1. AbbVie Updates Phase 2 EPCORE® NHL-6 Trial Results for Epcoritamab in Relapsed/Refractory DLBCL
On Sep 3 2025, Abbvie represented updated results from the Phase 2 EPCORE® NHL-6 trial. This open-label study assessed the feasibility of administering the bispecific antibody epcoritamab as a subcutaneous monotherapy in an outpatient setting for adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who had previously received at least one line of systemic therapy. In the study, 88 patients received the first full dose (48 mg) of epcoritamab monotherapy.
With a median follow-up of 5.8 months, the study reported an overall response rate (ORR) of 64.3% and a complete response (CR) rate of 47.6% in patients who had received only one prior line of therapy. In patients with two or more prior lines of therapy (median follow-up: 10.8 months), the ORR was 60.0%, and the CR rate was 38.0%.
These findings suggest that epcoritamab can be safely administered in an outpatient setting, potentially improving patient access to treatment and reducing the need for hospital-based monitoring.
2. Sanofi Announces Positive Phase 3 Results for Amlitelimab in Moderate-to-Severe Atopic Dermatitis
On Sep 4 2025, Sanofi announced positive results from the COAST 1 phase 3 study evaluating amlitelimab, a monoclonal antibody targeting OX40-ligand (OX40L) in patients with moderate-to-severe atopic dermatitis. The study demonstrated that amlitelimab, administered either every four weeks (Q4W) or every 12 weeks (Q12W), achieved statistically significant and clinically meaningful improvements in skin clearance and disease severity compared to placebo at Week 24.
The results showed that for vIGA-AD 0/1, at Week 24, 21.1% of patients in the Q4W group and 22.5% in the Q12W group achieved this, compared to 9.2% in the placebo group (both with p-values <0.01). For EASI-75, 35.9% of patients in the Q4W group and 39.1% in the Q12W group achieved the endpoint, compared to 19.1% in the placebo group.
Link: https://www.sanofi.com/en/media-room/press-releases/2025/2025-09-04-05-00-00-3144170
3. Tagrisso Combination Therapy Improves Survival in EGFR-Mutated NSCLC
On Sep 7 2025, AstraZeneca announced that the combination therapy of Tagrisso (osimertinib) with the addition of chemotherapy has achieved a median overall survival of 47.5 months in patients with EGFR-mutated advanced non-small cell lung cancer (NSCLC). It showed that the combination therapy reduced the risk of death by 23% compared to Tagrisso monotherapy. An estimated 63.1% of patients treated with the combination were alive at three years, and 49.1% were alive at four years, compared to 50.9% and 40.8%, respectively, in the monotherapy arm.
4. VONVENDI® Receives Expanded FDA Approval for Routine Prophylaxis in Von Willebrand Disease
On Sep 5 2025, Takeda announced that the U.S. FDA had approved an expanded indication for VONVENDI® (von Willebrand factor [Recombinant]) to treat von Willebrand disease (vWD). VWD is the most common hereditary blood-clotting disorder caused by a deficiency or dysfunction of von Willebrand factor (vWF). VONVENDI is designed to replace the body's missing or dysfunctional vWF.
The approval extends VONVENDI's use to include routine prophylaxis to reduce the frequency of bleeding episodes in adults with Type 1 and Type 2 vWD, as well as on-demand and perioperative management. This expanded approval is based on data from three clinical trials: a Phase 3 trial in adults with vWD, a Phase 3 study in children with vWD, and a Phase 3b continuation trial in both adults and children.
Link: https://www.takeda.com/newsroom/newsreleases/2025/expanded-indication-vonvendi/
5. Trastuzumab Pamirtecan showed Positive Results in HER2-Positive Metastatic Breast Cancer
On Sep 5 2025, BioNTech and Duality Biologics announced that the pivotal Phase 3 trial (NCT06265428) of trastuzumab pamirtecan (BNT323/DB-1303), a next-generation antibody-drug conjugate (ADC) in HER2-positive metastatic breast cancer patients. The trial had met its primary endpoint with positive progression-free survival outcomes. This trial compared trastuzumab pamirtecan to trastuzumab emtansine (T-DM1) in patients who had previously received trastuzumab and a taxane-based chemotherapy.
6. Encaleret showed Positive in Post-Surgical Hypoparathyroidism Management
On Sep 6 2025, BridgeBio Pharma announced results for encaleret an oral calcilytic therapy, in the treatment of post-surgical hypoparathyroidism. In a proof-of-concept study involving 10 participants, 80% achieved normal blood and 24-hour urine calcium levels within 5 days of initiating Encaleret treatment, compared to 0% with conventional therapy at baseline. The treatment demonstrated parathyroid hormone (PTH)-independent normalisation of calcium levels, addressing a significant challenge in managing this condition.
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