Oral yew alkane treatment of breast cancer phase 3 clinical end of adverse reactions or worry.

On August 24, Odonate Therapeutics announced the positive results of Tesetaxel (a researched oral dosage form of yew) for the treatment of phase 3 clinical studies in patients with metastasis breast cancer (MBC).
results showed that the study reached the main endpoint of improving patient progressity without progressability (PFS).
CONTESSA is a multi-national, randomized Phase 3 clinical study aimed at reducing the dose of Capecitabine by oral Tesetaxel (27mg/m2) on the first day of the 21-day treatment cycle , 14 days of oral 1650 mg/m2/day in a 21-day cycle is compared to receiving the standard dose of capedabin alone (2500 mg/m2/day for 14 days in 21 days).
685 patients in the study were randomly divided into two groups according to 1:1 in patients with human skin growth factor 2 (HER2) negative and hormone-positive (HR).
is an oral chemotherapy drug that is considered the standard for MPC care.
if required, patients must receive endocrine therapy, regardless of the use of cell cycle protein-dependent kinase (CDK) 4/6 inhibitors.
end point of the study was PFS assessed by the Independent Radiology Review Board (IRC), and the secondary endpoint was total survival rate (OS), objective response rate (ORR) assessed by IRC, and disease control rate (DCR).
according to the IRC assessment, the average PFS in the tesetaxel combined carpedabin reduction programme group was 9.8 months, compared with 6.9 months in the standard dose group of carpestabin alone, a relative improvement of 2.9 months.
addition, the dose of tesetaxel combined with capedabin was reduced by 28.4% compared to the standard dose of tesetaxel combined with carpedabin .716 (95% CI: 0.573-0.895) ;p .003).
the results were positive, the adverse reactions in the combined drug group were significantly higher than those in the carpedabin single drug group.
Patients with level 3 and above had adverse events (TEAEs), including a reduction in neutral granulocytes (71.2% in the joint group, 8.3% in the single-drug group), diarrhea (13.4% in the joint group, 8.9% in the single-drug group), hand-foot syndrome (6.8% in the joint group, 12.2% in the single-drug group), and fever-neutral cell reduction (combined). Group 12.8%, single-drug group 1.2%), fatigue (joint group 8.6%, single-drug group 4.5%), hypokalemia (joint group 8.6%, single drug group 2.7%), leucinocyte reduction (joint group 10.1%, single drug group 0.9%), anemia (joint group 8.0%, single drug group 2.1%).
of stage 2 hair loss was 8.0 per cent in the combined group and 0.3 per cent in the single drug group.
of neuropathy in the combined group was 5.9%, compared with 0.9% in the single-drug group.
Odonate noted that while the OS data in the current study is premature, a recent interim analysis showed that tesetaxel combined with Capatham had no adverse effects on OS, and that the final analysis of the study is expected to take place in 2022.
"Tesetaxel represents a potentially important clinical advance for patients with metastasis breast cancer, for which there are still significant unsolved medical needs," said Dr. Joyce O'Shaughnessy, co-lead researcher at contESSA and president of breast cancer research in the United States.
latest update to the U.S. National Comprehensive Cancer Network guidelines highlights this need and recommends oral medications to reduce the frequency of outpatient visits.
Odonate, a pharmaceutical company dedicated to the development of "best-in-class" therapies, initially focused on tsetaxel.
This is a research oral chemotherapy drug that belongs to the yewtan drug (widely used in cancer treatment) but is considered a new chemical entity (NCE), which retains the same yew alkane core as the approved yewane drug, but adds two new nitrogen-containing functional groups.
Tesetaxel's chemical design is: (1) not to be pumped out of the body by P-glycoprotein ("P-gp") in order to maintain the activity of chemotherapy-resistant tumor cells;
These designs enable tesetaxel to have a variety of pharmacological properties, including low oral doses, long plasma half-life, the ability to maintain adequate drug levels at relatively small doses, a history of non-allergic reactions, and significant inhibition of chemotherapy-resistant tumors.
MPC patients, the drug showed significant single-dose anti-tumor activity in two multi-center Phase 2 clinical studies.
chemical and pharmacological properties of sequoia, dositaxel and tesetaxel Reference source: Odonate Therapeutics Announces Positive Top-line Results from CONTESSA, a Phase 3 Study of Tesetaxel in Patients with Metast Breast Cancer.