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Recently, AstraZeneca has been frequently dynamic in new drugs for breast cancer, in fact, AstraZeneca has already had a "heaven and earth network" layout in this field, and its bright results can be described as many, such as oral SERD, ADC, AKT
Products such as inhibitors have great potential
in various fields.
Positive clinical results for oral SERD,
Positive clinical outcome of oral SERD, positive clinical outcome of oral SERD, positive clinical outcome of clinical outcome,Bringing hope to the field
Bringing hope to the fieldThe first thing to say is oral SERD medications
Camizestrant (AZD9833), before yesterday's positive clinical results were revealed, similar products had already suffered repeated losses this year, and morale had plummeted
.
Yesterday, AZ announced the next generation of oral SERD Camizestrant
Treatment of stage II SERENA-2 in patients with estrogen receptor-positive (ER+) locally progressive or metastatic breast cancer
The study met the primary endpoint
.
It was this news that caused people in the industry to brush the screen and forward.
.
In the treatment of breast cancer, endocrine therapy (ET) is the mainstay of treatment
for estrogen receptor-positive (HR+) patients.
Estrogen receptor degraders (SERD) reduce estrogen expression and degradation by competitively binding to estrogen receptors (ER).
ER protein has become an important treatment option
for such patients.
Florvestrant was the first SERD to be approved, although its convenience and bioavailability were limited
by intramuscular administration.
Therefore, the development of the second and third generations of oral SERD has become a major direction
pursued in the industry.
However, previous R&D progress in this field has been frequently frustrated:
However, previous R&D progress in this field has been frequently frustrated:In March, Sanofi announced that the investigational oral SERD drug amcenestrant is used in stage II in patients with locally advanced or metastatic ER+/HER2- breast cancer The AMEERA-3 study failed to meet the primary PFS endpoint;
In April, Roche disclosed in its first quarter report that the oral SERD drug giredestrant failed to meet the primary endpoint of PFS, OS, in the Phase II acelERA study immature;
In August, Sanofi announced that amcenestrant in combination with pibocid is used for stage III AMEERA-5 in ER+/HER2- advanced breast cancer
The predetermined limit
for continued dosing was not reached in the interim analysis of the study.
Based on this, Sanofi terminated all clinical trials of the amcenestrant project, and the progressive oral SERD drug died
.
As a result, the positive results of this Camizestrant Phase II SERENA-2 study bring hope to the field
.
The SERENA-2 study (registration number: NCT04214288) is a randomized, open-label, parallel-group, multicenter phase II clinical trial to evaluate Camizestrant
To compare the efficacy and safety of fulvestrant in patients with ER+, HER2- advanced breast cancer who had previously received endocrine therapy.
NCT04214288 Clinical trial protocol
From: Insight Database Web (http://db.
dxy.
cn/v5/home/)
The results showed that the study met the primary endpoint: Camizestrant at doses of 75 mg and 150 mg compared to the control group with fulvestrant (500 mg).
The group showed statistically significant and clinically significant improvements
in progression-free survival (PFS).
In terms of safety, Camizestrant is well tolerated and no new safety issues
have been identified.
The specific data will be presented
at an upcoming medical meeting.
NCT04214288 Clinical trial results
From: Insight Database Web
Currently, Camizestrant has initiated 9 clinical trials in the field of breast cancer, and Camizestrant is developing for the treatment of patients with ER+/ HER2- breast cancer
The Phase III clinical SERENA-6 study (registration number: NCT04964934) for HR+, HER2- patients, which was launched last June and is scheduled to enroll 302
Trial is currently being recruited, and the trial is expected to be completed
in June 2026.
Camizestrant clinical trials in the field of breast cancer
From: Insight Database Web
Potential FIC AKT inhibitors are forthcoming
Potential FIC AKT inhibitors are forthcomingAt the same time, another blockbuster AKT inhibitor Capivasertib (AZD5363) announced by AZ yesterday is also attracting attention: the Phase III clinical CAPItello-291 study of Capivasertib in patients with HR-positive/HER2 low or negative breast cancer reached the primary endpoint
.
.
Currently, AKT-free inhibitors are approved for marketing worldwide, and Capivasertib is expected to become a FIC
.
The CAPItello-291 study (registration number: NCT04305496) is a randomized, double-blind phase III clinical trial to evaluate capivasertib
Combination with fulvestrant versus placebo plus fulvestrant in HR-positive/HER2
Efficacy and safety
in patients with locally advanced or metastatic breast cancer (who have progressed or relapsed after receiving endocrine therapy) with low or negative tumors.
The study included a total of 708 patients with the primary endpoint of progression-free survival (PFS) in the general population and a subgroup of patients with PIK3CA/AKT1/PTEN gene mutations, with approximately 40% of patients
PIK3CA/AKT1/PTEN mutation
.
NCT04305496 Clinical trial protocol
From: Insight Database Web
The results showed that the study met two primary endpoints: receiving capivasertib compared with placebo plus fulvestrant
Patients with fulvestrant had statistically significant and clinically significant improvements
in progression-free survival (PFS) in both the overall patient population and the predetermined patient subpopulation.
In addition, capivasertib
The safety profile of the combination is similar
to that observed in previous trials evaluating this combination.
Specific trial data will also be presented
at future medical meetings.
NCT04305496 Clinical trial results
From: Insight Database Web
About 70% of all new cases of breast cancer are HR-positive/HER2
Negative breast cancer is the most common type of
breast cancer.
Capivasertib (AZD5363) is a highly selective oral administration developed by AstraZeneca
AKT 1/2/3 inhibitor
.
According to the Insight database, in the field of breast cancer, Capivasertib has carried out 9
Clinical studies, including its combination chemotherapy for the first-line treatment of triple-negative breast cancer, have also entered III
Phase clinical stage (registration number: CTR20192096, NCT03997123), and completed the enrollment of the first subject in August last year
.
Capivasertib's clinical trials in the field of breast cancer
From: Insight Database Web
Areas of breast cancer:
Areas of breast cancer:AstraZeneca cast a wide net
AstraZeneca cast a wide netIn the field of breast cancer, it can be said that AstraZeneca (AZ) has cast a huge net, according to the Insight database, the AZ layout (including participation) has more than 40
A new drug under development that aims to address the biodiversity of
the breast cancer tumor microenvironment through multiple mechanisms.
For HR-positive breast cancer, AZ is designed to be implemented with the primary therapies fulvestrant and goserelin, next-generation oral SERD, and potential new agents
Camizestrant, which continues to improve outcomes
in this category of patients.
For triple-negative breast cancer, in addition to the AZ mentioned above, in evaluating the efficacy of the AKT kinase inhibitor Capivasertib in combination with chemotherapy, AZ
The effect of immunological drugs duvalumab in combination with olaparib, T-DXd and other oncology drugs is being evaluated; In addition, TROP2 targeting is being explored in collaboration with Daiichi Sankyo
The potential effect of
ADC (datopotamab deruxtecan).
And for the HER2 ADC that has long been famous
Detrastuzumab (T-DXd), AstraZeneca and Daiichi Sankyo are working together to explore the possibility
of using the drug for the treatment of earlier-line patients and for new breast cancer subtypes.
T-DXd is currently available
ClinicalTrails.
gov has registered 52 clinical trials, including 10 Phase III trials, at locations around the world
.
Clinical trial map
From: Insight Database Web
The PARP inhibitor olaparib (Lynparza/olaparib) is a targeted therapy option that has been hereditary to the BRCA mutation of HER2
Studies were conducted
in patients with negative early-stage and metastatic breast cancer.
AstraZeneca and Merck continue to explore olaparib at the BRCA
The effect of genetic mutations in patients with metastatic breast cancer, and new opportunities are being sought for such patients to receive treatment
earlier in the disease.
