Im­munomedics spells out PFS ben­e­fit of Trodelvy in mTNBC, hunt­ing a full OK just weeks af­ter ac­cel­er­at­ed ap­proval

By the time the FDA fi­nal­ly grant­ed an ac­cel­er­at­ed OK for Im­munomedics’ Trodelvy, we al­ready got a very strong hint that their con­fir­ma­to­ry Phase III study in metasta­t­ic triple-neg­a­tive breast can­cer was a suc­cess.

That’s be­cause the in­de­pen­dent da­ta safe­ty mon­i­tor­ing com­mit­tee rec­om­mend­ed that the tri­al be stopped ear­ly. But just what point­ed them to the con­clu­sion was still un­clear.

Be­hzad Ag­haz­adeh

“We do not know the to­tal­i­ty of their de­ci­sion oth­er than it’s pret­ty ev­i­dent that the pri­ma­ry end­point was met; oth­er­wise they could not re­quest to halt the study,” Be­hzad Ag­haz­adeh, the ex­ec­u­tive chair­man, told End­points News at the time.

Three months lat­er, Im­munomedics has de­tailed the re­sults from AS­CENT, in­clud­ing pro­gres­sion-free sur­vival and over­all sur­vival da­ta that the prin­ci­pal in­ves­ti­ga­tor said “set a new bench­mark” in mTNBC.

PFS was the pri­ma­ry end­point, and Trodelvy — an an­ti­body-drug con­ju­gate known as sac­i­tuzum­ab govite­can — kept the can­cer at bay (and pa­tients from dy­ing) for a me­di­an of 5.6 months, com­pared to 1.7 months on chemother­a­py (p<0.0001). The haz­ard ra­tio reg­is­tered at 0.41.

Shares $IM­MU rose 6.67% to $40.04.

Im­munomedics stopped short of spelling out the OS win, but not­ed that and oth­er key sec­ondary end­points such as ob­jec­tive re­sponse rate were met.

Aditya Bar­dia

“Im­por­tant­ly, the AS­CENT topline da­ta al­so val­i­date the man­age­able safe­ty pro­file of sac­i­tuzum­ab govite­can, ren­der­ing it a good part­ner can­di­date for com­bi­na­tion with oth­er ther­a­pies, in­clud­ing im­munother­a­py,” Aditya Bar­dia, the prin­ci­pal in­ves­ti­ga­tor and di­rec­tor of pre­ci­sion med­i­cine at Mass Gen­er­al’s Cen­ter for Breast Can­cer, said.

Trodelvy was ap­proved, with a black box warn­ing for se­vere neu­trope­nia and se­vere di­ar­rhea, as a third-line treat­ment for mTNBC, a tough-to-treat can­cer as­so­ci­at­ed with poor prog­no­sis. The new da­ta are ex­pect­ed to sup­port a full OK.

“It is grat­i­fy­ing to see the fi­nal con­fir­ma­to­ry re­sults of Trodelvy in a ran­dom­ized study sup­port­ing the pre­vi­ous­ly re­port­ed Phase 2 da­ta that formed the ba­sis of the ac­cel­er­at­ed ap­proval of Trodelvy,” Ag­haz­adeh, who has been run­ning the show since Michael Pehl left the helm ear­ly 2019 in the wake of an FDA re­jec­tion, said in a state­ment.

No­var­tis On­col­o­gy vet and Ipsen alum Harout Se­mer­jian came on board briefly as CEO in April, on­ly to de­part less than two months lat­er as the pan­dem­ic cre­at­ed in­sur­mount­able chal­lenges for mov­ing his fam­i­ly from Lon­don.

The hic­cup hasn’t dent­ed Cowen an­a­lyst Phil Nadeau’s high ex­pec­ta­tions of the ther­a­py, which his con­sul­tants said will be rapid­ly adopt­ed as the stan­dard in re­lapsed or re­frac­to­ry mTNBC, bring­ing in $1 bil­lion in world­wide rev­enue by 2025 (Ever­est Med­i­cines is han­dling the de­vel­op­ment and com­mer­cial­iza­tion in Chi­na). Ac­cord­ing to Nadeau, the num­bers hit the “up­per end of ex­pec­ta­tions.”

“In­vestors an­tic­i­pat­ed that Trodelvy would pro­duce a me­di­an PFS of 5-5.5 months con­sis­tent with its Ph. I/II, but our sense is that most an­tic­i­pat­ed a me­di­an PFS for chemother­a­py of 2.5-3 months,” he wrote.

And that’s not tak­ing in­to ac­count its po­ten­tial in ER+/HER2- metasta­t­ic breast can­cer or urothe­lial car­ci­no­ma, which now seems even more like­ly giv­en the pos­i­tive AS­CENT da­ta.

“In­vestors un­der­es­ti­mate the sales po­ten­tial of Trodelvy,” he wrote in a re­cent note. “Trodelvy’s da­ta sug­gest it is a sim­i­lar im­prove­ment over the stan­dard of care in r/r ER+/HER2- mBC as it is in mTNBC, and there are ap­prox. 3-4x as many women with r/r ER+/HER2- mBC. This mar­ket is a $3-4B op­por­tu­ni­ty for Trodelvy, not yet ful­ly re­flect­ed in es­ti­mates or in IM­MU’s val­u­a­tion, de­spite po­ten­tial­ly piv­otal da­ta an­tic­i­pat­ed around YE.”

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Mathai Mammen (Rob Tannenbaum, Endpoints News at BIO 2018)

Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck five years ago, where the soft-spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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Samantha Du, Zai Lab CEO

Any­one still look­ing for a CD47? Zai Lab shelves PhI pro­gram af­ter re­view­ing 'com­pet­i­tive land­scape'

Over the past few years, the promise of blocking CD47 — a “don’t eat me” signal co-opted by cancer cells — has sent drugmakers big and small into a frenzy. But one biotech is now bowing out.

Zai Lab is deprioritizing ZL-1201, its CD47 inhibitor, scrapping plans for a Phase II trial. It will now “pursue out-licensing opportunities,” the company said in its Q2 update. The decision was based on a review of the competitive landscape, it added, without going into further details.

Illustration: Kim Ryu for Endpoints News

Why non-opi­oid pain drugs keep fail­ing — and what's next for the field

In 1938, Rita Levi-Montalcini was forced to move her lab into her bedroom in Turin, as Mussolini’s facist government expelled Jewish people from studying or working in schools in Italy. Levi-Montalcini, then just a few years out of medical school and using sewing needles as scalpels in her makeshift lab, would soon discover nerve growth factor, or NGF, in chicken embryos.

Her discoveries formed the basis of our understanding of the peripheral nervous system and how cells talk to each other, and Levi-Montalcini went on to win the Nobel Prize in 1986. Much later, NGF was hailed as a promising target for new pain therapies, with some analysts quoting an $11 billion market. However, the latest anti-NGF candidate, Pfizer and Eli Lilly’s tanezumab, was rejected by the FDA last year because of a side effect that dissolved bone in some of its patients.

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Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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HHS Secretary Xavier Becerra (Patrick Semansky/AP Images)

US weighs new route of ad­min­is­tra­tion for mon­key­pox vac­cine as cas­es climb — re­port

Less than a week after HHS Secretary Xavier Becerra declared monkeypox a national health emergency, reports have emerged that the US plans to extend its vaccine supply by opting for a different route of administration.

Officials are expected to call for intradermal injection of Bavarian Nordic’s Jynneos vaccine — the only shot approved specifically for monkeypox in the US — as opposed to subcutaneous injection, unnamed sources told both the New York Times and Washington Post on Tuesday.

'Messy at best': Is the US re­peat­ing the same Covid mis­steps with mon­key­pox mes­sag­ing?

When Kyle Planck first suspected he might have monkeypox in late June, he went to the CDC website and found six photos of different types of lesions. And that was about it for general public information.

Planck, who is a sixth-year PhD pharmacology researcher at Weill Cornell, kept looking though and found a separate part of the CDC website meant for healthcare professionals. There he found a medical slide deck with more pictures, professional journal articles and more details about symptoms and diagnosis.

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US to stop sup­ply­ing Lil­ly's mAb for Covid-19 this month as com­mer­cial mar­ket awaits

Federal officials said yesterday that shipments of Eli Lilly’s bebtelovimab — one of the final two remaining mAb treatments for Covid-19 — would halt later this month, setting up a commercial market where the government no longer pays for the doses and hospitals and other clinics will have to purchase supplies.

According to ASPR, the arm of HHS that ships Covid-19 drugs, states have ordered 627,536 bebtelovimab courses, and 383,515 courses have been administered as of July 31. The US has paid Lilly a total of about $1.27 billion for all of the courses so far, amounting to about $2,100 per course to start and then receiving a discounted $1,833 ASP for the later part of the deal. According to the Wall Street Journal, Lilly’s list price for bebtelovimab is $2,100 per dose.

Stanley Erck, Novavax CEO (Photographer: Kevin Dietsch/UPI/Bloomberg via Getty Images)

No­vavax shares shred­ded as Covid vac­cine sales fall more than 90% in Q2

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room: