Durvalumab
- Generic Name
- Durvalumab
- Brand Names
- Imfinzi
- Drug Type
- Biotech
- CAS Number
- 1428935-60-7
- Unique Ingredient Identifier
- 28X28X9OKV
- Background
Durvalumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody and a novel immune-checkpoint inhibitor for cancer treatment. Produced by recombinant DNA technology in Chinese Hamster Ovary (CHO) cell suspension culture, durvalumab is a programmed death-ligand 1 (PD-L1) blocking antibody that works to promote normal immune responses that attack tumour cells.
Durvalumab is marketed under the brand name Imfinzi, which is available for intravenous injections. It was granted accelerated approval by the FDA in May 2017 for the treatment of selected patients with locally advanced or metastatic urothelial carcinoma. In September 2018, durvalumab was approved by the EMA for the treatment of adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC), only if PD-L1 is expressed in ≥ 1% of tumour cells and there was no observable disease progression following platinum-based chemoradiation therapy. On March 27, 2020, durvalumab was approved by the FDA for use in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC).
- Indication
Durvalumab is indicated for the treatment of adults with the following conditions:
- Associated Conditions
- Extensive-stage Small Cell Lung Cancer (SCLC), Locally Advanced Biliary Tract Cancer, Metastatic Biliary Tract Cancer, Metastatic Non-Small Cell Lung Cancer, Unresectable Hepatocellular Carcinoma (HCC), Unresectable Stage III Non-small Cell Lung Cancer, Unresectable, locally advanced PD-L1 positive Lung Cancer Non-Small Cell Cancer (NSCLC)
- Associated Therapies
- First Line Chemotherapy
AstraZeneca Showcases Groundbreaking Cancer Research at ASCO 2025 with Two Plenary Presentations
• AstraZeneca will present over 80 abstracts at ASCO 2025, including two plenary presentations featuring camizestrant for HR-positive breast cancer and IMFINZI for early gastric cancer, marking their seventh consecutive year with plenary data.
• The SERENA-6 trial is the first positive Phase III study for a next-generation oral SERD in first-line HR-positive breast cancer, pioneering the use of circulating tumor DNA to guide treatment decisions.
• DESTINY-Breast09 data shows ENHERTU plus pertuzumab is the first treatment in over a decade to demonstrate superiority over standard care in first-line HER2-positive metastatic breast cancer.
Takeda Spotlights Three Late-Stage Readouts as Potential "Inflection Point" Amid Vyvanse Generic Competition
• Takeda Pharmaceutical is positioning three upcoming late-stage clinical trial readouts as a strategic "inflection point" to offset revenue losses from Vyvanse's generic competition.
• The Japanese pharmaceutical giant is focusing on new product launches and pipeline advancement to maintain growth momentum, with particular emphasis on rare disease and neuroscience therapeutic areas.
• Industry analysts view Takeda's pipeline strategy as critical for the company's long-term financial stability, as it navigates the challenging transition period of losing exclusivity for one of its top-selling medications.
FDA to Deploy AI Assistant Across All Centers by June 30 to Accelerate Scientific Reviews
• FDA Commissioner Martin Makary announced an agency-wide rollout of AI tools to assist with scientific reviews across all 11 FDA centers, with full deployment expected by June 30, 2025.
• The AI assistant aims to handle repetitive aspects of regulatory reviews, allowing FDA scientists to focus on critical safety evaluations while potentially accelerating approval timelines for new therapies.
• Implementation will be led by FDA's Chief AI Officer Jeremy Walsh and CDER's Strategic Programs Director Sridhar Mantha, with transparency measures including public release of user feedback and performance results.
AstraZeneca's Breztri Shows Significant Improvement in Phase III Asthma Trials
• Breztri Aerosphere met all primary endpoints in KALOS and LOGOS Phase III trials, demonstrating statistically significant improvement in lung function for patients with uncontrolled asthma compared to dual-combination therapies.
• The triple-combination therapy (budesonide/glycopyrronium/formoterol fumarate) could potentially address a critical unmet need, as nearly half of asthma patients on dual therapy remain uncontrolled.
• AstraZeneca plans to share the full trial results with regulatory authorities, potentially expanding Breztri's approved indications beyond its current use in COPD treatment across 80+ countries.
FDA Approves AstraZeneca's Imfinzi for Perioperative Treatment of Muscle-Invasive Bladder Cancer
• AstraZeneca's Imfinzi (durvalumab) has received FDA approval for perioperative treatment of muscle-invasive bladder cancer (MIBC), marking a significant advancement in the standard of care for this aggressive cancer type.
• The approval is based on clinical trial data demonstrating Imfinzi's efficacy in improving pathological complete response rates and disease-free survival compared to standard chemotherapy alone in MIBC patients.
• This regulatory milestone positions AstraZeneca at the forefront of bladder cancer treatment innovation, addressing a critical unmet need in the perioperative management of MIBC patients.
AstraZeneca Exits Neuroscience Research to Focus on Core Therapeutic Areas
• AstraZeneca has officially closed its neuroscience research group, discontinuing programs for Alzheimer's disease, migraine, and pain conditions to redirect resources toward higher-value projects.
• The strategic shift allows the pharmaceutical giant to concentrate on its core therapeutic areas including oncology, cardiovascular, respiratory diseases, weight management, and immunology.
• Despite recording 10% revenue growth in Q1 2025 with nearly $13.6 billion in sales, AstraZeneca executives emphasized they "cannot be everywhere," stating CNS research is "better managed by other companies."
BMS's Opdualag Shows Strong Early Performance as First LAG-3 Checkpoint Inhibitor for Melanoma
• Bristol-Myers Squibb's Opdualag, the first FDA-approved LAG-3 inhibitor combination, generated $58 million in second-quarter sales following its March approval for metastatic melanoma.
• Clinical data shows Opdualag more than doubles progression-free survival compared to PD-1 monotherapy, positioning it as a potential new standard of care with anticipated EU approval in coming weeks.
• BMS expects Opdualag to reach $4 billion in peak sales across multiple cancer indications, strengthening its immuno-oncology portfolio as competitors including Merck develop rival LAG-3 inhibitors.
FDA Approves BMS's Opdivo/Yervoy Combination for First-Line Treatment of Advanced Liver Cancer
• Bristol-Myers Squibb's Opdivo (nivolumab) and Yervoy (ipilimumab) combination has received FDA approval for first-line treatment of unresectable or metastatic hepatocellular carcinoma, demonstrating a 21% reduced risk of death compared to standard therapies.
• The CheckMate-9DW trial showed significant survival benefits with a median overall survival of 23.7 months for the immunotherapy combination versus 20.6 months for tyrosine kinase inhibitors, potentially establishing a new standard of care.
• This approval marks a significant advancement for HCC patients, addressing an unmet need in a disease whose incidence has tripled over four decades, though treatment decisions may be influenced by the combination's known toxicity profile.
CDMO Market Report: Key Regulatory Approvals and Clinical Advances in March-April 2025
• Multiple CDMOs secured significant contract manufacturing opportunities as regulatory bodies approved new indications for established drugs, particularly in oncology and rare diseases.
• AstraZeneca's portfolio saw substantial growth with expanded approvals for Imfinzi, Tagrisso, and Lynparza, strengthening partnerships with contract manufacturers including Lonza, Dottikon, and Samsung Biologics.
• Contract manufacturers supporting treatments for autoimmune conditions showed strong performance, with Argenx's Vyvgart Hytrulo receiving expanded indications for myasthenia gravis and CIDP.
Immunotherapy in Gastric Cancer: Moving to Earlier Disease Stages and Optimizing Combination Approaches
• Leading oncologist Dr. Yelena Janjigian emphasizes the need to advance immunotherapy to earlier disease stages in gastric, GEJ, and esophageal cancers, with promising data expected from the MATTERHORN study.
• Recent evidence from phase 3 trials TOPGEAR and ESOPEC demonstrates that radiation therapy does not improve survival outcomes in gastric/GEJ cancers, challenging conventional treatment approaches.
• FLOT chemotherapy regimen combined with durvalumab represents an optimal treatment strategy for the perioperative setting, addressing the systemic nature of gastric cancer rather than focusing on localized radiation therapy.
Study Reveals Factors Influencing Immune Checkpoint Inhibitor Efficacy in Metastatic Colorectal Cancer
• Cleveland Clinic and Moffitt Cancer Center researchers analyzed data from nearly 19,000 metastatic colorectal cancer patients, confirming immune checkpoint inhibitors significantly improve survival in MSI-H tumors compared to chemotherapy alone.
• The study identified specific factors that may enhance immune checkpoint inhibitor efficacy in traditionally unresponsive MSS tumors, including high albumin levels and recent antibiotic use, potentially expanding treatment options.
• Approximately 12.3% of patients with MSS tumors achieved durable responses to immune checkpoint inhibitors, suggesting the need for further research to identify biomarkers that could predict treatment success in this population.
PADCEV-KEYTRUDA Combination Shows Sustained Survival Benefit in Advanced Urothelial Cancer Trial
• Phase 3 EV-302 trial demonstrates PADCEV plus KEYTRUDA reduces mortality risk by 49% compared to chemotherapy in advanced urothelial cancer patients, with median overall survival of 33.8 months versus 15.9 months.
• The combination therapy showed significant progression-free survival benefit of 12.5 months compared to 6.3 months with chemotherapy, representing a 52% reduction in disease progression risk.
• Extended 12-month follow-up data confirms sustained efficacy across all patient subgroups, including both cisplatin eligible and ineligible patients, with no new safety concerns identified.
Acalabrutinib Receives FDA Approval for Previously Untreated Mantle Cell Lymphoma
• The FDA has granted traditional approval to acalabrutinib in combination with bendamustine and rituximab for untreated MCL patients ineligible for stem cell transplant.
• The approval was based on the ECHO trial, which showed a 27% reduction in disease progression or death compared to chemoimmunotherapy alone.
• Median progression-free survival was 66.4 months with acalabrutinib versus 49.6 months with chemoimmunotherapy, demonstrating a clinically significant improvement.
• Acalabrutinib is now the first and only BTK inhibitor approved for first-line MCL treatment, offering a new option for this rare and aggressive cancer.
BMS's Opdivo/Yervoy Combo Shows Survival Benefit in First-line Liver Cancer Treatment
Bristol-Myers Squibb's immunotherapy combination of Opdivo and Yervoy has demonstrated superior survival benefits in first-line hepatocellular carcinoma treatment, with FDA decision expected by April 2024. The therapy showed a 36% objective response rate compared to 13% for standard treatments, potentially offering a new option for patients with unresectable liver cancer.
Pfizer's Sasanlimab Plus BCG Shows Promise in BCG-Naive, High-Risk NMIBC
• Pfizer's Phase 3 CREST trial showed that sasanlimab combined with BCG significantly improved event-free survival in BCG-naive, high-risk NMIBC patients.
• The combination therapy demonstrated a clinically meaningful and statistically significant improvement compared to BCG alone in the study.
• Sasanlimab's safety profile in combination with BCG was consistent with the known profiles of both agents, according to the trial data.
• Pfizer plans to submit the CREST trial results for presentation at an upcoming medical congress and discuss potential regulatory filings.
Bayer's Elinzanetant Shows Promise in Reducing Hot Flashes for Breast Cancer Patients
• Elinzanetant met primary endpoints in the Phase III OASIS 4 trial, significantly reducing the frequency of moderate to severe vasomotor symptoms (VMS) in women undergoing endocrine therapy for breast cancer.
• The study also achieved secondary endpoints, demonstrating a reduction in the severity of VMS, improvements in sleep disturbances, and enhanced menopause-related quality of life compared to placebo.
• Elinzanetant is a dual neurokinin-1 and 3 receptor antagonist, representing a potential non-hormonal treatment option for VMS in breast cancer patients and women at high risk.
• Bayer is advancing regulatory submissions for elinzanetant in the US, EU, and other global markets, with potential launch expected later this year, pending regulatory approvals.
AbbVie's Telisotuzumab Vedotin Shows Promise in c-Met Overexpressing NSCLC
• AbbVie's telisotuzumab vedotin (Teliso-V) demonstrated a 35% overall response rate in patients with high c-Met expression in the LUMINOSITY trial.
• The FDA granted breakthrough therapy designation to Teliso-V, highlighting its potential to significantly improve outcomes in NSCLC patients.
• A phase 3 trial (TeliMET-NSCLC-01) is underway, comparing Teliso-V to docetaxel in c-Met-positive, non-squamous NSCLC patients.
• Teliso-V targets c-Met, a protein involved in cancer progression and resistance to therapies like EGFR inhibitors, offering a novel approach.
Enhertu Approved for HER2-Low and HER2-Ultralow Metastatic Breast Cancer
• The FDA has approved Enhertu for HR-positive, HER2-low or HER2-ultralow metastatic breast cancer after endocrine therapy progression.
• DESTINY-Breast06 trial data showed a 36% reduction in disease progression or death risk compared to chemotherapy.
• Patients on Enhertu had a median progression-free survival of 13.2 months versus 8.1 months on chemotherapy.
• This approval expands Enhertu's use to an earlier treatment setting and a broader patient population.
Luspatercept Plus Lenalidomide Shows Promise in Non-del(5q) Myelodysplastic Syndrome
• A phase 1b trial combining luspatercept and lenalidomide demonstrates safety and preliminary efficacy in patients with non-del(5q) myelodysplastic syndrome (MDS).
• The combination therapy showed a 50% hematologic improvement rate among evaluable patients, with notable red blood cell transfusion independence.
• The study established a recommended phase 2 dose (RP2D) of lenalidomide at 10 mg daily and luspatercept at 1.0 mg/kg every 21 days.
• These findings support further investigation of this combination to improve outcomes for lower-risk MDS patients lacking the del(5q) abnormality.
FDA Reviews Accelerated Approvals for Keytruda, Opdivo, and Tecentriq in Multiple Cancers
• The FDA is re-evaluating the accelerated approvals of Merck's Keytruda, Bristol-Myers Squibb's Opdivo, and Roche's Tecentriq across six cancer types due to failed confirmatory trials.
• ODAC will discuss Tecentriq with Abraxane for advanced triple-negative breast cancer, focusing on alternative confirmatory studies after the Impassion131 trial failure.
• Keytruda and Tecentriq's first-line treatment status for urothelial carcinoma is under review, considering the approval of Bavencio as a first-line maintenance therapy.
• The committee will also assess Keytruda for gastric cancer and Keytruda/Opdivo for hepatocellular carcinoma, examining if the initial benefits have been confirmed.
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