Ab­b­Vie shares tank on Ro­va-T flop, sud­den re­treat from ac­cel­er­at­ed ap­proval pitch

Ab­b­Vie’s stock $AB­BV is get­ting ham­mered this morn­ing af­ter its $10 bil­lion Ro­va-T pro­gram post­ed poor mid-stage re­sults for third-line small cell lung can­cer, forc­ing the com­pa­ny to scut­tle any plans to seek an ac­cel­er­at­ed ap­proval for the close­ly-watched drug af­ter talks with skep­ti­cal reg­u­la­tors.

Af­ter fan­ning hopes — amid con­sid­er­able skep­ti­cism in some cir­cles — with its pro­jec­tions of a mega-block­buster fu­ture for Ro­va-T, in­ves­ti­ga­tors out­lined a 16% ob­jec­tive re­sponse rate and me­di­an over­all sur­vival of 5.6 months for the drug.

Shares cratered on the terse re­lease, free falling 13% and wip­ing more than $20 bil­lion off its mar­ket cap, which start­ed the day at $178 bil­lion.

Michael Sev­eri­no

The mag­ni­tude of the ORR for the DLL3-high group was dis­mal, leav­ing the fu­ture of the drug in doubt. And by im­pli­ca­tion, some an­a­lysts are won­der­ing just how bad the da­ta are for the full group, ex­pect­ing the fi­nal read out to be even worse.

I queried Ab­b­Vie about the break­down, and a spokesper­son con­firmed the re­sults were for the sub­group.

The da­ta re­port­ed to­day were in pa­tients ex­press­ing high DLL3 com­pris­ing 74 per­cent of the over­all study pop­u­la­tion in TRIN­I­TY.

By fo­cus­ing on DLL3-ex­press­ing can­cers, the mar­ket was ex­pect­ing an ORR in the 40% range. Chemo com­bos are in the 20% area, an­a­lysts note, and IO com­bos are al­so demon­strat­ing ef­fi­ca­cy. So with an IRC as­sess­ment at 16%, Ab­b­Vie is well be­hind the 8 ball, with the FDA chill­ing talk of an ac­cel­er­at­ed ap­proval de­spite the fact that there are no ap­proved op­tions.

Se­vere ad­verse events were record­ed for throm­bo­cy­tope­nia (11%), pho­to­sen­si­tiv­i­ty re­ac­tion (7%) and pleur­al ef­fu­sion (5%).

Ab­b­Vie paid $5.8 bil­lion in cash for this drug, promis­ing up to $4 bil­lion more in mile­stones to ac­quire the lit­tle-known biotech uni­corn Stem­cen­trx. And with mon­ey like that on the ta­ble, ex­pec­ta­tions were run­ning high, fu­el­ing fore­casts that the phar­ma com­pa­ny could get past the even­tu­al loss of patent pro­tec­tion on Hu­mi­ra in style. Ab­b­Vie it­self pro­ject­ed peak sales at $5 bil­lion a year.

To­day, Ab­b­Vie is feel­ing the lash of dis­ap­point­ed an­a­lysts. Here’s Ge­of­frey Porges:

On­col­o­gy is the key growth busi­ness seg­ment for Ab­b­Vie af­ter the loss of ex­clu­siv­i­ty for Hu­mi­ra in 2023, and to­day’s re­sults and reg­u­la­to­ry de­ci­sion call in­to ques­tion the vi­a­bil­i­ty of the com­pa­ny’s cur­rent sol­id tu­mor strat­e­gy.

Com­bined with Bris­tol-My­ers’ Op­di­vo and Yer­voy, Ab­b­Vie was bet­ting that it had a win­ner in small cell lung can­cer, though its first cut of the ear­ly da­ta last year failed to im­press any­one out­side of the com­pa­ny. The drug drops a cy­to­tox­ic bomb right on DLL3-ex­press­ing can­cer cells com­mon in SCLC.

“We con­tin­ue to be­lieve Ro­va-T has po­ten­tial for pa­tients with small cell lung can­cer and oth­er DLL3-ex­press­ing can­cers,” said Mike Sev­eri­no, ex­ec­u­tive vice pres­i­dent of re­search and de­vel­op­ment and chief sci­en­tif­ic of­fi­cer, Ab­b­Vie. “Al­though the re­sults from the study were not what we hoped for, we look for­ward to re­ceiv­ing da­ta from the on­go­ing Phase 3 stud­ies in the first- and sec­ond-line set­tings and re­main com­mit­ted to de­vel­op­ing Ro­va-T for the treat­ment of pa­tients with small cell lung can­cer.”

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

FDA chief Stephen Hahn on Capitol Hill earlier this week (Getty Images)

As FDA buck­les un­der the strain of a pan­dem­ic work­load, Trump again ac­cus­es the agency of a po­lit­i­cal hit job

Peter Marks appeared before a virtual SVB Leerink audience yesterday and said that his staff at FDA’s CBER is on the verge of working around the clock. Manufacturing inspections, policy work and sponsor communications have all been pushed down the to-do list so that they can be responsive to Covid-related interactions. And the agency’s objective right now? “To save as many lives as we can,” Marks said, likening the mortality on the current outbreak as equivalent to “a nuclear bomb on a small city.”

Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

Play-by-play of Gilead­'s $21B Im­munomedics buy­out de­tails a fren­zied push — and mints a new biotech bil­lion­aire

Immunomedics had not really been looking for a buyout when the year began. Excited by its BLA for Trodelvy, submitted to the FDA in late 2019, executive chairman Behzad Aghazadeh started off looking for potential licensing deals and zeroed in on four potential partners, including Gilead, following January’s JP Morgan Healthcare Conference in San Francisco. Such talks advanced throughout the year, with discussions advancing to the second round in mid-August.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,500+ biopharma pros reading Endpoints daily — and it's free.

The win­dow is wide open as four more biotechs join the go-go IPO class of 2020

It’s another day of hauling cash in the biopharma world as four more IPOs priced Friday and a fifth filed its initial paperwork.

The biggest offering comes from PMV Pharma, an oncology biotech focusing on p53 mutations, which raised $211.8 million after pricing shares at $18 apiece. Prelude Therapeutics, developing PRMT5 inhibitors for rare cancers, was next with a $158 million raise, pricing shares at $19 each. Graybug Vision raised $90 million after pricing at $16 per share for its wet AMD candidates, and breast cancer biotech Greenwich Lifesciences brought up the rear with a small, $7 million raise after pricing shares at $5.75.

J&J of­fers PhI/IIa da­ta show­ing its sin­gle-dose vac­cine can stir up suf­fi­cient im­mune re­sponse

Days after J&J dosed the first participants of its Phase III ENSEMBLE trial, the pharma giant has detailed the early-stage data that gave them confidence in a single-dose regimen.

Testing two dose levels either as a single dose or in a two-dose schedule spaced by 56 days in, the scientists from Janssen, the J&J subsidiary developing its vaccine, reported that the low dose induced a similar immune response as the high dose. The interim Phase I/IIa results were posted in a preprint on medRxiv.

President Donald Trump reacts after signing an executive order following his remarks on his healthcare policies yesterday in Charlotte, North Carolina (Getty Images)

Op-ed: Will phar­ma re­al­ly pay for Trump’s lat­est law­less promise to 33 mil­lion Medicare ben­e­fi­cia­ries? Not like­ly

Sitting atop the executive branch, President Donald Trump is the ultimate authority at the FDA. He can fast track any vaccine to approval himself. If it came to that, of course.

What he can’t do is unilaterally order the legislative branch to loosen the Treasury’s coffers for $6.6 billion. Nor can he command pharmaceutical companies to pay for $200 vouchers sent to 33 million Medicare beneficiaries for prescription drugs before the election.

Pal­la­dio bags $20 mil­lion Se­ries B to top­ple a prob­lem­at­ic kid­ney dis­ease drug

Palladio Biosciences just took one step further in its quest to topple Otsuka’s Samsca with its own — it hopes safer — autosomal dominant polycystic kidney disease (ADPKD) drug.

The Pennsylvania-based biotech announced a $20 million Series B on Friday, which will fund a 10-person Phase III trial of its vasopressin V2 receptor agonist, lixivaptan. CEO Alex Martin expects to read out data in the first half of next year, then launch straight into a larger pivotal Phase III study with about 1,200 participants.

New York governor Andrew Cuomo (AP Images)

An­drew Cuo­mo says New York will un­der­take its own vac­cine re­view process, and wouldn’t rec­om­mend trust­ing the fed­er­al gov­ern­ment

The concerns keep mounting over President Donald Trump’s politicization of the FDA and other federal agencies guiding the development of a safe and effective vaccine. And today, the telegenic New York governor Andrew Cuomo appeared to introduce even more politics into the matter — latest in an ongoing series of incidents that have cast the proudly independent FDA in starkly political terms.

During his daily press conference Cuomo said that the state will review any coronavirus vaccines approved by the federal government, citing a lack of trust in the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.

PhII Alzheimer's fail­ure deals new blow to Roche, AC Im­mune — but the tau hy­poth­e­sis is far from dead

The leading anti-tau antibody has failed its first Phase II testing, casting a shadow on a popular target (just trailing amyloid beta) for Alzheimer’s disease.

Roche and AC Immune are quick to acknowledge disappointment in the topline readout, which suggested that semorinemab did not reduce cognitive decline among patients with early Alzheimer’s disease, who are either just starting to have symptoms or have mild manifestations.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 90,500+ biopharma pros reading Endpoints daily — and it's free.