The BlenreP (Belantamab Mafodotin) combination was approved by MHRA in the relapse and refractory bone marrow.

The excellent efficacy shown in two head-to-head III steps, including the overall survival of the Dreamm-7 Blenep combination, can be redefined early with the first recurrence that requires more effective options.

GSK PLC (LSE/NYSE: GSK) announced today's approval of BlenreP of the Medicine and Medical Products Regulatory Organization (MHRA). In the UK, Blenep combines with at least one dictionary therapy in combination with Bortte Jominib + Dexemetasone (BVD) to treat adults with multiple bone marrow species and pomalidomide + dexamethasone (BPD) in patients with at least one treatment, including renalimide. Combined and approved. The UK's regulatory approval is first shown in this therapeutic environment in Blenep's world.

Excellent efficacy comes from the pivotal Dreamm-7 and Dreamm-8 in the recurrent or refractory multi-bone marrow species. This includes statistically significant and clinically meaningful and clinically meaningful non -survival (PFS) results for the Blenep combination. The standard of the Blenep combination and the entire survival standard and the full survival standard (OS) of the Dreamm-7.2,3,4 have a wide range of the safety and tolerable profiles of the Blenep combination with the known profiles of individual agents.

Hesham Abdullah, chief executive vice president of GSK's R & D International International State Department, said: Today's approval for the Blenep combination in the UK is a cancer marked by the modified mint, mitigation and recurrence of multiple bone marrow patients. As the only BCMA-targeted ADC therapy, BlenreP has the potential supported by strong III step data, and can extend treatment and treatment standard treatment at the first recurrence.

At present, most patients with multiple bone marrow have experienced recurrence, and in the UK, only 55% survived five years after diagnosis. The Blenep combination can be administered in various types of patient in all oncology treatments without complex pre -administration or hospitalization.

Joseph Mikhael, a professor of conversion genome research institute at the International Myeloma Foundation of the City of Hope Cancer Center I said: We are pleased to see patients with many developments in the therapeutic environment and to expand in the academic and community environment.

The Dreamm-7 and Dreamm-8 showed statistically significant and clinically significant PFS improvements to Blenref combination compared to the second line or subsequent treatment triple combination of multiple myeloma. [HR]: 0.41 [95% confidence interval (CI): 0.31-0.53]P-value <0.00001) .2 Dreamm-7 meets the main secondary endpoint of the OS and shows a 42% decrease in the central value of the intermediate combination (n = 243) of the Blenep combination (n = 243) compared to the Daratumamab-based comparison (n = 251). (HR 0.58; 95%CI: 0.43-0.79; p = 0.00023). In Dreamm-8, in the 21.8-month average tracking observation, the intermediate PFS has not yet reached in the Blenep combination compared to 12.7 months in the BORTEZOMIB combination.

The BlenreP combination consistently benefited from a wide range of prognosis characteristics such as high -risk cell genetics or fire resistance to lenalidomide, or a wide range of patients, including patients with poor results. The two exams also showed clinically significant improvements across all other secondary efficacy, including each comparator and deeper and more durable reactions.

BlenreP's known side effects, which are known side effects of treatment, were generally solved and can be managed for a long time between injection and dose reduction while maintaining efficacy, and the most commonly reported side effects (30%) in both exams were Slenep combination (87%). In Dreamm-7 (32%) and neutrophil decrease (63%), platelet reduction (55%) and COVID-19 (37%) Dreamm-8 (37%).

The Blenep Combinations is currently included with the United States on July 23, 2025, with the European Union (PDUFA) date, 7 JAPAN (Priority Review), 8 China (DREAM-7) (Combination and Priority Review Results), 9 Canada and Switzerland (Dreamm-8) It is being reviewed in 14 countries, including the United States.

About multiple myeloma

Multiple myeloma is the third most common blood cancer worldwide and is generally considered to be treated, but it is considered to be untreated. There are more than 180,000 multiple myeloma that are diagnosed worldwide every year. There are new cases of multiple myeloma with more than 6,500 new plants and more than 19,400 prevalence in the UK. 13,14 Searches for multiple bone marrow species are generally unfavorable for treatment. It must be. Center.15,16

About Blenep

Blenrep is an ADC comprising a humanized BCMA monoclonal antibody bonded with a cell toxic agent Auristatin F through an unknown linker. The drug linker technology was licensed from Seagen Inc. Single clone antibodies are produced using PATELLIGENT technology licensed by Biowa Inc., a member of Kyowa Kirin Group.

mark

In the UK, BlenreP is displayed to adults for the treatment of multiple myeloma.

In patients with at least one dictionary therapy with Bortte Chiminib and Dexamethasone; And with Poma Ridomide and Dexamethasone in patients with at least one dictionary therapy, including renalidomide. Blenep's important safety information

For more information, you can check the product characteristics and the Blenep summary of the product characteristics and patient information leaflets that will be posted on the MHRA Products website within 7 days of approval.

Dreamm-7

Dreamm-7 is a Belantamab Mafodotin combined with the bold deckmumab combined with the bold deckmumab combined with the minimal Exameb + dexamethasone (DVD) and the bold deckmumab combined with the bortezomib + dexamethason (DVD). It is a plurality of open labels, random III phase clinical trials that assess the efficacy and safety of Belantamab Mafodotin combined with (BVD). During the latest therapy, with the progression of documented diseases, multiple myeloma therapy. This test registered 494 participants who randomly assigned a random 1: 1 to receive BVD or DVD. Belantamab Mafodotin was administered at a capacity of 2.5 mg/kg every three weeks. The first terminal was PFS according to the Independent Review Committee, including the OS, the Reaction Period (DOR), and the minimum residual disease (MRD) negative speed. Other secondary endpoints include the overall response speed (ORR), safety and patient reporting and quality of life. The results were first announced in February 2024 at the ASCO (American Society of Clinical Oncology) General Assembly and announced in the New England Journal of Medicine.

About Dreamm-8

Dreamm-8 is a multi-center, open label, and random III phase clinical trial that assesses the efficacy and safety of Belantamab Mapodotin (BPD) in combination with Bellangamabpodotin (BPD) in combination with patients who have treated multiple Myroma according to the liturgy. The person who recorded the progression of the bone marrow therapy and the most recent treatment, including lenalido-mid-containing therapy. The test includes 302 participants who randomly random 1: 1 to receive BPD or PVD. Compared to the patient group studied in the Dreamm-7 exam, the patients of the Dreamm-8 were all prior exposure to lenalidomide, 78%were rejected for Renalido Mid, 25%were exposed to Daratumumab, and the largest of the largest people were the largest Tomuverion. Belantamab Mafodotin was administered to the first cycle of 2.5 mg/kg in the vein and at 1.9 mg/kg in the vein every four weeks. The first terminal was PFS according to the Independent Review Committee, and the main secondary ends including OS and MRD negative rate evaluated by next -generation sequencing. Other secondary endpoints include ORR, DOR, safety and patient reporting and quality of life. The results were first announced at the 2024 ASCO annual meeting and were presented in New England Journal of Medicine.

GSK of Oncology

Oncology is a new therapeutic area for GSK to maximize patient survival by focusing on hematological malignant tumors, female scientific cancer and other solid tumors through innovation of immune oncology and tumor-cell target therapy.

About GSK

GSK is a global bio pharmaceutical company that integrates science, technology and talents to lead the disease together. Check out the details on gsk.com.

Statement to the future prediction statement

GSK warns that the future prediction statements or predictions written by GSK, including the contents written by investors in this presentation, require the actual results to receive different risks and uncertainty. These factors include, but are not limited to the factors described in the risk factor section of the GSKS annual report on the 2024 form 20-f.

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