November 11, 2022 07:00 GMT
The approval is based on the results of the phase III POSEIDON study, which showed a significant survival benefit with limited treatment with Imjudo in addition to Imfinzi and chemotherapy
ist AstraZenecaSummary(durvalumab) in combination withImjudo(tremelimumab) plus platinum-based chemotherapy was approved in the US for the treatment of adult patients with stage IV (metastatic) non-small cell lung cancer (NSCLC).
The Food and Drug Administration (FDA) approval was based on the findings of thePOSEIDON-Phase-III-Studie. Patients treated with a limited five-cycle regimen of anti-CTLA-4 antibodiesImjudoadded toSummaryplus four cycles of platinum-based chemotherapy demonstrated a 23% reduction in risk of death compared to a variety of chemotherapy options (based on a hazard ratio [HR] of 0.77; 95% CI 0.65-0.92; p=0.00304 ). It is estimated that 33% of patients were alive at two years, versus 22% with chemotherapy. This treatment combination also reduced the risk of disease progression or death by 28% compared to chemotherapy alone (HR 0.72; 95% CI 0.60-0.86; p=0.00031).
updated resultsof the phase III POSEIDON study after approximately four years of follow-up at the European Society of Medical Oncology (ESMO) 2022 Congress and published inJournal of Clinical Oncologydemonstrated a sustained survival benefit and improved overall survival (OS) by 25% compared to chemotherapy alone (HR 0.75; 95% CI 0.63-0.88). An estimated 25% of patients treated with the combination were alive after three years, compared to 13.6% of patients treated with chemotherapy alone. The security profile forImjudomoreSummaryand chemotherapy were consistent with the known profiles of each drug, and no new safety signals were identified.
In the United States, lung cancer is the second most commonly diagnosed cancer, with more than 236,000 patients expected in 2022.1The prognosis is particularly poor in patients with metastatic NSCLC, as only about 8% will live more than five years after diagnosis.2
Melissa Johnson, MD, Director of Lung Cancer Research, Sarah Cannon Research Institute at Tennessee Oncology in Nashville, Tennessee, and Principal Investigator of the Phase III POSEIDON trial, said, "Metastatic non-small cell lung cancer remains an important treatment challenge, because many patients' tumors do not respond well to standard therapies, including checkpoint inhibitors. The approval of this dual chemotherapy-immunotherapy regimen introduces a generally well-tolerated new treatment option for patients with this devastating disease and gives them the opportunity to benefit from the long-term survival benefit observed with CTLA-4 inhibition."
Dave Fredrickson, AstraZeneca's Executive Vice President, Oncology Business Unit, said: "This approval underscores the importance of delivering new treatment combinations that prolong survival in metastatic non-small cell lung cancer, a complex scenario in which many patients remain grim prognosis are faced. This is the second clue forImjudoadded toSummarywithin just weeks of its approval in inoperable liver cancer, underscoring the benefits of this new drug and our commitment to improving patient outcomes in cancer settings with persistent unmet needs.”
Based on the POSEIDON results, regulatory submissions for this indication are also under review in Europe, Japan and several other countries.
Summaryis the only approved immunotherapy and the global standard of care in the intended curative cessation of unresectable stage III NSCLC in patients whose disease has not progressed following chemoradiotherapy, based on the Phase III PACIFIC trial.SummaryIt is also approved in the US, EU, Japan, China and many other countries worldwide for the treatment of advanced-stage small cell lung cancer (ES-SCLC) based on the CASPIAN phase III study.Summaryis approved and co-approved in the US and several other countries in combination with chemotherapy for the treatment of locally advanced or metastatic bile duct cancer based on the phase III TOPAZ-1 studyImjudoin the US for the treatment of inoperable hepatocellular carcinoma based on the HIMALAYA phase III study.
NSCLC im Stadium IV
Lung cancer is the second most common cancer worldwide, with over two million patients diagnosed in 2020.3Lung cancer is roughly divided into NSCLC and SCLC, with 80-85% classified as NSCLC. Within the NSCLC, patients are classified as squamous cell carcinoma, accounting for 25-30% of patients, or non-squamous cell carcinoma, accounting for about 70-75% of patients.4-6
The POSEIDON study was a randomized, open-label, multi-centre, global phase III study ofSummarymore platinum-based chemotherapy, orAngst, Stressand chemotherapy versus chemotherapy alone in the first-line treatment of 1013 patients with metastatic NSCLC. The study population included patients with non-squamous or squamous cell disease and the full range of PD-L1 expression levels. POSEIDON excluded patients with certain epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) fusions.
In the experimental arms, patients were treated with a fixed dose of 1500 mgSummary, orSummaryand 75 mg ofImjudowith up to four cycles of chemotherapy every three weeks, followed by maintenance treatment withSummaryonce every four weeks,orSummaryand a fifth dose of 75 mgImjudoadministered at week 16. In comparison, the control arm allowed up to six cycles of chemotherapy. Pemetrexed maintenance therapy was allowed in patients with non-squamous cell disease in all arms when administered during the induction phase. Almost all patients with non-squamous cell disease (95.5%) received pemetrexed and platinum, whereas most patients with squamous cell disease receiving chemotherapy (88.3%) received gemcitabine and platinum.
The primary endpoints included progression-free survival (PFS) and OS for theSummarymore chemotherapy arm. Key secondary endpoints included PFS and OS inSummarymoreImjudoand chemotherapy arm. Since both PFS endpoints have been servedSummaryin addition to chemotherapyAngst, Stressand chemotherapy, the pre-established statistical analysis plan allowed testing of the OS in theSummarymoreImjudoand chemotherapy arm. The study was conducted at more than 150 centers in 18 countries including the US, Europe, South America, Asia and South Africa.
Summary(Durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, combating tumor immune evasion tactics and reversing the inhibition of immune responses .
In addition to its approved indications in lung cancer,Summaryis also the only approved immunotherapy for unresectable or metastatic cholangiocarcinoma and hepatocellular carcinoma (in combination withImjudo) and is also approved in several countries for previously treated patients with advanced bladder cancer.
As part of a broader development programSummaryis being tested as a single treatment and in combination with other cancer treatments for patients with SCLC, NSCLC, bladder cancer, various gastrointestinal cancers, ovarian cancer, endometrial cancer and other solid tumors.
Imjudo(tremelimumab) is a human monoclonal antibody that targets the activity of the cytotoxic T lymphocyte-associated protein 4 (CTLA-4). Imjudo blocks CTLA-4 activity, contributes to T-cell activation, initiates the immune response to cancer, and promotes cancer cell deathH.
Imjudois also permitted in combination withSummaryfor the treatment of inoperable hepatocellular carcinoma (HCC) and is being tested in combination withSummaryin multiple tumor types including locoregional HCC (EMERALD-3), SCLC (ADRIATIC) and bladder cancer (VOLGA and NILE).
AstraZeneca on lung cancer
AstraZeneca works to bring lung cancer patients closer to a cure through early detection and treatment of the disease, while pushing the frontiers of science to improve outcomes in resilient and advanced settings. By defining new therapeutic targets and exploring innovative approaches, the company aims to tailor medicines to those patients who will benefit most.
The company's comprehensive portfolio includes leading lung cancer medicines and the next wave of innovations, includingTagrisso(Osimertinib) eIressa(Gefitinib);Summary(durvalumab) andImjudo(tremelimumabe);stay strong(trastuzumab deruxtecan) and datopotamab deruxtecan in collaboration with Daiichi Sankyo;Orpatien(Savolitinib) in collaboration with HUTCHMED; as well as a range of potential new drugs and combinations through different mechanisms of action.
AstraZeneca is a founding member of the Lung Ambition Alliance, a global coalition working to accelerate innovation and bring meaningful improvements to people with lung cancer, including and beyond treatment.
AstraZeneca in Immuno-Oncology (IO)
AstraZeneca has a comprehensive and diverse portfolio of IO and pipeline anchored immunotherapies designed to overcome evasion of the anti-tumor immune response and stimulate the body's immune system to attack tumors.
AstraZeneca aims to transform cancer care and help improve patient outcomesSummaryas a single treatment and in combination withImjudoas well as other new immunotherapies and modalities. The company is also researching next-generation immunotherapies, such as B. bispecific antibodies and therapeutics that use different aspects of immunity to fight cancer.
AstraZeneca is boldly pursuing an innovative clinical strategy to bring IO-based therapies that enable long-term survival to new settings in a variety of cancer types. With an extensive clinical program, the company also advocates the use of IO treatment in the early stages of the disease where there is greater potential for healing.
AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the goal of offering cures for cancer in all forms, by following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.
The company's focus is on some of the most challenging types of cancer. Through constant innovation, AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to accelerate change in medical practice and transform the patient experience.
AstraZeneca's vision is to redefine cancer treatment and one day eliminate cancer as a killer.
AstraZeneca (LSE/STO/Nasdaq: AZN) is a science-driven global biopharmaceutical company focused on the discovery, development and commercialization of prescription medicines in oncology, orphan diseases and biopharmaceuticals, including cardiovascular, renal and metabolic and respiratory and immunology. Headquartered in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients around the world. please visitastrazeneca.comand follow the company on Twitter @AstraZeneca.
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1. Lung function. lung cancer statistics. Available in:https://www.lungevity.org/for-supporters-advocates/lung-cancer-awareness/lung-cancer-statistics#1. Retrieved November 2022.
2. American Cancer Society. Lung Cancer Survival Rates. Available at: https://www.cancer.org/cancer/lung-cancer/detection-diagnosis-staging/survival-rates.html. Retrieved November 2022.
3. WHO. International Agency for Research on Cancer. Technical data sheet lungs. Available in:https://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf. Retrieved November 2022.
4. Abernethy AP,and other. Real world first-line treatment and overall survival in non-small cell lung cancer without known EGFR mutations or ALK rearrangements in a US oncology setting.Plus one. 2017;12(6):e0178420.
5. Cheema PK,and other. Prospects for treatment advances in locally advanced unresectable stage III non-small cell lung cancer.Curr Oncol. 2019;26(1):37-42.
6. Cancer.net. Lung cancer - non-small cell: introduction. Available at: https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/introduction. Retrieved November 2022.
Is AstraZeneca Imjudo Imfinzi combo approved for non-small cell lung cancer? ›
The FDA approved the combination of durvalumab (Imfinzi, AstraZeneca) and tremelimumab (Imjudo, AstraZeneca) plus platinum-based chemotherapy for the treatment of adult patients with stage IV non-small cell lung cancer (NSCLC).Does chemo work for non-small cell lung cancer? ›
Chemotherapy is a common treatment for non small cell lung cancer. Some people might have chemotherapy before surgery (neo-adjuvant chemotherapy). This can shrink the cancer and make it easier to remove. For early stage NSCLC, chemotherapy after surgery can help to lower the risk of the cancer coming back.What is the most effective treatment for non-small cell lung cancer? ›
If you have stage I NSCLC, surgery may be the only treatment you need. This may be done either by taking out the lobe of the lung that has the tumor (lobectomy) or by taking out a smaller piece of the lung (sleeve resection, segmentectomy, or wedge resection).Does immunotherapy work for non-small cell lung cancer? ›
Immunotherapy is one of the newest treatment options for metastatic non-small-cell lung cancer. It's different from chemotherapy. Instead of attacking cells as they divide, it uses your immune system to kill cancer and stop cancer from growing.What chemo drugs are used for non-small cell lung cancer? ›
- Paclitaxel (Taxol)
- Albumin-bound paclitaxel (nab-paclitaxel, Abraxane)
- Docetaxel (Taxotere)
- Gemcitabine (Gemzar)
- Vinorelbine (Navelbine)
- Etoposide (VP-16)
- Abraxane (Paclitaxel Albumin-stabilized Nanoparticle Formulation)
- Afatinib Dimaleate.
- Afinitor (Everolimus) Afinitor Disperz (Everolimus)
- Alecensa (Alectinib)
- Alimta (Pemetrexed Disodium)
- Alunbrig (Brigatinib)
For regional NSCLC, which means the cancer has spread outside of the lung to nearby lymph nodes, the 5-year survival rate is about 35%. When cancer has spread to distant parts of the body, called metastatic lung cancer, the 5-year survival rate is 7%.What is the best treatment for stage 4 non-small cell lung cancer? ›
Although some patients with Stage IV NSCLC have cancer that has spread to only a single other site that can be treated with surgery or radiation therapy, systemic therapy with chemotherapy or targeted therapy is the mainstay of treatment for most patients with Stage IV NSCLC.What is the life expectancy of someone with non-small cell lung cancer? ›
|SEER stage||5-year relative survival rate|
|All SEER stages combined||26%|
Complete remission of advanced NSCLC can be achieved using the combination of oral icotinib and BAI chemotherapy. Core tip: Few patients can undergo surgery for treatment of non-small-cell lung cancer because of advanced disease or poor pulmonary function.
Which is worse small cell lung cancer non-small cell lung cancer? ›
Small cell lung cancer (SCLC)
This type of lung cancer tends to grow and spread faster than NSCLC. In most people with SCLC, the cancer has already spread beyond the lungs at the time it is diagnosed. Since this cancer grows quickly, it tends to respond well to chemotherapy and radiation therapy.
Once cancer cells get into the blood, the cancer can spread anywhere in the body. But, NSCLC is more likely to spread to the brain, bones, liver, and adrenal glands.How treatable is non-small cell lung cancer? ›
Yes. Non-small cell lung cancer is curable, especially with early detection and treatment. Certain factors can affect your overall prognosis, such as: The stage of the cancer (the size of the tumor and whether it is only in your lung or has spread to other places in your body).What is the best treatment for metastatic lung cancer? ›
Most of the time, surgery won't work for advanced lung cancer because it has spread. Most people with the disease can have treatment with a mix of radiation, chemotherapy, and targeted therapies -- drugs that attack specific parts of the cancer cells.What chemo is used for metastatic lung cancer? ›
NSCLC chemotherapy usually includes a combination of cisplatin and carboplatin plus either docetaxel (Taxotere), gemcitabine (Gemzar), paclitaxel (Taxol), pemetrexed (Alimta), or vinorelbine (Navelbine).What is the new lung cancer treatment for 2022? ›
On August 11, 2022, the FDA also approved T-DXd for non-small cell lung cancers caused by mutations in the HER2 gene. The trial that resulted in the approval was led by MSK medical oncologist Bob Li, MD, PhD, MPH.What stage is metastatic non-small cell lung cancer? ›
Non-small cell lung cancer stage 4
NSCLC stages, which range from stage 1 to stage 4, are determined based on several factors, including the main lung tumor's size and whether the cancer has spread to lymph nodes near the lungs or metastasized farther away in the body.
The study found that the average life expectancy of someone with SCLC that has metastasized to the liver is around 3 months. This was shorter for people with metastasis to the brain or bone, who lived for around 5–7 months.What does metastatic non-small cell lung cancer mean? ›
Non-small-cell lung cancer (NSCLC) is the most common kind of lung cancer, making up about 80 to 85 percent of all cases, according to the American Cancer Society (ACS). It's referred to as metastatic NSCLC when it has spread from the lungs to other parts of the body.Can you survive stage 4 non-small cell lung cancer? ›
Stage 4 is the most advanced form of non-small cell lung cancer. While this means it's difficult to treat and survival rates are low — around 8% — these estimates can't predict your individual situation.
Can Stage 4 lung cancer be cured with immunotherapy? ›
Immunotherapy is a lung cancer treatment. It does not cure stage 4 lung cancer, but it may help patients live longer.Is Stage 4 non-small cell lung cancer curable? ›
Stage IV lung cancer cannot be cured. However, early integration of palliative care (also called "comfort care") into the treatment of advanced non-small cell lung cancer (NSCLC) may improve quality of life. This can include assessment of physical and psychological needs and the goals for care.How often does non-small cell lung cancer come back? ›
In fact, 30% to 55% of patients with NSCLC develop recurrence and die of their disease despite curative resection (3-5). Therefore, many patients eventually die of their disease due to recurrence after surgery (6,7). Furthermore, surgery itself possesses a certain amount of risk (8,9).Is non-small cell lung cancer a fast growing cancer? ›
Non-small cell lung cancer is the most common type of lung cancer. It grows and spreads more slowly than small cell lung cancer.What is the survival rate for stage 2 non-small cell lung cancer? ›
Stage 2 lung cancer survival rate
According to the National Cancer Institute, the five-year survival rate for treated stage 2 non-small cell lung cancer is 35 percent. This means about 35 out of 100 patients are expected to be alive five years after treatment.
Life expectancy for people with metastatic lung cancer is low. The overall 5-year survival rate for small cell lung cancer is 3%, and 8% for non-small cell lung cancer (NSCLC). 25-30% of people with metastatic NSCLC have a life expectancy of under 3 months.How long do you live when cancer spreads to lymph nodes? ›
A patient with widespread metastasis or with metastasis to the lymph nodes has a life expectancy of less than six weeks. A patient with metastasis to the brain has a more variable life expectancy (one to 16 months) depending on the number and location of lesions and the specifics of treatment.What is the survival rate of non-small cell lung cancer stage 3A? ›
According to the American Cancer Society data derived from a database of people diagnosed with lung cancer between 1999 and 2010, the five-year survival rate for stage 3A NSCLC is about 36 percent. For stage 3B cancers the survival rate is about 26 percent. For stage 3C cancers the survival rate is about 1 percent.Is Imfinzi FDA approved? ›
On September 2, 2022, FDA approved durvalumab (brand name Imfinzi) in combination with gemcitabine and cisplatin for adult patients with locally advanced or metastatic biliary tract cancer.What is Imfinzi approved for? ›
Imfinzi is approved in the US and several other countries in combination with chemotherapy for the treatment of locally advanced or metastatic biliary tract cancer based on the TOPAZ-1 Phase III trial, and it is approved with Imjudo in the US for the treatment of unresectable hepatocellular carcinoma based on the ...
Is durvalumab approved for NSCLC? ›
On November 10, 2022, the Food and Drug Administration approved tremelimumab (Imjudo, AstraZeneca Pharmaceuticals) in combination with durvalumab (Imfinzi, AstraZeneca Pharmaceuticals) and platinum-based chemotherapy for adult patients with metastatic non-small cell lung cancer (NSCLC) with no sensitizing epidermal ...What is the newest treatment for small cell lung cancer? ›
A promising new treatment option for SCLC is targeted therapy. Targeted therapy works by attacking specific cancer cells or blocking certain molecules that develop into cancer with minimal to no harm to normal cells.Does Medicare pay for Imfinzi? ›
No. In general, Medicare prescription drug plans (Part D) do not cover this drug.What is the success rate of Imfinzi? ›
With IMFINZI, 43% of patients were still alive at the 5-year landmark.How long can you take Imfinzi? ›
Patients will receive IMFINZI every 2 weeks or every 4 weeks for up to 12 months or until the disease has worsened or side effects become intolerable. Your doctor will decide how long you will receive IMFINZI and how many treatments you need.Is Imfinzi chemotherapy or immunotherapy? ›
IMFINZI is an immunotherapy—not chemotherapy. That means it works with the immune system to find and attack cancer. IMFINZI may also attack healthy cells. If chemoradiation therapy (CRT) has worked for you, IMFINZI may be your next step.
Imfinzi contains the active ingredient durvalumab. Keytruda contains a different active ingredient, pembrolizumab.What is the cost of Imfinzi? ›
The cost for Imfinzi intravenous solution (50 mg/mL) is around $993 for a supply of 2.4 milliliters, depending on the pharmacy you visit. Quoted prices are for cash-paying customers and are not valid with insurance plans.Can immunotherapy shrink lung tumors? ›
The sad truth about immunotherapy treatment in lung cancer is that it shrinks tumors in only about 1 or 2 out of 10 patients, explains Roy Herbst, MD, PhD, Yale Medicine's chief of medical oncology. This means that about 80 percent of NSCLC lung patients still need more treatment options.Who treats metastatic NSCLC? ›
A medical oncologist: a doctor who treats cancer with medicines such as chemotherapy, targeted therapy, and immunotherapy.
How successful is durvalumab? ›
These updated exploratory analyses demonstrate durable PFS and sustained OS benefit with durvalumab after chemoradiotherapy. An estimated 49.6% of patients randomized to durvalumab remain alive at 4 years (placebo, 36.3%), and 35.3% remain alive and progression-free (placebo, 19.5%).What is the new breakthrough in lung cancer? ›
Scientists investigating the mechanics of the early stages of lung cancer have identified a new potential treatment, which could also aid early detection of the disease. Levels of a key protein – called TLR2 – in tumors was found to predict a patient's survival after being diagnosed with lung cancer, a study shows.What are the new treatments for lung cancer 2023? ›
FDA Approves Adjuvant Pembrolizumab for Stage IB-IIIA NSCLC
On January 26, 2023, the FDA approved the use of adjuvant pembrolizumab (Keytruda) after the resection and platinum-based chemotherapy for stage IB (T2a ≥4 cm), II, or IIIA NSCLC.
On August 11, 2022, the FDA also approved T-DXd for non-small cell lung cancers caused by mutations in the HER2 gene. The trial that resulted in the approval was led by MSK medical oncologist Bob Li, MD, PhD, MPH.