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July 20, 2021

Roche’s Hemlibra demonstrates safety in Phase III haemophilia A trial

STASEY trial found that the bispecific antibody had a low occurrence of anti-drug antibody development. 

Roche has reported data from the final analysis of the Phase IIIb STASEY trial, validating the favourable safety profile of Hemlibra (emicizumab) in haemophilia A, an inherited bleeding disorder.

Hemlibra is a bispecific factor IXa- and factor X-directed antibody designed by Chugai Pharmaceutical. The drug is currently being developed jointly by Chugai, Roche and Genentech globally.

It works by combining factors IXa and X, proteins involved in the natural coagulation cascade, as well as re-establishes the blood clotting process in haemophilia A patients.

In haemophilia A patients, clotting protein called factor VIII is absent or is in low levels. Factor VIII brings the clotting factors IXa and X together to stop bleeding in healthy people.

The final analysis of the STASEY trial comprises results from 193 haemophilia A patients with factor VIII inhibitors. They were given Hemlibra prophylaxis once a week for up to two years.

No new safety signals or new cases of thrombotic microangiopathy or serious thrombotic events associated with Hemlibra were observed in the open-label trial.

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Joint pain, common cold symptoms, headache, fever, and injection site reaction were the most common adverse events noted in the participants.

The study established that Hemlibra is linked to a reduced occurrence of anti-drug antibody (ADA) development.

About ten subjects had ADAs that did not affect Hemlibra’s efficacy or safety and receded eventually.

Hemlibra also provided bleeding control with nearly 82.6% of subjects having no bleeding episodes that needed treatment.

The latest data is in line with results from the Phase III HAVEN clinical programme of the drug.

Roche Global Product Development head and chief medical officer Levi Garraway said: “As the treatment landscape evolves, determining the long-term benefit/risk profile of medicines for people living with haemophilia A remains a top priority for the community.

“These results provide further confidence in Hemlibra’s favourable safety profile in people with haemophilia A with factor VIII inhibitors, who have historically faced significant treatment challenges.”

Last month, Roche reported additional positive data of Venclexta/Venclyxto from pivotal Phase III CLL14, MURANO and VIALE-A clinical trials.

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