Triple Negative Breast Cancer (TNBC) Immunotherapy! Mercedon Keytruda's treatment of high-risk early TNBC was rejected by the FDA committee!

February 14, 2021 // -- Merck and Co recently announced the results of a meeting of the U.S. Food and Drug Administration's (FDA) Advisory Committee on Oncology and Drugs (ODAC), which discussed anti-PD-1 therapy . DA, generic name: Pembrolizumab, Pabliju monoantigen( sBLA) for the treatment of high-risk early triple negative breast cancer (TNBC) patients, specifically: the Keytruda combination chemotherapy for new auxiliary (preoperative) treatment, and then Keytruda as a single drug for complementary (postoperative) treatment.
TNBC is a hard-to-treat malignancy, with about 15-20% of breast cancer patients diagnosed with TNBC.
committee voted 10 to 0 against, arguing that the review decision should be deferred until further data are available for the third KEYNOTE-522 study.
the study reached one of the dual primary endpoints of pathological complete remission rate (pCR) and the event-free lifetime (EFS) is continuing to be evaluated.
ODAC provides independent expert advice and recommendations to the FDA on listed and research drugs used to treat cancer.
FDA is not bound by committee guidance, but will consider its recommendations.
2020, the FDA accepted two sBLA copies of Keytruda's treatment for TNBC.
one of the sBLA was given priority review and accelerated approval in November 2020: Keytruda combined chemotherapy to treat patients with local relapse non-excisive or metastasis TNBC patients with tumor expression PD-L1 (combined positive score (CPS) ≥10).
note that the approval marks Keytruda's first in the field of breast cancer.
another standard review of sBLA: the use of Keytruda for high-risk early TNBC patients.
the FDA has set a target date of March 29, 2021 for the sBLA's Prescription Drug User Charge Act.
the sBLA is based on data from the 3st ISSUE KEYNOTE-522 study, the next interim analysis of which is calendar-driven and is expected to be released in the third quarter of 2021.
"Triple negative breast cancer (TNBC) is an invasive disease, and we all agree that patients with early stage disease need more choices," said Dr. Roy Baynes, Chief Medical Officer, Senior Vice President and Director of Global Clinical Development at Mercedon Research Laboratory.
we are disappointed with the outcome of today's meeting, we believe Keytruda can help meet the unseeded medical needs of these patients.
are confident in the results of the KEYNOTE-522 trial, including observed pathological full remission rates and encouraging medium-term event-free survival data.
look forward to continuing to work with the FDA to review our application.
we thank all the patients, caregivers and health care providers involved in this study.
"KEYNOTE-522 is a randomized, double-blind trial conducted in high-risk early TNBC patients that evaluated the use of Keytruda combined chemotherapy and placebo combination chemotherapy for new preoperative complementary therapy, followed by Keytruda and placebo for postoperative complementary therapy.
data showed a statistically significant increase in pathological total remission (pCR) in keytruda-plus chemotherapy (n-401) regardless of PD-L1 expression status during the new adverbic treatment period (pCR: 64.8% vs 51.2%, p-0.00055).
In another major endpoint, event-free lifetime (EFS), median follow-up was 15.5 months, and the Keytruda programme showed a favourable trend in EFS compared to the chemotherapy-placebo programme, reducing the risk of progression and secondary recurrence of new secondary diseases by 37% (HR=0.63 (95% CI: 0.43-0.93)."
it's worth noting that, based on this study data, Keytruda is the first anti-PD-1 therapy to show a statistically significant improvement in pCR as a new complementary therapy for TNBC (regardless of PD-L1 status).
, the FDA has granted Keytruda Plus chemotherapy a breakthrough drug qualification (BTD) for new complementary treatments in high-risk early TNBC patients.
keytruda is an anti-PD-(L)1 tumor immunotherapy that helps detect and fight tumor cells by improving the body's immune system.
Keytruda is an anti-PD-1 therapy that activates T lymphocytes that may affect tumor cells and healthy cells by blocking the interaction between PD-1 and its mediators PD-L1 and PD-L2.
, Keytruda has become the basic treatment for many types of cancer.
has more than 10 anti-PD-(L)1 therapies approved for sale worldwide, with Keytruda leading the list, with global sales of $14.38 billion in 2020, up 30 percent from the previous year.
comes after a report by Evaluate Pharma, a pharmaceutical market research group, predicted keytruda would sell $24.91 billion in sales in 2026, making it the world's best-selling drug.
sales of the PD-1 anti-PD-1 therapy Opdivo (Odivo, Navuliyu monoanti) will also reach $12.677 billion, making it the world's second-best-selling drug.
is the most common type of cancer among women, with more than 2 million cases diagnosed worldwide each year.
TNBC accounts for about 15-20% of all breast cancers, and is more common among women under 50 than other types of breast cancer.
TNBC refers to estrogen-infused (ER), progesterone-like (PR) and human skin growth factor 2 (HER-2) are all negative expressions of breast cancer, which is an invasive breast cancer that progresses rapidly, has a very poor prognostic prognosticity, has a high recurrence rate, and has a five-year survival rate of less than 15%.
TNBC is ineffective for hormone therapy and HER2 targeted therapies such as Hessetin, and clinical options are limited, relying heavily on chemotherapy.
TNBC is one of the most invasive and difficult breast cancers to treat.
TNBC New Drug, March 2019, FDA Approves Roche Anti-PD-L1 therapy Tecentriq (Tershanqi, generic name: atezolizumab, Atlaxane) combined chemotherapy (Abraxane) first-line treatment of PD-L1 positive non-excisive local late stage or metastasis TNBC patients.
the approval, making the Tecentriq-Abraxane combination the first cancer immunotherapy treatment for PD-L1-positive metastasis TNBC.
in the Phase III IMpassion130 study, the Tecentriq-Abraxane programme significantly reduced the risk of disease progression or death by 40% in PD-L1-positive patients compared to the placebo-Abraxane programme (medium PFS: 7.4 months vs 4.8 months, HR -0.60,95% CI :0.48-0.77, p<0.0001), resulting in a 7-month improvement in clinical significance for total lifetime (OS) (medium OS: 25.0 vs 18.0 months, HR=0.71,95%CI:0.54-0.93).
April 2020, the FDA approved Immunomedics' antibody drug concedes (ADC) Trodelvy (sacituzumab govitecan-hziy) for adult patients with metastasis triple-negative breast cancer (mTNBC) who had previously received at least two treatments for metastasis diseases.
it's worth noting that Trodelvy is the first FDA-approved ADC drug specifically for relapsed or refractic mTNBC, and the first FDA-approved anti-Trump-2 ADC drug.
data from the single-arm multi-center Phase II IMMU-132-01 study show that the objective remission rate of Trodelvy therapy was (in adult patients with overtreatment of metastasis) who had previously received multiple treatments (range: 2-10) for metastasis. ORR) is 33.3% (95% CI: 24.6, 43.1), and the medium mitigation duration (DOR) is 7.7 months (95% CI: 4.9, 10.8).
November 2020, the FDA approved Mercedon anti-PD-1 therapy Keytruda, a combination of chemotherapy to treat patients with local relapse non-excisive or metastasis TNBC with tumor expression PD-L1 (combined positive score (CPS) ≥10).
approval is based on data from the 3nd KEYNOTE-355 Study (NCT02819518).
the study was conducted in patients with local recurrence, non-excisive, or metastasis TNBC who had not previously received chemotherapy to treat metastasis.
results showed that in patients with tumor expression PD-L1 and combined positive score (CPS)≥10 (38 percent of the study group), the risk of disease progression or death in the Keytruda plus chemotherapy group was significantly reduced by 35 percent compared to the placebo-chemotherapy group (HR-0.65) 95% CI:0.49-0.86; p-0.0012), progress-free lifetime (PFS) showed significant statistical and clinical significance (medium PFS: 9.7 months vs 5.6 months).
addition, the objective remission rate (ORR) was 53% for the Keytruda plus chemotherapy group (17% for the complete remission rate and 36% for the partial remission rate (PR) and 40% for the placebo plus chemotherapy group (CR for 13% and PR for 27%).
19.3 months in the Keytruda plus chemotherapy group and 7.3 months in the placebo plus chemotherapy group.
study, Keytruda's medium duration of treatment was 5.7 months.
the Recommendations of the Independent Data Monitoring Board (DMC), the study will continue without any changes to assess the total lifetime (OS) of another dual primary endpoint.
() Origin: Merck Announces Outcomes of Oncologic Drugs Advisory Committee (ODAC) for KEYTRUDA® (pembrolizumab) for Treatment of Patients With High-Risk Early-Stage Triple-Negative Breast Cancer (TNBC) <!--/ewebeditor:page->