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.

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