two po­si­tion in the big check­point mar­ket, trail­ing well be­hind adop­tion of Bris­tol-My­ers Squibb’s Op­di­vo. Then Op­di­vo ex­pe­ri­enced a se­ries of set­back late last year that turned the mar­ket up­side down, fa­vor­ing Keytru­da and forc­ing Bris­tol-My­ers to shake up its re­search or­ga­ni­za­tion.

Said Dr. Roger M. Perl­mut­ter, pres­i­dent, Mer­ck Re­search Lab­o­ra­to­ries:

To­day’s ap­proval – the first for Keytru­da in a hema­to­log­ic ma­lig­nan­cy – re­in­forces the hope that im­munother­a­py will prove use­ful in a wide va­ri­ety of can­cers.

“For the pa­tients with clas­si­cal Hodgkin lym­phoma who are not cured with ex­ist­ing treat­ments, there are lim­it­ed op­tions, and treat­ing their dis­ease be­comes more chal­leng­ing,” added Dr. Craig Moskowitz, clin­i­cal di­rec­tor, di­vi­sion of hema­to­log­ic on­col­o­gy, Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter. “This ap­proval is an im­por­tant step for­ward in treat­ing these pa­tients, who are gen­er­al­ly young and have a par­tic­u­lar­ly poor prog­no­sis, and gives us the op­por­tu­ni­ty to help pa­tients in their fight against this dev­as­tat­ing dis­ease.”

5AM Ven­tures: Fu­el­ing the Next Gen­er­a­tion of In­no­va­tors

By RBC Capital Markets
With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures

Key Points

Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities.
Unlocking the potential of the microbiome could be the missing link to better disease diagnosis.
Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies.
Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom.

Hal Barron, GSK via YouTube

What does $29B buy you in Big Phar­ma? In Glax­o­SmithK­line’s case, a whole lot of un­com­fort­able ques­tions about the pipeline

Talk about your bad timing.

A little over a week ago, GSK R&D chief Hal Barron marked his third anniversary at the research helm by taking a turn at the virtual podium during JP Morgan to make the case that he and his team had built a valuable late-stage pipeline capable of churning out more than 10 blockbusters in the next 5 years.

And then, just days later, one of the cancer drugs he bet big on as a top prospect — bintrafusp, partnered with Merck KGaA — failed its first pivotal test in non-small cell lung cancer.

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Eli Lil­ly's an­ti­body cuts risk of Covid-19 by up to 80% among the most vul­ner­a­ble — but will it have a place next to vac­cines?

Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus.

But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear.

Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance.

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Janet Woodcock (AP Images)

End­points poll: Janet Wood­cock takes the (in­ter­im) helm at the FDA. And a large ma­jor­i­ty of our read­ers want her to stay there

It’s official: Janet Woodcock is now the acting chief of the FDA.

And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed.

To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come.

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What’s next for End­points — and how to sup­port our in­de­pen­dent bio­phar­ma news mis­sion

The firehose of biopharma news is gushing these days.

That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style.

Charlie Fuchs, Roche and Genentech global head of product development for oncology and hematology (Yale Cancer Center)

Yale can­cer spe­cial­ist Char­lie Fuchs tapped as new glob­al de­vel­op­ment chief for Roche/Genen­tech

Roche and their big sub Genentech have just recruited a top cancer specialist at Yale to head up global product development in oncology and hematology.

I just got word that the pharma giant, which leads one of the most active cancer research operations in the world, recruited Charlie Fuchs, director of the Yale Cancer Center and physician-in-chief of Smilow Cancer Hospital. He’ll join the global operation March 1 and will be based in South San Francisco, where Genentech is based.

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Jonathan Weissman (MIT)

Can a new CRISPR tech­nique un­lock the se­crets of how can­cer spreads?

Jonathan Weissman’s team watched the cancer cells spread across the doomed mouse. Engineered with a bioluminescent enzyme, they appeared in scans first as a small navy blue diamond lodged near the heart; a week later, as a triangle splayed across the mouse’s upper body, with streaks of green and two distinct bright red hubs of activity. By day 54, the mouse resembled a lava lamp.

The images would have been familiar to any cancer biologist, but they didn’t actually tell you much about what was going on: why the cancer was metastasizing or which cells were responsible. For that, Weissman’s team had designed a new tool. Inside the original navy blue diamond, they had engineered the microbiological equivalent of an airplane’s black box — a “molecular recorder” that, after the mouse’s death, could allow them to extract the cells and wind back intimate footage of a single cancer’s ascent.

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Michelle McMurry-Heath, BIO CEO (BIO via YouTube)

BIO looks to re­struc­ture, lay­ing off staff amid chal­lenge to the trade org's nor­mal face-to-face style

The biopharma industry, on the whole, had a red-letter year in 2020 amid Covid-19, with fundraising at an all-time high and major players speeding vaccines ahead to approval. But for BIO, the industry’s leading trade organization, the pandemic has prompted a reconsideration of the game plan.

BIO will pivot to digital as the Covid-19 pandemic continues to rage, making “some staff reductions” as it looks to bring its roughly 37,000 in-person meetings each year to the web, the organization said Thursday.

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Janet Woodcock and Joshua Sharfstein (AP, Images)

Poll: Should Joshua Sharf­stein or Janet Wood­cock lead the FDA from here?

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.