HER2-positive stomach cancer first ADC drug! AstraZeneta/13 Enhertu USA Priority Review: Redefining Gastric Cancer Treatment!

October 31, 2020 // -- AstraZeneca and Daiichi Sankyo have jointly announced that U.S. food and The Drug Administration (FDA) has accepted and granted priority review to HER2 Targeted Antibody Association Drug (ADC) Enhertu (fam-trastuzumab deruxtecan, DS-8201) for a supplemental biologics license (sBLA).
the sBLA seeks approval for Enhertu's use in the treatment of HER2-positive metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma patients.
the FDA has designated a target date for the Prescription Drug User Charge Act (PUDFA) for the first quarter of 2021.
, the FDA had granted Enhertu a breakthrough drug (BTD) for her treatment of HER2-positive stomach cancer.
the United States, there are more than 27,000 new cases of stomach cancer each year, about one-fifth of which are HER2-positive.
there are no other approved HER2 targeted drugs for metastatic gastric cancer patients who progress after initially receiving an anti-HER2 drug.
Enhertu was developed globally by The First Three and AstraZeneta, which reserved Japanese rights.
, Enhertu was approved in Japan for the treatment of HER2-positive non-excisive advanced or relapsed stomach cancer patients.
, Enhertu was awarded SAKIGAKE (Innovative Drug) by MHLW to treat HER2-positive stomach cancer.
is worth noting that Enhertu is the first ADC drug approved to treat HER2-positive stomach cancer, which will lead to meaningful progress in the treatment of these cancers.
Enhertu was the first and only HER2 targeted therapy to show significantly longer total survival (OS) than chemotherapy in HER2-positive metastatic gastric cancer patients who had previously been treated with chemotherapy and anti-HER2 therapy.
, based on the convincingly strong efficacy of clinical trials, Enhertu will be the new standard of care for clinical treatment for such patients.
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Enhertu's sBLA in the U.S. and approval in Japan are based on the results of the open label, random Phase 2 TEST-Gastric01 trial.
The trial included 187 cases (including 149 in Japan) of HER2-positive patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma (defined as IHC3 plus or IHC2 plus/ISH plus), who had previously received two or more options (including 5-FU, platinum-containing chemotherapy, tricoustojumal monoantigen) but progressed.
study, patients were randomly assigned to Enhertu (6.4 mg/kg) or chemotherapy (fir alcohol or elixir monotherapy) selected by the study investigators on a 2:1 scale, once every three weeks.
results showed that the study reached the primary and critical secondary endpoints: the Enhertu treatment group achieved statistically and clinically significant improvements in objective remission rate (ORR) and total lifetime (OS) compared to the chemotherapy group.
specific data are: of 175 patients assessable (including 140 Japanese patients), ORR assessed through independent central review (ICR): (1) ORR in the Enhertu group was 51.3% (95% CI: 41.9-60.5%), and 14.3% in the chemotherapy group (95% CI: 6.4-26.2%).
in a pre-designated interim analysis, the Enhertu group had a 41% lower risk of death than the chemotherapy group (HR=0.59; 95% CI:0.39-0.88; p=0.0097).
12.5 months in the Enhertu group and 8.4 months in the chemotherapy group.
, Enhertu's safety and tolerance were consistent with previously reported Enhertu trials.
122 (97.6%) of the 125 patients treated with Enhertu (including 99 Japanese patients) had adverse drug-related reactions.
most common adverse reactions were a reduction in neutral granulocytes (78 cases, 62.4%), nausea (72 cases, 57.6%), loss of appetite (66 cases, 52.8%), anemia (51 cases, 40.8%), plateplate reduction (48 cases, 38.4%), white blood cells Reduction (47 cases, 37.6%), fatigue 43 cases (34.4%), diarrhea (31 cases, 24.8%), hair loss (28 cases, 22.4%), decreased lymphocyte count (27 cases, 21.6%), vomiting (26 cases, 20.8%) and others.
Endertu (trastuzumab deruxtecan, DS-8201) is a new generation antibody drug coupled (ADC) that targets HER2's humanized monoclonal antibody trastuzumab (Curto bead single) through a 4 peptide link Anti) is linked to a new topological isomerase 1 inhibitor exatecan derivative (DX-8951 derivative, DXd) that targets the delivery of cytotoxic agents to cancer cells, reducing systemic exposure of cytotoxic agents compared to the usual chemotherapy.
In March 2019, AstraZeneatics entered into a $6.9 billion immuno-oncology partnership with Phase 13 to develop Enhertu for the treatment of cancer patients with various HER2 expression levels or HER2 mutations, including stomach, colorectal and lung cancer, and HER2 low expression breast cancer.
agreement, the two sides will jointly develop and commercialize Enhertu globally, with the first third retaining exclusive rights to the Japanese market and taking sole responsibility for manufacturing and supply.
December 2019, Enhertu received the world's first: FDA accelerated approval of Enhertu for adult HER2-positive metastasis breast cancer patients who have received 2 or more anti-HER2 drugs in metastasis.
Enhertu received the world's first batch in december 2019 in the United States: FDA Accelerated Approval for ADULT patients with HER2-positive metastasis breast cancer who have received 2 or more anti-HER2 drugs in metastasis diseases.
Previously, the FDA has granted Enhertu three breakthrough drug qualifications (BTD):(1) for the treatment of metastasis non-small cell lung cancer (NSCL) that progresses during or after receiving platinum-containing chemotherapy and has HER2 mutations in tumors C) patients; (2) HER2-positive, non-excisive or metastatic gastric or gastroesophageal junction adenocarcinoma patients who have previously received at least 2 programs (including trastuzumab) and (3) for the treatment of HER2-positive metastatic breast cancer patients, which were approved in December 2019.
industry is very bullish on Enhertu's business prospects, with pharmaceutical market research agency Evaluate Pharma predicting Enhertu's sales to reach $2 billion by 2024.
() Original origin: Enhertu granted Priority Review in the US for the treatment of HER2-positive metastatic gastric cancer<!--/ewebeditor:page->