Lethal ex­per­i­men­tal can­cer drug from Han­mi, Boehringer killed three pa­tients — re­port

Ko­re­an health of­fi­cials have tied the deaths of three pa­tients to a can­cer drug launched by Han­mi Phar­ma­ceu­ti­cals and part­nered with Boehringer In­gel­heim, ac­cord­ing to a fol­lowup sto­ry in The Ko­rea Her­ald.

Cit­ing a re­port from the coun­try’s Min­istry of Food and Drug Safe­ty, which was re­leased by Rep. Kwon Mi-hyuk to­day, the three were a 75-year-old pa­tient who died in late 2015, a 57-year-old who died in March and a 54-year-old who died in June.

Al­to­geth­er eight pa­tients died in the study, ac­cord­ing to the Her­ald’s re­port­ing of the min­istry re­view, with 29 “se­ri­ous ad­verse events and ad­verse drug re­ac­tions,” though health of­fi­cials have not con­firmed a link with the drug in every case.

Late Fri­day, Boehringer is­sued a tardy re­sponse to End­points News.

“Boehringer In­gel­heim in­formed reg­u­la­to­ry au­thor­i­ties, in­clud­ing the FDA, about rel­e­vant safe­ty da­ta re­lat­ed to ol­mu­tinib, in­clud­ing side ef­fects such as se­vere skin re­ac­tions men­tioned in the drug safe­ty let­ter,” the com­pa­ny said in a state­ment. “At the same time Boehringer In­gel­heim in­formed all in­ves­ti­ga­tors. We al­so made sure pa­tients re­ceived time­ly com­mu­ni­ca­tions and up­dat­ed their con­sents re­gard­ing these find­ings. We are not aware of any ad­di­tion­al of­fi­cial re­port or com­mu­ni­ca­tion is­sued by the South Ko­re­an Au­thor­i­ty.”

Boehringer In­gel­heim abrupt­ly washed its hand of the drug just days ago with­out ini­tial­ly rais­ing any is­sues with deaths or ad­verse events. Queried by End­points News, a spokesper­son for the com­pa­ny pro­vid­ed a state­ment say­ing that Ko­re­an of­fi­cials had is­sued a let­ter re­fer­ring to “two cas­es of tox­ic epi­der­mal necrol­y­sis, one of them fa­tal, and one case of Stevens-John­son-Syn­drome (non-fa­tal).”

The ap­pro­pri­ate reg­u­la­tors, the com­pa­ny added, had been in­formed of “rel­e­vant safe­ty da­ta re­lat­ed to ol­mu­tinib, in­clud­ing side ef­fects such as se­vere skin re­ac­tions.” Boehringer not­ed that the two cas­es of tox­ic epi­der­mal necrol­y­sis oc­curred in two stud­ies: HM-EM­SI-101 and HM-EM­SI-202. The 101 study is list­ed on clin­i­cal­tri­als.gov as spon­sored by Han­mi with Boehringer cit­ed as a col­lab­o­ra­tor.

Not long ago, though, Boehringer — which has paid Han­mi $65 mil­lion of a $730 mil­lion deal — had been ea­ger to see if it could quick­ly put the drug through a mid-stage study and then seek a fast ap­proval.

Back in May, two months af­ter the sec­ond pa­tient death re­port­ed by Ko­re­an of­fi­cials, Boehringer put out a re­lease tout­ing the Ko­re­an ap­proval of the drug, stat­ing:

Ol­mu­tinib (BI 1482694 / HM61713) is a nov­el third-gen­er­a­tion, oral, EGFR mu­ta­tion-spe­cif­ic TKI. It is cur­rent­ly in ac­cel­er­at­ed de­vel­op­ment through the am­bi­tious ELUXA clin­i­cal tri­al pro­gramme with the aim to sub­mit da­ta and ev­i­dence to the US FDA and EU EMA in 2016. The piv­otal Phase II tri­al ELUXA 1 (HM-EM­SI-202 (NCT02485652) is on­go­ing, en­rolling EGFR T790M mu­ta­tion-pos­i­tive lung can­cer pa­tients who have be­come re­sis­tant to pre­vi­ous TKI treat­ment.

“This first ap­proval of ol­mu­tinib is an ex­cit­ing mile­stone for the com­pound and we are work­ing dili­gent­ly to make this nov­el treat­ment op­tion glob­al­ly avail­able to pa­tients and physi­cians as quick­ly as pos­si­ble,” said Boehringer on­col­o­gy chief Jörg Barth, in a state­ment.

Han­mi, mean­while, is now un­der in­ves­ti­ga­tion to see if there was any in­sid­er trad­ing of com­pa­ny stock around the re­port on ad­verse events, which came out just hours af­ter the com­pa­ny com­plet­ed a tie-up with Genen­tech. In the mean­time, Ko­re­an of­fi­cials have re­port­ed­ly de­cid­ed to keep the drug on the mar­ket un­der the con­di­tion­al ap­proval that was hand­ed out ear­li­er in the year. Even though there was one re­port­ed pa­tient death at the time, they said, they had no di­rect link to the drug. Pa­tients would have to be in­formed of the risks, they said, be­fore they were giv­en the drug.

Look­ing to make a big move in­to brand­ed drugs, Han­mi has been rack­ing up a se­ries of part­ner­ships with mar­quee drug de­vel­op­ers. Just yes­ter­day Genen­tech signed on to part­ner on an ear­ly-stage can­cer drug. Last fall, Sanofi paid €400 mil­lion up­front to part­ner with Han­mi on a port­fo­lio of di­a­betes drugs. Be­fore that, there was a pact with Eli Lil­ly worth up to $690 mil­lion on an au­toim­mune drug for a va­ri­ety of dis­eases. And J&J has al­so part­nered with Han­mi, which has been beef­ing up its R&D arm in a con­cert­ed ef­fort to build a port­fo­lio of brand­ed ther­a­pies.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

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Doug Giordano might have some thoughts on how that could work out.

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In a Phase III trial, patients given a 5-day dose of remdesivir were 65% more likely to show “clinical improvement” compared to an arm given standard-of-care. The trial, though, gave little indication for whether the drug had an impact on key endpoints such as survival or time-to-recovery. And in a surprising twist, a 10-day dosing arm of remdesivir didn’t lead to a statistically significant improvement over standard of care.

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