The FDA has approved Odivo's combination of epipentome monotherapy for previously untreated, non-removable patients with malignant thoracic mesothelioma, becoming the first and only immunotherapy to be approved.

The U.S. Food and Drug Administration (FDA) has approved Odivo (360 mg, once every 3 weeks) in a joint epipentome (1 mg/kg, once every 6 weeks) for first-line treatment of non-excisive malignant thoracic mesothelioma (MPM) adult patients.
approval is based on an in-preset period analysis of Phase III clinical study CheckMate -743.
study showed that after at least 22.1 months of follow-up, the total lifetime (OS) of patients in Odivo's combined ipymu monoantigroup (n-303) was better than that of the platinum-containing standard chemotherapy group (n-302) (risk ratio: 0.74 ( 95 percent confidence interval: 0.61), 0.89) ;p-0.002), the medium total survival (mOS) of the double immunotherapy group was 18.1 months (95% confidence interval: 16.8, 21.5), and the chemotherapy group was 14.1 months (95% confidence interval: 12.5, 16.2).
2-year survival rate was 41% for patients in the two-year immunotherapy group, compared with 27% in the chemotherapy group.
"Malignant thoracic mesothelioma is a rare cancer with limited treatment options," said Dr. Anne S. Tsao, director of the Chest Medicine Oncology Department at the University of Texas Anderson Cancer Center and director of the mesothelioma program.
for patients who were late at the time of diagnosis, the five-year survival rate was only 10%.
of CheckMate-743 suggests that Odivo combined with Ipimu monoantigen will become a new first-line standard treatment option.
is exciting news, and it offers hope not only to patients with this serious disease, but also to the health care workers who care about them.
" Odivo combined with EpiPen anti-treatment warnings and precautions include immuno-mediated adverse events, respectively, pneumonia, colitis, hepatitis, endocrine diseases, nephritis and renal inseventry, adverse skin reactions, encephalitis and other adverse reactions; Reactions: Complications of stem cell transplantation using donor stem cells (allogeneic transplants); embryo-fetal toxicity; increased mortality in patients with multiple myeloma when Odyssey is used in association with salidamine similars and dexamysong, and is therefore not recommended for use outside controlled clinical trials.
The warnings and precautions for the use of ipigum monoantigen are: severe and fatal immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplantation following the use of ipsomu monoantigen, embryo-fetal toxicity, and associated risks associated with Odivo.
this is the third adaptation certificate approved for first-line treatment in chest tumors by Odivo's joint Ipimu monoantigen.
previously, the FDA had approved Odivo's combined Ipimu monoantigen for first-line treatment in patients with metastasis non-small cell lung cancer (NSCLC), who were subject to FDA-approved PD-L1 testing to determine their PD-L1 expression ≥1 percent without EGFR or ALC gene mutations.
In addition, the FDA has approved Odivo's combined ipsomosis and limited course of chemotherapy for first-line treatment in adult patients without EGFR or ALC gene mutations, which can be used by patients receiving the treatment regardless of their PD-L1 expression or not.
Lenkowsky, U.S. general manager and head of oncology, immunology and cardiovascular medicine at
, said: "Chest tumors are complex and difficult to treat, and we are focused on developing immunotherapy that promises to prolong a patient's life.
just a few months ago, immunotherapy based on Odivo's combined Ipimu monoantigen was approved for two first-line adaptations in specific patients with non-small cell lung cancer.
now, Odivo's joint epipentome has been approved in another chest tumor for patients with previously untreated, non-removable malignant thoracic mesothelioma.
based on today's approval, Odivo's joint Ipimu monotherapy will be the first new systemic therapy approved in the field in more than 15 years, promising to help these patients prolong their lives.
"Odivo combined with Ipimu monoantigen is a unique combination of two immuno checkpoint inhibitors with potential synergetic mechanisms for two different checkpoints (PD-1 and CTLA-4) to help eliminate tumor cells: Ibico monoigen helps activate and multiply T cells, while Odivo helps existing T cells detect tumors.
T cells activated by Ipimu monoantigen can be differentiated into memory T cells, which is expected to lead to a long-term immune response.
may also target normal cells, leading to adverse immune-mediated reactions.
this reaction can be severe and even fatal.
this time, the FDA approved a new Supplemental Biologics Licensing Application (SBLA) in less than six weeks through the Real-Time Oncology Review (RTOR) pilot program, which aims to ensure safe and effective treatment for patients as early as possible, and has joined the FDA's Orbis program, which has been reviewed in sync with the FDA by health regulators in Australia, Canada and Singapore.
(Ipymu monoantigen is not yet available on Chinese mainland) About CheckMate -743CheckMate-743 is an open label, multi-center, randomized, Phase III clinical study designed to evaluate and standard chemotherapy (Pemetroser combined with cisplatin or card Platinum) compared to Odivo's combined epipentome is used to treat patients with a malignant thoracic mesothelioma that has been confirmed to be non-removable by histological credit type and who have not under been systematically treated or palliative radiotherapy within 14 days prior to the start of treatment (n-605).
the trial excluded patients with interstitific lung disease, active autoimmune disease, clinical need for systematic immunosuppression, or active brain metastasis.
in this clinical study, 303 patients were treated randomly with Odivo (3 mg/kg, once every 2 weeks) and Ipimu monoantigen (1mg/kg, once every 6 weeks).
302 patients were randomly treated with cisplatin (75 mg/m2) or carptin (AUC 5) combined with 500 mg/m2 for 6 cycles every 3 weeks.
two groups of patients continue to receive treatment until the disease progresses or is unacceptablely toxic.
in the Odivo combined Ipimu monoantigroup, the maximum treatment time for patients was 24 months.
end point of the trial was total lifetime (OS) for all randomized patients, and other efficacy indicators included progress-free lifetime (PFS), objective mitigation rate (ORR), and continuous mitigation time (DOR), which were evaluated by BICR against the revised RECIST criteria.
CheckMate-743 study part of the safety data of patients receiving Odivo combined Ipimu monoantimmune treatment in 23% of patients due to adverse reactions permanently stopped treatment, 52% of patients due to adverse reactions at least once stopped treatment, and 4.7% of patients due to adverse reactions permanently discontinued Ipimu monoantigen.
54% of patients who received Odivo's combined Ipimu monotherapy had severe adverse reactions.
The most common serious adverse reactions (≥2%) were pneumonia, fever, diarrhea, limited pneumonia, chest fluid build-up, dyspnea, acute kidney injury, infusion-related reactions, musculoskeletal pain and pulmonary embolism.
4 (1.3%) patients had fatal adverse reactions, including limited pneumonia, acute heart failure, sepsis and encephalitis.
the most common adverse reactions (≥20%) were fatigue (43%), musculoskeletal pain (38%), rash (34%), diarrhea (32%), breathing difficulties (27%), nausea (24%), decreased appetite (24%), cough (23%) and itching (21%).
the number of treatments in Odivo was 12 and the number of mesothetic treatments in Ipimu was 4.
that malignant thoracic mesothelioma mesothelioma is a rare and highly invasive malignant tumor native to mesothelioma cells.
about 3,000 cases are confirmed each year in China.
16 malignant thoracic mesothelioma is the most common type of mesothelioma.
the incidence is highly associated with asbestos exposure.
delayed diagnosis, most patients were terminally ill at the time of diagnosis.
the prognosis of malignant thoracic mesothelioma is generally poor, the medium survival of patients with advanced malignant thoracic mesothelioma is about one year, and the five-year survival rate is about 10%.
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