FDA slaps a par­tial hold on one of As­traZeneca's cru­cial dur­val­um­ab pro­grams

Shares of As­traZeneca $AZN start­ed to slide this morn­ing as the phar­ma gi­ant con­firmed that the FDA has placed a par­tial clin­i­cal hold on a Phase III re­search pro­gram in­volv­ing its check­point in­hibitor dur­val­um­ab, halt­ing new en­roll­ment.

The par­tial hold was in­sti­tut­ed af­ter in­ves­ti­ga­tors tracked bleed­ing events in a Phase III com­bo study for dur­val­um­ab, its top in­ves­ti­ga­tion­al drug, with treme­li­mum­ab for head and neck can­cer. But the com­pa­ny cau­tions that all oth­er stud­ies are pro­ceed­ing as planned, not­ing that such bleed­ing events are not un­usu­al in head and neck can­cer.

That said, As­traZeneca can ill af­ford any de­lays in the de­vel­op­ment of dur­val­um­ab now. The com­pa­ny al­ready de­layed its de­vel­op­ment time­line for the check­point in­hibitor to al­low for com­bi­na­tion stud­ies, which As­traZeneca is count­ing on to make a splash with a late ar­rival in the field.

A set­back here will raise fresh ques­tions for As­traZeneca as it at­tempts to play catch-up to the mar­ket lead­ers in check­point in­hibitors. Dur­val­um­ab is now a dis­tant fourth — or fifth — in the mar­ket, like­ly to fol­low Roche’s $RHH­BY Tecen­triq and well be­hind Mer­ck ($MRK/Keytru­da) and Bris­tol-My­ers Squibb $BMY, which has racked up block­buster sales with Op­di­vo.

As­traZeneca’s shares are down 5%.

The news about the safe­ty is­sue has been per­co­lat­ing in­side As­traZeneca for more than a month.

In a fol­lowup to a query, As­traZeneca said that they took the first step in paus­ing en­roll­ment in mid-Sep­tem­ber, more than a month ago, then fol­lowed up with no­tices to reg­u­la­tors and in­ves­ti­ga­tors. Ac­cord­ing to a spokesper­son:

The FDA re­cent­ly con­firmed their agree­ment with our ac­tion and placed a par­tial clin­i­cal hold on re­cruit­ment of new pa­tients while we com­plete our analy­sis. We sent an up­date to Clin­i­cal­Tri­als.gov with­in the usu­al time­frames. Our analy­sis is now com­plete and has been sub­mit­ted to FDA and un­der their re­view; we hope to re­sume [en­roll­ment] as soon as pos­si­ble.

Here’s the full ini­tial state­ment sent to End­points News:

Fol­low­ing the re­cent up­date on clin­i­cal­tri­als.gov, As­traZeneca con­firms that the US FDA has placed a par­tial clin­i­cal hold on the en­roll­ment of new pa­tients with head and neck squa­mous cell car­ci­no­ma (HN­SCC) in clin­i­cal tri­als of dur­val­um­ab as monother­a­py and in com­bi­na­tion with treme­li­mum­ab or oth­er po­ten­tial med­i­cines. All tri­als are con­tin­u­ing with ex­ist­ing pa­tients.

The par­tial clin­i­cal hold on new pa­tient [en­roll­ment] re­lates on­ly to head and neck can­cer. Tri­als for dur­val­um­ab in dif­fer­ent can­cer types, as monother­a­py or in com­bi­na­tion with treme­li­mum­ab or oth­er po­ten­tial med­i­cines, are pro­gress­ing as planned, with piv­otal da­ta in lung can­cer an­tic­i­pat­ed in the first half of 2017.

The FDA’s de­ci­sion fol­lows vol­un­tary ac­tion by As­traZeneca to pause [en­roll­ment] of new HN­SCC pa­tients while a de­tailed analy­sis is con­duct­ed of ad­verse events re­lat­ed to bleed­ing that were ob­served as part of rou­tine safe­ty mon­i­tor­ing of the Phase III KESTREL and EA­GLE tri­als. Bleed­ing is a known com­pli­ca­tion in treat­ments of head and neck can­cers pri­mar­i­ly due to the na­ture of the un­der­ly­ing dis­ease, the prox­im­i­ty of tu­mours to ma­jor blood ves­sels and use of pri­or can­cer ther­a­pies, which may in­volve surgery and ra­di­a­tion.

As­traZeneca has sub­mit­ted its analy­sis of the ob­served bleed­ing events to the FDA for re­view and is work­ing close­ly with the Agency, pro­vid­ing the re­quired in­for­ma­tion to re­sume new pa­tient [en­roll­ment] as soon as pos­si­ble.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

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If they hold up in a second, identical trial, the data pave the way for Dupixent to become the first biologic to treat patients whose COPD remains uncontrolled despite being on maximal standard-of-care inhaled therapy — the patient population studied in the pivotal program. The companies had spotlighted this as a key readout as they look to expand the Dupixent franchise and explore its full potential.

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Alaa Halawa, executive director at Mubadala’s US venture group

The ven­ture crew at Mubadala are up­ping their biotech cre­ation game, tak­ing care­ful aim at a new fron­tier in drug de­vel­op­ment

It started with a cup of coffee and a slow burning desire to go early and long in the biotech creation business.

Wrapping up a 15-year discovery stint at Genentech back in the summer of 2021, Rami Hannoush was treated to a caffeine-fueled review of the latest work UCSF’s Jim Wells had been doing on protein degradation — one of the hottest fields in drug development.

“Jim and I have known each other for the past 15 years through Genentech collaborations. We met over coffee, and he was telling me about this concept of the company that he was thinking of,” says Hannoush. “And I got immediately intrigued by it because I knew that this could open up a big space in terms of adding a new modality in drug discovery that is desperately needed in pharma.”

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Genen­tech to stop com­mer­cial man­u­fac­tur­ing at Cal­i­for­nia head­quar­ters

Genentech is halting commercial manufacturing at its California headquarters — and laying off several hundred employees.

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Chat­G­PT with phar­ma da­ta de­buts for med­ical meet­ings, be­gin­ning with AACR

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Vas Narasimhan, Novartis CEO (Gian Ehrenzeller/Keystone via AP)

No­var­tis pulls the plug on UK-based car­dio­vas­cu­lar study

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The FDA rejected AbbVie’s 24-hour infusion therapy for Parkinson’s, saying it needs more information on a device used to administer the treatment before it can clear it.

The Chicago-area drugmaker said in a press release that the complete response letter from the agency didn’t include any requests for more efficacy or safety trials related to the drug, known as ABBV-951. The company said it aims to “resubmit the NDA as soon as possible.”

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A bid to take over the biotech Quince Therapeutics has been put forward by one of its shareholders.

On Tuesday, Echo Lake Capital sent a letter to Quince’s board of directors putting forth a proposal to acquire all the biotech’s stock for $1.60 per share, which would value a takeover at around $58 million.

In the letter, Echo Lake said that it believes Quince’s stock is severely undervalued and that no drugs are being actively marketed or developed that require cash expenditures. It’s trading below the value of its assets, Echo Lake said.

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