September 1, 2020 07:00 BST
Only PD-1/PD-L1 immunotherapy has shown a significant survival benefit and improved response rate in combination with a selection of chemotherapies.
es AstraZenecaSummary(durvalumab) is approved in the European Union for the first-line treatment of adults with extended-stage small cell lung cancer (ES-SCLC) in combination with selected chemotherapies, etoposide plus carboplatin or cisplatin.
SCLC is a highly aggressive, fast-growing form of lung cancer that often recurs and progresses rapidly despite an initial response to chemotherapy.1,2
The approval of the European Commission was based on the positive results of the CASPIAN Phase III study showingSummaryplus chemotherapy demonstrated a statistically and clinically significant overall survival (OS) benefit for first-line treatment of patients with ES-SCLC. Follow therecommendation for approvalby the Committee for Medicinal Products for Human Use of the European Medicines Agency in July 2020.
Luis Paz-Ares MD, Ph.D., Head of the Department of Medical Oncology, Hospital Universitario Doce de Octubre, Madrid, Spain and principal investigator of the Phase III CASPIAN study, said: "For the first time, patients with extensive disease Small cell stage lung cancer in Europe will have the option of combination immunotherapy with cisplatin, a chemotherapy preferred by many European physicians in this setting.SummaryIt provides clinicians with an important new first-line treatment option that provides significant overall survival benefit with well-tolerated treatment.”
Dave Fredrickson, executive vice president of the oncology business unit, said: “SummaryFurthermore, chemotherapy is becoming a new global standard of care for patients with long-stage small cell lung cancer, and we are pleased to offer this option to patients in Europe who urgently need it. This is the first immunotherapy regimen to offer a sustained survival benefit and improved response rate, as well as a choice of chemotherapies and convenient dosing every four weeks during maintenance."
The CASPIAN study met the primary endpoint of OS forSummaryplus chemotherapy in June 2019, which reduced the risk of death by 27% compared with chemotherapy alone (based on a hazard ratio [HR] of 0.73; 95% confidence interval [CI]: 0.59-0.91, p = 0.0047), with a median OS of 13.0 months versus 10.3 months for chemotherapy alone. These results were published inthe lancetem 2019.3The results also showed an increase in the confirmed objective response rate forSummaryplus chemotherapy (68% vs. 58% for chemotherapy alone) and whoSummaryadded to chemotherapy delayed the time for symptoms of the disease to worsen.
An updated analysisrecently showed sustained efficacy forSummaryplus chemotherapy after a median follow-up of more than two years (OSHR: 0.75; 95% CI: 0.62-0.91; nominal p=0.0032), with a median OS of 12.9 months vs. 10.5 months for chemotherapy alone. The safety and tolerability ofSummaryplus chemotherapy were consistent with the known safety profile of these drugs. No patient tested positive for treatment-emergent anti-drug antibodies forSummary.
The CASPIAN study used a fixed dose ofSummary(1500 mg) given every three weeks for four cycles in combination with chemotherapy and then every four weeks until disease progression.
Summaryin combination with etoposide and carboplatin or cisplatin is also approved in the US, Japan, and several other countries for the treatment of ES-SCLC in a first-line setting and is currently under regulatory review in other countries.
As part of a broader development program,Summaryit is also being tested after concomitant chemoradiotherapy in patients with limited-stage SCLC in the phase III ADRIATIC trial.
small cell lung cancer
Lung cancer is the leading cause of cancer death among men and women, accounting for approximately one fifth of all cancer deaths.4Lung cancer is broadly divided into non-small cell lung cancer (NSCLC) and SCLC, with about 15% classified as SCLC.5About two-thirds of SCLC patients are diagnosed with ES-SCLC, in which cancer has spread widely through the lung or to other parts of the body.6The prognosis is particularly poor, as only 6% of all SCLC patients will be alive five years after diagnosis.6
CASPIAN was a phase III global, multicenter, open-label, randomized trial in the first-line treatment of 805 patients with ES-SCLC. The trial comparedSummaryin combination with etoposide and chemotherapy with carboplatin or cisplatin, orSummaryand chemotherapy with the addition of a second immunotherapy, tremelimumab, versus chemotherapy alone. In the experimental arms, patients were treated with four cycles of chemotherapy. By comparison, the control group allowed up to six cycles of chemotherapy and optional prophylactic cranial irradiation. The study was conducted at more than 200 centers in 23 countries, including the US, in Europe, South America, Asia, and the Middle East. The primary endpoint was OS in each of the two experimental arms. In June 2019, AstraZeneca announced that the CASPIAN study had reached a demonstration end point of the main operating system forSummaryplus chemotherapy at a planned interim analysis. In March 2020, it was announced that the second trial group with tremelimumab did not meet its primary OS endpoint.
Summaryis a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, combating tumor immune evasion tactics and releasing inhibition of immune responses.
Summaryis approved in the setting of curative intent for unresectable stage III NSCLC after chemoradiotherapy in the US, Japan, China, the entire EU, and many other countries, based on results from the phase III PACIFIC trial.Summaryit is also approved for previously treated patients with advanced bladder cancer in the United States and a small number of other countries.
As part of a broader development program,Summaryit is also being tested as monotherapy and in combination, including with tremelimumab, an anti-CTLA4 monoclonal antibody and potential new drug, as a treatment for patients with NSCLC, SCLC, bladder cancer, head and neck cancer, liver cancer, breast cancer, urinary tract biliary breast, cervical cancer, ovarian cancer, endometrial cancer and other solid tumors.
AstraZeneca on lung cancer
AstraZeneca has a comprehensive portfolio of approved and potential new medicines in advanced stages of development for the treatment of different forms of lung cancer spanning different histologies, various disease stages, lines of therapy and modes of action.
A large immuno-oncology (IO) development program focuses on lung cancer patients without a specific gene mutation, who account for up to three-quarters of all lung cancer patients.7 Summary, an anti-PDL1 antibody, is in development for patients with advanced disease (POSEIDON and PEARL phase III trials) and for patients in early stages of the disease, including potentially curative scenarios (MERMAID-1, AEGEAN, ADJUVANT phase III trials BR 31, PACIFIC-2, PACIFIC-4, PACIFIC-5, and ADRIATIC) either as monotherapy or in combination with tremelimumab and/or chemotherapy.Summaryis also under development in NeoCOAST, COAST, and HUDSON Phase II trials in combination with potential new drugs from the early-stage pipeline, includingstay strong.
AstraZeneca's approach to IoT
IO is a therapeutic approach designed to stimulate the body's immune system to attack tumors. The company's IO portfolio is anchored in immunotherapies that are designed to overcome antitumor immune suppression. AstraZeneca is investing in the use of IO approaches that provide long-term survival for new groups of patients across all tumor types.
The company is developing a comprehensive clinical trial program that includesSummaryas monotherapy and in combination with tremelimumab in multiple tumor types, disease stages, and lines of therapy and, where relevant, using the PD-L1 biomarker as a decision-making tool to define the best potential treatment pathway for a patient. Furthermore, the ability to combine the IO portfolio with radiation, chemotherapy, small molecule targets from AstraZeneca's oncology portfolio and research partners could provide new treatment options for a wide range of tumors.
AstraZeneca in oncology
AstraZeneca has a deep-rooted heritage in oncology and offers a growing portfolio of new medicines with the potential to transform the lives of patients and the future of the company. With seven new medicines launched between 2014 and 2020 and a broad line of biologics and small molecule products in development, the company is committed to advancing oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood. .
By harnessing the power of four scientific platforms—immuno-oncology, tumor drivers and resistance, DNA damage response, and drug-antibody conjugates—and by championing the development of personalized combinations, AstraZeneca has a vision to redefine cancer care and, eventually, day, eliminate cancer as a cause of death.
AstraZeneca (LSE/STO/NYSE: AZN) is a global science-driven biopharmaceutical company focused on the discovery, development and commercialization of prescription medicines primarily for the treatment of diseases in three therapeutic areas: Oncology, Cardiovascular, Renal and Metabolism, and Respiratory. and Immunology. Headquartered in Cambridge, UK, AstraZeneca operates in more than 100 countries and its innovative medicines are used by millions of patients around the world. please visitastrazeneca.comand follow the Company on Twitter@AstraZeneca.
For details on how to contact the Investor Relations Team, clickhere. For media contacts, clickhere.
1. National Cancer Institute. NCI Dictionary: Small Cell Lung Cancer. Availablehttps://www.cancer.gov/publications/dictionaries/cancer-terms/def/small-cell-lung-cancer. Consulted in July 2020.
2. GP Kalemkerian,and another. Treatment options for recurrent small cell lung cancer: what progress have we made?Oncology Practice Journal, 2018:14;369-370.
3. Paz-Ares L,and anotherDurvalumab plus platinum etoposide versus platinum etoposide in the first-line treatment of extended-stage small cell lung cancer (CASPIAN): an open-label, randomized, controlled phase 3 study.the lancet. 2019;394(10212):1929-1939.
4. World Health Organization. International Agency for Research on Cancer. Lung Technical Sheet. Availablehttp://gco.iarc.fr/today/data/factsheets/cancers/15-Lung-fact-sheet.pdf. Consulted in July 2020.
5. LUNGevity Foundation. Types of lung cancer. Availablehttps://lungevity.org/for-patients-caregivers/lung-cancer-101/types-of-lung-cancer. Consulted in July 2020.
6. Cancer.Net. Small cell lung cancer. Availablehttps://www.cancer.net/cancer-types/33776/view-all. Consulted in July 2020.
7. Pakkala, S,and anotherPersonalized therapy for lung cancer: hitting the moving target.JCI Perspective. 2018;3(15):e120858.
Is Imfinzi approved in EU? ›
AstraZeneca's Imfinzi (durvalumab) has been approved in the European Union (EU) for the 1st-line treatment of adult patients with unresectable or metastatic biliary tract cancer (BTC) in combination with chemotherapy (gemcitabine plus cisplatin).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 ...When was Imfinzi approved for SCLC? ›
Development timeline for Imfinzi.
|Mar 30, 2020||Approval Imfinzi (durvalumab) Approved in the US for Extensive-Stage Small Cell Lung Cancer|
Immunotherapy is a newer form of treatment for stage 3 lung cancer, but it's showing promise as an effective solution for dealing with this disease. While it isn't right for everyone, immunotherapy may allow you to use your own body to help fight your cancer.What is the difference between Keytruda and Imfinzi? ›
Imfinzi contains the active ingredient durvalumab. Keytruda contains a different active ingredient, pembrolizumab.What is the success rate of Imfinzi? ›
With IMFINZI, 43% of patients were still alive at the 5-year landmark.Does Medicare pay for Imfinzi? ›
No. In general, Medicare prescription drug plans (Part D) do not cover this drug.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.
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.Can immunotherapy cure SCLC? ›
Immunotherapy drugs called checkpoint inhibitors have given many lung cancer patients a lifesaving new option. But patients with small cell lung cancer have seen little benefit from the new paradigm.
Does Imfinzi work for SCLC? ›
Imfinzi is approved for the 1st-line treatment of ES-SCLC in combination with SoC chemotherapy in the US and Singapore. Imfinzi is also approved for previously treated patients with advanced bladder cancer in the US and a small number of other countries.How much does durvalumab cost? ›
Though stage 3 lung cancer is generally not considered curable, it is treatable. With the development of new and promising lung cancer treatments, more people may have a chance of achieving remission than ever before.How long can you survive lung cancer with immunotherapy? ›
In her study, 70% of the patients who were able to complete 2 years on the chemo-immunotherapy combination were still alive at five years. They get infusions every three weeks for those two years, but most can work during treatment. "The quality of life of these patients is quite high," Garassino said.Can you fully recover from Stage 3 lung cancer? ›
Summary. Currently, there is no cure for stage 3 lung cancers, but treatment can often help prolong life and relieve symptoms. In some cases, a person with stage 3 lung cancer may survive another 5 years or longer .Is there a generic Imfinzi? ›
Durvalumab is the generic name for the trade name drug, Imfinzi. In some cases, health care professionals may use the trade name, Imfinzi, when referring to the generic drug name, durvalumab.How long can you be on durvalumab? ›
You usually have durvalumab every 2 weeks. It takes about an hour each time you have it. You have durvalumab for as long as it works and the side effects are not too bad. You usually have it for up to a year.What happens if you stop immunotherapy? ›
Data suggest that stopping immunotherapy after 1 year of treatment could lead to inferior progression-free survival and overall survival, says Lopes. However, stopping after 2 years does not appear to negatively impact survival.How much longer can you live with immunotherapy? ›
A study conducted by UCLA researchers involving patients with non-small cell lung cancer (NSCLC) found that the immunotherapy drug pembrolizumab increased the average 5-year survival rate of these patients from 5.5% to 15%.What is the survival rate after immunotherapy? ›
⁶ Of the trial participants who received the combination therapy, 49% were still alive after six and a half years, with 34% experiencing progression-free survival. The median survival for those who received combination therapy was 72.1 months. 1.
Can immunotherapy help you live longer? ›
Patients receiving the immunotherapy drug combination had a median overall survival of 14.5 months, compared with 11.6 months for patients receiving standard of care therapy.Do insurance companies cover immunotherapy? ›
Do health insurance plans pay for immunotherapy? Many private insurance plans, including Medicare Advantage plans, cover cancer immunotherapy. So does Medicare. These plans also may cover other types of immunotherapy.Is immunotherapy covered under Medicare Part B? ›
If you receive immunotherapy as an inpatient, the hospital costs related to your immunotherapy are typically covered by Medicare Part A (Hospital Insurance). If you receive immunotherapy as an outpatient, your doctor's services are covered by Medicare Part B (Medical Insurance).What diagnosis is covered by IMFINZI? ›
IMFINZI is indicated for the treatment of patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.Which cancers are best treated with immunotherapy? ›
- Mesothelioma. ...
- Multiple myeloma. ...
- Non-Hodgkin lymphoma. ...
- Prostate cancer. ...
- Skin cancer. ...
- Soft tissue sarcoma. ...
- Stomach cancer. ...
- Endometrial cancer. For some patients with advanced uterine cancer, treatment with checkpoint inhibitors may be an option:
Both immunotherapy and chemotherapy can be effective cancer treatments. One is not better than the other. The effectiveness of each treatment depends on the type and stage of cancer a person has.Is immunotherapy less harsh than chemotherapy? ›
Immunotherapy, in general, is less toxic than chemotherapy for patients with cancer. However, the side effects [adverse events (AE)] linked to these new treatments [treatment-related adverse events (trAEs)] are often described and have variable severity (6).Can you stay on immunotherapy indefinitely? ›
Currently, there's no designated end to immunotherapy treatment. You may continue on the regimen as long as you continue to have a good response. Patients sometimes ask to take a break from treatment.What is the overall survival with durvalumab after? ›
Updated OS and PFS remained consistent with the primary analyses; of patients randomly assigned to durvalumab, an estimated 42.9% remain alive at 5 years and 33.1% remain alive and progression-free.How many patients are on IMFINZI? ›
Imfinzi is approved in the curative-intent setting of unresectable, Stage III NSCLC after CRT in the US, Japan, China, across the EU and in many other countries. Since the first approval in February 2018, more than 80,000 patients in this setting have been treated with Imfinzi.
How long does SCLC stay in remission? ›
However, remission lasts less than a year in most cases. Few cases are cured. Some doctors consider your cancer cured if your remission last more than 5 years . In a 2020 study, researchers found that more than 90 percent of cases of small-cell lung cancer came back within 2 years.Can extensive SCLC go into remission? ›
If left untreated, patients with SCLC rarely survive longer than a few months 5, but chemotherapy dramatically prolongs survival compared to the best supportive care 6. For patients with ES-SCLC, 60–80% respond to chemotherapy, although complete remission is observed in only 15–20%.Can small cell carcinoma go into remission? ›
SCLC exhibits faster disease progression and poorer prognosis than other types of lung cancer. SCLC is highly sensitive to initial chemotherapy and radiation therapy, but most patients eventually die of recurrent disease. Here, we report a rare case of complete spontaneous remission in an elderly patient with SCLC.Does Imfinzi cause hair loss? ›
IMFINZI can cause serious side effects (see above):
The most common side effects of IMFINZI when used with other anticancer medicines in people with ES-SCLC include nausea, hair loss, and feeling tired or weak. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
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%).Which has better prognosis SCLC or NSCLC? ›
The outlook for NSCLC is better than SCLC. Most people find out they have SCLC when it's already spread to other parts of their body. Early detection helps, but it's often found late because you may not have symptoms. With SCLC, the 5-year survival rate is less than 5%.Does durvalumab shrink tumors? ›
Research has shown that durvalumab can slow tumor growth and shrink tumors in some people with cancer. Previous studies of combining durvalumab and chemotherapy showed that this combination is active in advanced mesothelioma.How long does it take to see results from immunotherapy? ›
Many people stay on immunotherapy for up to two years. Checkpoint inhibitors can take weeks or months to start working, depending on how your immune system and the cancer respond. Most cancers have treatment protocols that set out which drugs to have, how much and how often.Does durvalumab make tired? ›
THE MOST COMMON SIDE EFFECTS OF IMFINZI IN PEOPLE WITH UNRESECTABLE STAGE 3 NSCLC INCLUDE: Cough. Feeling tired. Inflammation in the lungs.Is Amivantamab approved in Europe? ›
Amivantamab is the first approved treatment in the European Union specifically targeting EGFR exon 20 insertion mutations for NSCLC.
Is durvalumab approved? ›
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 ...Who manufactures Imfinzi? ›
|Christer Gruvris||Autoimmunity, neuroscience & infection||+44 203 749 5711|
|US Toll-Free||+1 866 381 7277|
Currently the compound is only available in Canada and the US or for those involved in the trial being carried out by Amylyx. The Phase 3 PHOENIX study is currently the only route to access AMX0035 in Europe.Does Europe have an FDA equivalent? ›
European Medicines Agency (EMA) : EMA is a decentralized body of the European Union, located in Amsterdam in the Netherlands. It is responsible for the scientific evaluation, supervision, and safety monitoring of medicines for human and veterinary use in the EU.How new drugs are approved in Europe? ›
The European Commission is the authorising body for all centrally authorised product, who takes a legally binding decision based on EMA's recommendation. This decision is issued within 67 days of receipt of EMA's recommendation.What cancers is immunotherapy approved for? ›
- Bladder Cancer. The first FDA-approved immunotherapy treatment—Bacillus Calmette-Guérin cancer vaccine—was for bladder cancer in 1990.
- Brain Cancer. ...
- Breast Cancer. ...
- Cervical Cancer. ...
- Childhood Cancer. ...
- Colorectal Cancer. ...
- Esophageal Cancer. ...
- Head and Neck Cancer.
IMFINZI can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. You can have more than one of these problems at the same time.What drug class is Imfinzi? ›
Imfinzi belongs to a class of drugs called PD-1/PD-L1 Inhibitors.