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.”

Jan Hatzius (Photographer: Christopher Goodney/Bloomberg via Getty Images)

When will it end? Gold­man econ­o­mist gives late-stage vac­cines a good shot at tar­get­ing 'large shares' of the US by mid-2021 — but the down­side is daunt­ing

It took decades for hepatitis B research to deliver a slate of late-stage candidates capable of reining the disease in.

With Covid-19, the same timeline has devoured all of 5 months. And the outcome will influence the lives of billions of people and a multitrillion-dollar world economy.

Count the economists at Goldman Sachs as optimistic that at least one of these leading vaccines will stay on this furiously accelerated pace and get over the regulatory goal line before the end of this year, with a shot at several more near-term OKs. That in turn should lead to the production of billions of doses of vaccines that can create herd immunity in the US by the middle of next year, with Europe following a few months later.

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J&J gets a fresh OK for es­ke­t­a­mine, but is it re­al­ly the game-chang­er for de­pres­sion Trump keeps tweet­ing about?

Backed by an enthusiastic set of tweets from President Trump and a landmark OK for depression, J&J scooped up a new approval from the FDA for Spravato today. But this latest advance will likely bring fresh scrutiny to a drug that’s spurred some serious questions about the data, as well as the price.

First, the approval.

Regulators stamped their OK on the use of Spravato — developed as esketamine, a nasal spray version of the party drug Special K or ketamine — for patients suffering from major depressive disorder with acute suicidal ideation or behavior.

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UP­DAT­ED: No­vavax her­alds the lat­est pos­i­tive snap­shot of ear­ly-stage Covid-19 vac­cine -- so why did its stock briefly crater?

High-flying Novavax $NVAX became the latest of the Covid-19 vaccine players to stake out a positive set of biomarker data from its early-stage look at its vaccine in humans.

Their adjuvanted Covid-19 vaccine was “well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera,” the company noted. According to the biotech:

All subjects developed anti-spike IgG antibodies after a single dose of vaccine, many of them also developing wild-type virus neutralizing antibody responses, and after Dose 2, 100% of participants developed wild-type virus neutralizing antibody responses. Both anti-spike IgG and viral neutralization responses compared favorably to responses from patients with clinically significant COVID‑19 disease. Importantly, the IgG antibody response was highly correlated with neutralization titers, demonstrating that a significant proportion of antibodies were functional.

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FDA hands Mor­phoSys and In­cyte a quick OK on their po­ten­tial block­buster CAR-T al­ter­na­tive

Nearly three years after okaying the CAR-Ts Yescarta and Kymriah, the FDA has approved a new CD19 therapy.

MorphoSys’ Monjuvi, or tafasitamab-cxix, was cleared Friday for use in refractory diffuse large B-cell lymphoma (DBLCL). The approval sets up both MorphoSys and their commercial partner Incyte to compete with Gilead and Novartis in the ultra-competitive indication, where similar trial results and far easier delivery could allow them to cut a fair share of the market.

So Covid-19 leader BioN­Tech has a can­cer vac­cine in de­vel­op­ment? Yes, and Re­gen­eron just jumped in for the PhII com­bo study

Before the coronavirus global emergency stole the R&D show in biopharma, the leaders in the race to develop new mRNA therapies had a big interest in determining if their tech could be used to create an effective cancer vaccine after all the first-gen tries had failed to impress. So perhaps it’s not surprising that an early cut of the data at frontrunner BioNTech went largely unnoticed.

Unless you were at Regeneron.

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No­var­tis says Kym­ri­ah reach­es pri­ma­ry end­point in new PhII, al­though num­bers still to come

The race to develop CAR-T therapies has died down since Novartis’ Kymriah and Gilead’s Yescarta first crossed the finish line, though Tecartus also recently received approval. But the companies continue to expand their drugs’ applications, with Novartis preparing to conclude a new Phase II.

Interim data announced by the Swiss pharma show that Kymriah met its primary endpoint of complete response rate in treating patients with relapsed or refractory follicular lymphoma, the second-most common form of non-Hodgkin lymphoma. Based on preliminary trial findings, Kymriah had received RMAT designation from the FDA in April for r/r follicular lymphoma.

Ab­b­Vie shrugs off $134M cash deals, quit­ting a neu­ro R&D pact with Voy­ager Ther­a­peu­tics on vec­tor­ized an­ti­body treat­ments

It’s the end of the road for Voyager Therapeutics’ collaboration with AbbVie on tau and alpha-synuclein vectorized antibody development.

In two deals spanning the last two years, AbbVie dropped more than $134 million upfront for Voyager’s preclinical R&D of vectorized antibody treatments for diseases like Alzheimer’s and Parkinson’s. But Voyager says AbbVie is walking away now, without offering an explanation for why.

Mer­ck scoops up a PhII J&J dis­card in a bar­gain-base­ment deal. And this time they’re shoot­ing at NASH

When J&J turned to South Korea’s Hanmi for a GLP-1/glucagon dual receptor agonist obesity drug, the pharma giant paid $105 million in a cash upfront for the licensing rights and plotted a big clinical trial program to test it. A year ago, like a few of Hanmi’s big partners, J&J reviewed their trial data and walked away, handing it back.

Now Merck is stepping up to grab it for their NASH pipeline — and they got it a lot cheaper than J&J.

Igor Splawski (CureVac)

Cure­Vac nabs a top No­var­tis sci­en­tist for CSO slot as mR­NA vac­cines seize the spot­light

One of the key players in the race to develop a new mRNA vaccine to fight Covid-19 has reshuffled the top spots in the executive suite. And they’re bringing in a Novartis vet out of Harvard to spearhead their work on mRNA.

CureVac, which just filed for an IPO that’s still taking shape, has formally handed Franz-Werner Haas the CEO title, after giving it to him on an interim basis. And the still rather stealthy German biotech largely owned by billionaire Dietmar Hopp has recruited Igor Splawski as its chief scientific officer.

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