Armed Forces Institute of Pathology / Public domain
InnoCare Pharma, based in Beijing, China, has begun dosing patients in a late-stage study testing whether its experimental drug mesutoclax can help people with acute myeloid leukemia live longer than an established treatment. The trial pairs mesutoclax with azacitidine and compares it directly with venetoclax plus azacitidine in older patients or those unable to undergo intensive chemotherapy.
The first patient has received treatment in the China study, InnoCare said in a company release issued November 8 at 8:33 p.m. Eastern. The patients have not previously been treated for the disease. The milestone moves the program from permission to run the trial into treating participants; it does not show that the new drug works better.
Acute myeloid leukemia, or AML, is a fast-growing cancer of the blood and bone marrow. Abnormal immature blood cells crowd out healthy cells, leaving patients vulnerable to infections, anemia and bleeding. The U.S. National Cancer Institute says older age is a risk factor and that older patients can face more treatment complications. That makes treatments for people who cannot tolerate intensive chemotherapy an important part of AML care.
Venetoclax plus azacitidine is an existing treatment, not a placebo. The U.S. Food and Drug Administration granted traditional approval in 2020 for venetoclax with azacitidine, decitabine or low-dose cytarabine in newly diagnosed AML patients aged 75 or older, or adults whose other illnesses rule out intensive initial chemotherapy. Azacitidine is a chemotherapy medicine; venetoclax is a targeted drug. The U.S. approval is background on the comparator, not an approval of InnoCare’s drug or a statement about its status in China.
The direct comparison gives the study a clear test: can replacing venetoclax with mesutoclax improve survival while patients in both groups receive azacitidine? InnoCare’s August 18 trial announcement identifies overall survival, meaning how long patients live, as the main measure of success. It describes a randomized study at multiple centers, with patients assigned to treatment groups by chance. It is open-label, meaning patients and doctors know which treatment is being given.
Mesutoclax, also called ICP-248, is an oral drug that blocks BCL2, a protein involved in controlling whether a cell dies. InnoCare says blocking it is intended to restore the normal cell-death process in cancer cells. The biological aim is not proof that it will extend patients’ lives; the Phase III comparison is designed to test that question.
InnoCare calls the trial “registrational,” meaning it is intended to generate evidence for a future application to sell the treatment. China’s drug regulator authorized the trial in August. Permission to test a drug is different from permission to market it.
The company also says mesutoclax has received two breakthrough therapy designations in China. Under China’s drug-registration rules, the program supports development of qualifying treatments for serious diseases, including communication with regulators and advice on later study plans. A designation is neither a marketing approval nor a guarantee that this trial will succeed.
For patients, the question is whether the new combination can deliver longer survival with acceptable side effects against a treatment already in use. For InnoCare, the study is one of five registrational programs underway for mesutoclax across blood cancers, making its outcome part of a wider effort to develop the drug. The company, whose Beijing office is in Changping District, is listed in Hong Kong and Shanghai and develops medicines for cancer and autoimmune diseases.
The first-dosing release provides no results from this Phase III comparison. It does not give the planned number of participants or a date for results. Whether mesutoclax improves survival, how its side effects compare and whether regulators will approve this combination remain unanswered.
JBizNews Desk | Beijing
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