Three-negative breast cancer (TNBC) first-line treatment! Roche Tecentriq (Tesanci) - Clinical failure of Chemotherapy Phase III!

August 07, 2020 // -- Roche recently released the latest results of a Phase III Impassion 131 study evaluating anti-PD-L1 therapy Tecentriq (Tezolizumab, atezolizumab, atezolizumab) combined chemotherapy (yew alcohol) for the first-line treatment of metastatic tri-negative breast cancer (TNBC).
The study, a multicenter, randomized, double-blind study of patients with previously untreated, non-excisible, partially advanced, or metastatic TNBC patients, assessed the efficacy and safety of Tecentriq," placebo, and yew alcohol.
study, 651 patients were randomly assigned at a 2:1 ratio to receive Tecentriq plus yew alcohol, placebo and yew alcohol, respectively.
end points were progression-free survival (PFS) in the PD-L1-positive population, followed by PFS in the intentional therapy (ITT) group.
secondary endpoints include total survival (OS), objective mitigation rate (ORR), and mitigation duration (DOR) for PD-L1-positive and ITT populations.
results showed that in the PD-L1-positive patient population, the Tecentriq plus yew alcohol program did not reach statistical significance in terms of the main endpoint PFS compared to placebo plus yew alcohol.
of the secondary endpoint OS is negative and immature at the time of analysis.
OS follow-up will proceed as planned until the final analysis.
the safety of tecentriq and yew alcohol combinations is consistent with the known safety of each drug, no new safety signals have been found.
In a previous Phase III IMpassion 130 study, Tecentriq's combined application with the chemotherapy drug abraxane (nab-paclitaxe, albumin-binding yew alcohol) showed statistically significant PFS benefits, although not formally tested, for metastatic TNBC patients with tumor expression PD-L1 (-1%), the improvement in OS was clinically significant.
to date, tecentriq-Abraxane has been approved in more than 70 countries for the treatment of non-excisible local late stage or metastatic TNBC patients with tumor expression PD-L1 (-1%).
results of the IMpassion 131 study will be discussed with global health authorities and will be presented at future medical meetings.
these insights will also be used to guide current and future Tecentriq plus yew alcohol therapy for TNBC research. "While we are disappointed with the results of the Ampassion 131 study, we are grateful to all the patients, families and doctors involved in the study," said Dr. Levi Garraway, Chief Medical Officer and Global Product Development Director at
Roche.
today's findings highlight the need to better understand the interactions between cancer and the immune system, including the main course of chemotherapy and related programmes.
remain committed to finding the best treatment for all patients with this invasive disease.
june, Roche released positive results from TNBC's Phase III Ampassion031 study for Early TNBC's Phase III I Chemotherapy Treatment.
data showed that the study reached a major endpoint: for new complementary (preoperative) therapy, the Tecentriq plus chemotherapy (Abraxane, followed by amycin and cyclophosphamide) programme showed a statistically significant improvement in pathological total remission (pCR), regardless of PD-L1 expression.
pCR is a commonly used evaluation index of the efficacy of new complementary treatments, which can be evaluated more quickly in early stage breast cancer than in traditional endpoints.
noteworthy, the IMpassion 031 study is Roche's second positive Phase III study to confirm Tecentriq's therapeutic benefits at TNBC, and the first to demonstrate Tecentriq's therapeutic benefits in the early stages of TNBC.
is the most common type of cancer in women, with more than 2 million cases diagnosed worldwide each year.
about 15 percent of TNDs, which are more common among women under the age of 50 than other types.
TNBC refers to estrogen receptors (ERs), progesterone receptors (PR) and human epiderm growth factor receptors 2 (HER-2) all of which are negative for breast cancer, with rapid progression and poor prognostication, with a five-year survival rate of less than 15%.
TNBC has been ineffective in both hormone therapy and HER2 targeted therapies, such as Hersheytin, and treatment options are limited, relying heavily on chemotherapy.
metastatic TNBC is one of the most invasive and difficult to treat.
Tecentriq belongs to PD-(L)1 tumor immunotherapy, which targets the expression of PD-L1 proteins in tumor cells and tumor-immersed immune cells, blocking their interaction with PD-1 and B7.1 receptions.
by inhibiting PD-L1, Tecentriq can activate T cells.
To date, Tecentriq has been approved in several countries as a single-drug therapy and combination of targeted therapies and/or chemotherapy to treat a wide range of types of cancer, including: non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC), certain types of metastatic urinary trachea (mUC), PD-L1 positive triple negative breast cancer (TNBC), etc.
() Original source: Roche provides update on Phase III study of Tecentriq in combination with paclitaxel for people with metastatic triple-negative breast cancer.