Prednisone

IMFINZI plus IMJUDO combined with lenvatinib and TACE demonstrated a statistically significant and clinically meaningful improvement in progression-free survival in embolization-eligible unresectable liver cancer in EMERALD-3 Phase III trial IMFINZI plus IMJUDO combined with lenvatinib and transarterial chemoembolization (TACE) showed trend toward improved overall survival WILMINGTON, Del.--(BUSINESS WIRE)--Positive high-level results from the EMERALD-3 Phase III trial showed AstraZeneca’s IMFINZI ® (durvalumab) in combination with IMJUDO ® (tremelimumab-actl), lenvatinib and transarterial chemoembolization (TACE) demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) versus TACE alone for patients with unresectable hepatocellular carcinoma (HCC) eligible for embolization. At this interim analysis for overall survival (OS), a key secondary endpoint, this combination also demonstrated a trend toward OS improvement versus TACE alone. Patients in the investigational arms were treated with the STRIDE regimen (Single Tremelimumab-actl Regular Interval Durvalumab), with or without lenvatinib, before TACE, and then alongside TACE. Although not formally tested at this time, data for the treatment arm evaluating the STRIDE regimen plus TACE versus TACE alone showed strong trends toward improved PFS and OS. The trial will continue to follow OS and other key secondary endpoints in both investigational arms. HCC is the most common type of liver cancer. 1 In 2026, more than 200,000 patients with HCC will be eligible for embolization, a standard-of-care procedure that blocks the blood supply to the tumor and can also deliver chemotherapy directly to the liver. 2-4 However, most patients who receive embolization experience disease progression or recurrence within six to 10 months. 5 Ghassan Abou-Alfa, MD, JD, MBA, PhD(hc), Attending Physician, Professor of Medicine at Memorial Sloan Kettering Cancer Center, and principal investigator in the trial, said: “Dual immunotherapy with durvalumab and tremelimumab-actl in the STRIDE regimen represents a meaningful advance for patients with embolization-eligible liver cancer, who currently lack systemic treatment options to keep their cancer from progressing or recurring, with a trend of improving survival. EMERALD‑3 shows we can now significantly reduce the risk of disease progression with STRIDE as the immunotherapy backbone alongside lenvatinib and TACE.” Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “EMERALD‑3 now shows that bringing the dual immunotherapy STRIDE regimen earlier, alongside TACE and lenvatinib, can further improve outcomes in earlier‑stage liver cancer. This builds on the HIMALAYA Phase III trial data in patients with advanced, unresectable disease, where the STRIDE regimen has already demonstrated durable overall survival benefit. We are discussing these positive data with global regulatory authorities while awaiting the final results from the key secondary endpoints.” The safety pro each combination was consistent with the known profiles of each medicine, and there were no new safety findings. These data will be presented at a forthcoming medical meeting and shared with global regulatory authorities. IMPORTANT SAFETY INFORMATION There are no contraindications for IMFINZI ® (durvalumab) or IMJUDO ® (tremelimumab-actl). Severe and Fatal 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 clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and before each dose. 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 and IMJUDO depending on severity. See USPI Dosing and Administration for specific details. In general, if IMFINZI and IMJUDO 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 and IMJUDO can cause immune-mediated pneumonitis, which may be fatal. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. IMFINZI as a Single Agent In patients who did not receive recent prior radiation, the incidence of immune-mediated pneumonitis was 2.4% (34/1414), including fatal (1% of patients were pneumonia (1.9%), pneumonitis (1.1%), and COVID-19 (1.1%). Four fatal adverse reactions occurred during the adjuvant phase of the study, including COVID-19 pneumonia, pneumonia aspiration, interstitial lung disease and aortic aneurysm. Metastatic NSCLC In patients with mNSCLC in the POSEIDON study receiving IMFINZI and IMJUDO plus platinum-based chemotherapy (n=330), the most common adverse reactions (occurring in ≥20% of patients) were nausea (42%), fatigue (36%), musculoskeletal pain (29%), decreased appetite (28%), rash (27%), and diarrhea (22%). In patients with mNSCLC in the POSEIDON study receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy (n=330), permanent discontinuation of IMFINZI or IMJUDO due to an adverse reaction occurred in 17% of patients. Serious adverse reactions occurred in 44% of patients, with the most frequent serious adverse reactions reported in at least 2% of patients being pneumonia (11%), anemia (5%), diarrhea (2.4%), thrombocytopenia (2.4%), pyrexia (2.4%), and febrile neutropenia (2.1%). Fatal adverse reactions occurred in a total of 4.2% of patients. Limited-stage Small Cell Lung Cancer In patients with limited-stage SCLC in the ADRIATIC study receiving IMFINZI (n=262), the most common adverse reactions occurring in ≥20% of patients receiving IMFINZI were pneumonitis or radiation pneumonitis (38%), and fatigue (21%). Contacts Media Inquiries Lauren-Jei McCarthy +1 347 918 7001 US Media Mailbox: usmediateam@astrazeneca.com Read full story here

WEDNESDAY, April 1, 2026 -- For adults with dermatomyositis , brepocitinib, an oral tyrosine kinase 2/Janus kinase 1 inhibitor, demonstrates significant benefits at a 30-mg dose compared with placebo, according to a study published online March 28 in the New England Journal of Medicine to coincide with the annual meeting of the American Academy of Dermatology, held from March 27 to 31 in Denver. Ruth Ann Vleugels, M.D., M.P.H., from Harvard Medical School in Boston, and colleagues conducted a phase 3, double-blind, randomized trial involving adults with dermatomyositis. Participants were randomly assigned to oral brepocitinib 30 mg, brepocitinib 15 mg, or placebo once daily for 52 weeks (81, 81, and 79 participants, respectively). The researchers found that the mean Total Improvement Scores (TIS) at week 52 were 46.5, 37.5, and 31.2, respectively (brepocitinib 30 mg versus placebo difference: 15.3). On all nine key secondary end points, brepocitinib 30 mg was superior to placebo, including Cutaneous Dermatomyositis Disease Severity Index-Activity at week 4, moderate TIS response at week 52 with ≤2.5 mg/day of prednisone equivalent, and Health Assessment Questionnaire-Disability Index at week 52. The brepocitinib 30-mg arm had an increase in serious infections (9.9 percent versus 1.3 percent in placebo), but malignancies, thromboembolic events, and cardiovascular events were more frequent with placebo. There were no deaths reported. "These findings underscore the need to move beyond the historical paradigm of suboptimal disease control and reliance on systemic corticosteroids toward a patient-centric model focused on rapid, sustained, steroid-sparing efficacy with a modern, targeted therapy," Vleugels said in a statement. Several authors disclosed ties to Priovant Therapeutics, which is developing brepocitinib and funded the study. Abstract/Full Text (subscription or payment may be required) More Information