On July 1, 2022 AstraZeneca reported that data for IMFINZI (durvalumab) combinations from the HIMALAYA and TOPAZ-1 Phase III trials at the European Association for the Study of the Liver’s International Liver Congress 2022 (EASL 2022) and the European Society for Medical Oncology’s World Congress on Gastrointestinal Cancer (ESMO World GI 2022) (Press release, AstraZeneca, JUL 1, 2022, View Source [SID1234616447]).
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Exploratory sub-analyses from HIMALAYA and TOPAZ-1 were presented at ESMO (Free ESMO Whitepaper) World GI 2022, June 29 to July 2 in Barcelona. Additionally, health-related quality-of-life data from HIMALAYA were presented at EASL 2022, June 22 to 26 in London.
Cristian Massacesi, Chief Medical Officer and Oncology Chief Development Officer, AstraZeneca, said: "The HIMALAYA results show a consistent survival benefit with the STRIDE regimen in patients with unresectable liver cancer regardless of baseline liver functional reserve, and TOPAZ-1 data show that IMFINZI plus chemotherapy improved outcomes for biliary tract cancer patients regardless of where their tumor was located or where they lived. These important subgroup analyses add to the body of evidence demonstrating the potential for IMFINZI combinations to meaningfully improve outcomes for these patients who are in need of effective and generally well tolerated treatments."
HIMALAYA Phase III analyses in unresectable liver cancer at ESMO (Free ESMO Whitepaper) World GI 2022 and EASL 2022
An exploratory sub-analysis from the HIMALAYA Phase III trial evaluated the efficacy and safety of the STRIDE regimen (single tremelimumab regular interval durvalumab) or durvalumab monotherapy versus sorafenib by baseline liver function, and liver function over time in patients with unresectable liver cancer. Liver function was determined using the ALBI (albumin-bilirubin) scoring system, a model for assessing the severity of liver dysfunction that describes worsening severity across three grades (ALBI grades 1 through 3).
Patients with liver cancer tend to have underlying liver cirrhosis, leading to impaired liver function and poor prognosis.1 Systemic therapies for advanced liver cancer have the potential to exacerbate pre-existing liver disease and increase the risk of liver-related adverse events. Data presented at ESMO (Free ESMO Whitepaper) World GI 2022 showed that the STRIDE regimen improved survival regardless of liver function scores at baseline, with overall survival (OS) hazard ratios (HR) that were generally consistent with the primary analysis in both the ALBI grade 1 subgroup (HR 0.79; 95% confidence interval [CI] 0.62-1.01) and ALBI grade 2/3 subgroup (HR 0.83; 95% CI 0.65-1.05).2 The overall response rate, duration of response and tolerability profile for STRIDE were consistent regardless of ALBI score.2 Further, liver function was stable over time for patients treated with STRIDE who remained on the trial.
An additional analysis from the HIMALAYA trial was conducted using a self-reported questionnaire to assess the impact of treatment and treatment status on health-related quality-of-life in patients with unresectable liver cancer. Results presented at EASL 2022 demonstrated that patients treated with the STRIDE regimen had better quality-of-life than those treated with sorafenib, with fewer patients experiencing moderate to severe problems in domains including mobility, self-care, pain/discomfort and anxiety/depression.3 Further, treatment discontinuation was associated with a larger magnitude of worsening health status than disease progression. Following discontinuation, more patients reported experiencing moderate to extreme problems on all domains.3 These results highlight the impact of treatment discontinuation and the potential quality-of-life benefits for maintaining patients on treatment with the STRIDE regimen.
Primary results from the HIMALAYA Phase III trial were presented during the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers (ASCO GI) Symposium in January 2022 and published in New England Journal of Medicine (NEJM) Evidence in June 2022. The trial met its primary endpoint demonstrating a statistically significant improvement of OS with a single priming dose of tremelimumab plus durvalumab every four weeks versus sorafenib.4 The safety profiles of the STRIDE regimen and for durvalumab alone were consistent with the known profiles of each medicine, and no new safety signals were identified.4
TOPAZ-1 Phase III trial subgroup analysis in advanced biliary tract cancer at ESMO (Free ESMO Whitepaper) World GI 2022
An exploratory subgroup analysis of patients enrolled in the TOPAZ-1 Phase III trial evaluated the efficacy and safety of durvalumab plus standard-of-care chemotherapy (gemcitabine plus cisplatin) compared to placebo plus chemotherapy by primary tumor location, including intrahepatic and extrahepatic cholangiocarcinoma and gallbladder cancer.
The analysis showed a consistent OS benefit for patients treated with durvalumab and chemotherapy (gemcitabine plus cisplatin) compared to chemotherapy alone across all primary tumor locations, with an improved OS with durvalumab: intrahepatic cholangiocarcinoma (HR 0.76; 95% CI 0.58-0.98), extrahepatic cholangiocarcinoma (HR 0.76; 95% CI 0.49-1.19) and gallbladder cancer (HR 0.94; 95% CI 0.65-1.37).5 This consistent OS benefit was observed regardless of geographic location, with patients in North America, Europe and Asia all showing benefit. The incidence of grade 3 or 4 adverse events and treatment-related adverse events were generally comparable among treatment groups, irrespective of primary tumor locations.
Primary results from the TOPAZ-1 trial were presented during the ASCO (Free ASCO Whitepaper) GI Symposium in January 2022 and published in NEJM Evidence in June 2022. Durvalumab in combination with standard-of-care chemotherapy demonstrated a statistically significant and clinically meaningful OS benefit versus chemotherapy alone, meeting the primary endpoint.6 Durvalumab plus chemotherapy did not increase the discontinuation rate due to adverse events compared to chemotherapy alone.6
IMPORTANT SAFETY INFORMATION
There are no contraindications for IMFINZI (durvalumab).
Immune-Mediated Adverse Reactions
Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue IMFINZI depending on severity. See Dosing and Administration for specific details. In general, if IMFINZI requires interruption or discontinuation, administer systemic corticosteroid therapy (1 mg to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.
Immune-Mediated Pneumonitis
IMFINZI can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients who did not receive recent prior radiation, the incidence of immune-mediated pneumonitis was 2.4% (34/1414), including fatal (<0.1%), and Grade 3-4 (0.4%) adverse reactions. In patients who received recent prior radiation, the incidence of pneumonitis (including radiation pneumonitis) in patients with unresectable Stage III NSCLC following definitive chemoradiation within 42 days prior to initiation of IMFINZI in PACIFIC was 18.3% (87/475) in patients receiving IMFINZI and 12.8% (30/234) in patients receiving placebo. Of the patients who received IMFINZI (475), 1.1% were fatal and 2.7% were Grade 3 adverse reactions. The frequency and severity of immune-mediated pneumonitis in patients who did not receive definitive chemoradiation prior to IMFINZI were similar in patients who received IMFINZI as a single agent or with ES-SCLC when in combination with chemotherapy.
Immune-Mediated Colitis
IMFINZI can cause immune-mediated colitis that is frequently associated with diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Immune-mediated colitis occurred in 2% (37/1889) of patients receiving IMFINZI, including Grade 4 (<0.1%) and Grade 3 (0.4%) adverse reactions.
Immune-Mediated Hepatitis
IMFINZI can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 2.8% (52/1889) of patients receiving IMFINZI, including fatal (0.2%), Grade 4 (0.3%) and Grade 3 (1.4%) adverse reactions.
Immune-Mediated Endocrinopathies
Adrenal Insufficiency: IMFINZI can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Immune-mediated adrenal insufficiency occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
Hypophysitis: IMFINZI can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. Hypophysitis can cause hypopituitarism. Initiate symptomatic treatment including hormone replacement as clinically indicated. Grade 3 hypophysitis/hypopituitarism occurred in <0.1% (1/1889) of patients who received IMFINZI.
Thyroid Disorders: IMFINZI can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement therapy for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated.
Thyroiditis: Immune-mediated thyroiditis occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
Hyperthyroidism: Immune-mediated hyperthyroidism occurred in 2.1% (39/1889) of patients receiving IMFINZI.
Hypothyroidism: Immune-mediated hypothyroidism occurred in 8.3% (156/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
Type 1 Diabetes Mellitus, which can present with diabetic ketoacidosis: Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. Grade 3 immune-mediated type 1 diabetes mellitus occurred in <0.1% (1/1889) of patients receiving IMFINZI.
Immune-Mediated Nephritis with Renal Dysfunction
IMFINZI can cause immune-mediated nephritis. Immune-mediated nephritis occurred in 0.5% (10/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions.
Immune-Mediated Dermatology Reactions
IMFINZI can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson Syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN), have occurred with PD-1/L-1 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes. Immune-mediated rash or dermatitis occurred in 1.8% (34/1889) of patients receiving IMFINZI, including Grade 3 (0.4%) adverse reactions.
Other Immune-Mediated Adverse Reactions
The following clinically significant, immune-mediated adverse reactions occurred at an incidence of less than 1% each in patients who received IMFINZI or were reported with the use of other PD-1/PD-L1 blocking antibodies.
Cardiac/vascular: Myocarditis, pericarditis, vasculitis.
Nervous system: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy.
Ocular: Uveitis, iritis, and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment to include blindness can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss.
Gastrointestinal: Pancreatitis including increases in serum amylase and lipase levels, gastritis, duodenitis.
Musculoskeletal and connective tissue disorders: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatic.
Endocrine: Hypoparathyroidism
Other (hematologic/immune): Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenia, solid organ transplant rejection.
Infusion-Related Reactions
IMFINZI can cause severe or life-threatening infusion-related reactions. Monitor for signs and symptoms of infusion-related reactions. Interrupt, slow the rate of, or permanently discontinue IMFINZI based on the severity. See Dosing and Administration for specific details. For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses. Infusion-related reactions occurred in 2.2% (42/1889) of patients receiving IMFINZI, including Grade 3 (0.3%) adverse reactions.
Complications of Allogeneic HSCT after IMFINZI
Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/L-1 blocking antibody. Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1/L-1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1/L-1 blocking antibody prior to or after an allogeneic HSCT.
Embryo-Fetal Toxicity
Based on its mechanism of action and data from animal studies, IMFINZI can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with IMFINZI and for at least 3 months after the last dose of IMFINZI.
Lactation
There is no information regarding the presence of IMFINZI in human milk; however, because of the potential for adverse reactions in breastfed infants from IMFINZI, advise women not to breastfeed during treatment and for at least 3 months after the last dose.
Adverse Reactions
In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), the most common adverse reactions (≥20%) were cough (40%), fatigue (34%), pneumonitis or radiation pneumonitis (34%), upper respiratory tract infections (26%), dyspnea (25%), and rash (23%). The most common Grade 3 or 4 adverse reactions (≥3%) were pneumonitis/radiation pneumonitis (3.4%) and pneumonia (7%)
In patients with Stage III NSCLC in the PACIFIC study receiving IMFINZI (n=475), discontinuation due to adverse reactions occurred in 15% of patients in the IMFINZI arm. Serious adverse reactions occurred in 29% of patients receiving IMFINZI. The most frequent serious adverse reactions (≥2%) were pneumonitis or radiation pneumonitis (7%) and pneumonia (6%). Fatal pneumonitis or radiation pneumonitis and fatal pneumonia occurred in <2% of patients and were similar across arms
In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), the most common adverse reactions (≥20%) were nausea (34%), fatigue/asthenia (32%), and alopecia (31%). The most common Grade 3 or 4 adverse reaction (≥3%) was fatigue/asthenia (3.4%)
In patients with extensive-stage SCLC in the CASPIAN study receiving IMFINZI plus chemotherapy (n=265), IMFINZI was discontinued due to adverse reactions in 7% of the patients receiving IMFINZI plus chemotherapy. Serious adverse reactions occurred in 31% of patients receiving IMFINZI plus chemotherapy. The most frequent serious adverse reactions reported in at least 1% of patients were febrile neutropenia (4.5%), pneumonia (2.3%), anemia (1.9%), pancytopenia (1.5%), pneumonitis (1.1%), and COPD (1.1%). Fatal adverse reactions occurred in 4.9% of patients receiving IMFINZI plus chemotherapy
The safety and effectiveness of IMFINZI have not been established in pediatric patients.
Indications:
IMFINZI is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC).
Please see complete Prescribing Information, including Medication Guide.
Notes
Liver cancer
Liver cancer is the third-leading cause of cancer death and sixth most commonly diagnosed cancer worldwide.7 About 75% of all primary liver cancers in adults are HCC.8 Between 80-90% of all patients with HCC also have cirrhosis.1 Chronic liver diseases are associated with inflammation that over time can lead to the development of HCC.1
More than half of patients are diagnosed at advanced stages of the disease, often when symptoms first appear.9 A critical unmet need exists for patients with HCC who face limited treatment options.9 The unique immune environment of liver cancer provides clear rationale for investigating medications that harness the immune system to treat HCC.9
Biliary tract cancer
Biliary tract cancer (BTC) is a group of rare and aggressive gastrointestinal (GI) cancers that form in the cells of the bile ducts (cholangiocarcinoma), gallbladder or ampulla of Vater (where the bile duct and pancreatic duct connect to the small intestine).10,11
Cholangiocarcinoma is more common in China and South-East Asia and is on the rise in Western countries.10,12 Gallbladder cancer is more common in certain regions of South America, India and Japan.13 Approximately 50,000 people in the US, Europe and Japan and about 210,000 people worldwide are diagnosed with BTC each year.14-16
Early-stage BTC affecting the bile ducts and gallbladder often presents without clear symptoms and most new cases of BTC are therefore diagnosed at an advanced stage, when treatment options are limited and the prognosis is poor.12,13,17 Approximately 5% to 15% of patients with BTC survive five years. 12
HIMALAYA
HIMALAYA was a randomized, open-label, multicenter, global Phase III trial of IMFINZI monotherapy and the STRIDE regimen, comprising a single priming dose of tremelimumab 300mg added to IMFINZI 1500mg followed by IMFINZI every four weeks versus sorafenib, a standard-of-care multi-kinase inhibitor.
The trial included a total of 1,324 patients with unresectable, advanced HCC who had not been treated with prior systemic therapy and were not eligible for locoregional therapy (treatment localized to the liver and surrounding tissue).
The trial was conducted in 181 centers across 16 countries, including in the US, Canada, Europe, South America and Asia. The primary endpoint is OS for STRIDE versus sorafenib and key secondary endpoints included OS for IMFINZI versus sorafenib, objective response rate and progression-free survival (PFS) for STRIDE and for IMFINZI alone.
TOPAZ-1
TOPAZ-1 is a randomized, double-blind, placebo controlled, multicenter, global Phase III trial of IMFINZI in combination with chemotherapy (gemcitabine plus cisplatin) versus placebo in combination with chemotherapy as a 1st-line treatment in 685 patients with unresectable advanced or metastatic BTC including intrahepatic and extrahepatic cholangiocarcinoma, and gallbladder cancer. Patients with ampullary carcinoma were excluded.
The primary endpoint is OS and key secondary endpoints included PFS, objective response rate and safety. The trial was conducted in 105 centers across 17 countries including in the US, Europe, South America and several countries in Asia including South Korea, Thailand, Japan and China.
IMFINZI
IMFINZI (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, countering the tumor’s immune-evading tactics and releasing the inhibition of immune responses.
IMFINZI is the only approved immunotherapy in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiotherapy, and is the global standard of care in this setting based on the PACIFIC Phase III trial.
IMFINZI is also approved in the US, EU, Japan, China and many other countries around the world for the treatment of extensive-stage small cell lung cancer (ES-SCLC) based on the CASPIAN Phase III trial. In 2021, updated results from the CASPIAN trial showed IMFINZI plus chemotherapy tripled patient survival at three years versus chemotherapy alone.
IMFINZI is also approved for previously treated patients with advanced bladder cancer in several countries.
Since the first approval in May 2017, more than 100,000 patients have been treated with IMFINZI.
As part of a broad development program, IMFINZI is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with small cell lung cancer (SCLC), NSCLC, bladder cancer, several GI cancers, ovarian cancer, endometrial cancer, and other solid tumors.
In the past year, IMFINZI has demonstrated clinical benefit in multiple additional cancer settings with positive Phase III trials in advanced BTC (TOPAZ-1), unresectable advanced liver cancer (HIMALAYA) and metastatic NSCLC (POSEIDON).
Tremelimumab
is a human monoclonal antibody and potential new medicine that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Tremelimumab blocks the activity of CTLA-4, contributing to T-cell activation, priming the immune response to cancer and fostering cancer cell death.
Beyond HIMALAYA, tremelimumab is being tested in combination with IMFINZI across multiple tumor types including locoregional HCC (EMERALD-3), SCLC (ADRIATIC) and bladder cancer (VOLGA and NILE).
Tremelimumab is also under review by global regulatory authorities in combination with IMFINZI and chemotherapy in 1st-line metastatic NSCLC based on the results of the POSEIDON Phase III trial, which showed the addition of a short course of tremelimumab to IMFINZI plus chemotherapy improved both OS and PFS compared to chemotherapy alone.
AstraZeneca in GI cancers
AstraZeneca has a broad development program for the treatment of GI cancers across several medicines and a variety of tumor types and stages of disease. In 2020, GI cancers collectively represented approximately 5.1 million new cancer cases leading to approximately 3.6 million deaths worldwide.18
Within this program, the Company is committed to improving outcomes in gastric, liver, BTC, esophageal, pancreatic, and colorectal cancers.
IMFINZI is being assessed in combinations in liver, BTC, esophageal and gastric cancers in an extensive development program spanning early to late-stage disease.
The Company aims to understand the potential of fam-trastuzumab deruxtecan-nxki, a HER2-directed antibody drug conjugate, in the two most common GI cancers, colorectal and gastric cancers. Fam-trastuzumab deruxtecan-nxki is jointly developed and commercialized by AstraZeneca and Daiichi Sankyo.
Olaparib is a first-in-class PARP inhibitor with a broad and advanced clinical trial program across multiple GI tumor types including pancreatic and colorectal cancers. Olaparib is developed and commercialized in collaboration with Merck & Co., Inc., Kenilworth, NJ, US, known as MSD outside the US and Canada.
AstraZeneca in immunotherapy
Immunotherapy is a therapeutic approach designed to stimulate the body’s immune system to attack tumors. The Company’s Immuno-Oncology (IO) portfolio is anchored in immunotherapies that have been designed to overcome evasion of the anti-tumor immune response. AstraZeneca is invested in using IO approaches that deliver long-term survival for new groups of patients across tumor types.
The Company is pursuing a comprehensive clinical-trial program that includes IMFINZI as a single treatment and in combination with tremelimumab and other novel antibodies in multiple tumor types, stages of disease, and lines of treatment, and where relevant using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient.
In addition, the ability to combine the IO portfolio with radiation, chemotherapy, and targeted small molecules from across AstraZeneca’s oncology pipeline, and from research partners, may provide new treatment options across a broad range of tumors.
AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, 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 cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyze changes in the practice of medicine and transform the patient experience.
AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.