1.Roche’s giredestrant becomes the first oral SERD to show superior invasive disease-free survival in early breast cancer
On November 18, 2025, Roche announced positive results from the Phase III lidERA study of its investigational oral selective estrogen receptor degrader (SERD) giredestrant. The study, targeting patients with ER-positive, HER2-negative early breast cancer, met its primary endpoint at a pre-planned interim analysis, demonstrating a statistically significant improvement in invasive disease-free survival compared to standard-of-care endocrine monotherapy, making giredestrant the first oral SERD to show such benefit in the adjuvant treatment setting. The drug was well-tolerated with a safety profile consistent with its known characteristics, and while overall survival data were immature, a clear positive trend was observed. Relevant data will be presented at an upcoming medical meeting and submitted to health authorities worldwide, with the potential to become a new standard endocrine therapy for this type of breast cancer. This marks the second positive Phase III trial for giredestrant following the evERA study presented at the 2025 ESMO Congress, and together with previous evidence from neoadjuvant treatment-related studies, supports its potential to improve patient outcomes in both ER-positive early and advanced breast cancer. Since ER-positive breast cancer accounts for approximately 70% of all breast cancer cases, and currently some patients experience recurrence after treatment or discontinue therapy due to tolerability issues, the progress of this drug is expected to address unmet clinical needs.
Link：https://www.roche.com/media/releases/med-cor-2025-11-18
2.U.S. FDA Approves EPKINLY® (epcoritamab-bysp) in Combination with Rituximab and Lenalidomide for Relapsed or Refractory Follicular Lymphoma
On November 18, 2025, AbbVie announced that the U.S. Food and Drug Administration (FDA) has approved EPKINLY® (epcoritamab-bysp), a subcutaneously administered T-cell engaging bispecific antibody, in combination with rituximab and lenalidomide (the EPKINLY + R2 regimen) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least one line of systemic therapy. This marks the first and only approved bispecific antibody combination therapy for this indication, as well as EPKINLY’s third indication and the first FDA approval of a bispecific combination therapy in lymphoma.
The approval is based on results from the pivotal Phase 3 EPCORE FL-1 study, which compared fixed-duration EPKINLY + R2 with standard-of-care R2. The study demonstrated that the EPKINLY + R2 group achieved a 79% reduction in the risk of disease progression or death (HR=0.21, p<0.0001), with an overall response rate (ORR) of 89% (vs. 74% in the R2 group), a complete response (CR) rate of 74% (vs. 43% in the R2 group), and a median progression-free survival (PFS) that was not reached (vs. 11.2 months in the R2 group). The safety profile of EPKINLY + R2 was consistent with the known safety characteristics of each individual agent, with the most common adverse reactions including rash, upper respiratory tract infections, fatigue, injection site reactions, constipation, diarrhea, cytokine release syndrome (CRS), pneumonia, COVID-19, and fever. CRS occurred in 24% of patients, primarily of low grade. Additionally, based on the Phase 3 data, the FDA converted EPKINLY’s prior accelerated approval for R/R FL to full approval. Data from the study will be presented at the 2025 American Society of Hematology (ASH) Annual Meeting and Exposition in December, and AbbVie plans to pursue additional international regulatory approvals for this indication. FL is an indolent form of non-Hodgkin lymphoma, with approximately 15,000 new cases diagnosed annually in the U.S. It is currently incurable, prone to recurrence, and some patients may develop transformed aggressive diffuse large B-cell lymphoma (DLBCL). This chemotherapy-free, outpatient-administered combination therapy provides a new treatment option for these patients.
3.BMS & J&J Stop Librexia ACS Trial (No New Safety Issues); AF/Secondary Stroke Prevention Trials On Track for 2026 Readout
Bristol Myers Squibb and Johnson & Johnson jointly announced the discontinuation of the Phase 3 Librexia ACS clinical trial, which aimed to evaluate the efficacy and safety of the investigational drug milvexian in combination with standard-of-care conventional antiplatelet therapy for patients with recent acute coronary syndrome (ACS); the decision to discontinue comes after the Independent Data Monitoring Committee (IDMC) determined in a preplanned interim analysis that the trial is unlikely to meet its primary efficacy endpoint, with no new safety concerns related to milvexian identified and its safety profile consistent with previous studies. The other two Phase 3 trials in the Librexia clinical program—Librexia AF for atrial fibrillation (AF) and Librexia STROKE for secondary stroke prevention (SSP)—will proceed as planned, with topline data expected in 2026. Both companies remain fully confident in milvexian’s potential to redefine anticoagulant therapy for thrombotic diseases, believing that the factor XIa inhibition mechanism holds promising prospects, and noting that the aforementioned trials differ from Librexia ACS in several aspects. The study data will be shared at a future medical congress, and the two companies also express their gratitude to the patients, investigators, and clinical trial sites that participated in the Librexia ACS trial.
Link：https://news.bms.com/news/corporate-financial/2025/Update-on-Phase-3-Librexia-ACS-Trial/default.aspx
4.New long-term data reinforces TREMFYA (guselkumab) as the only IL-23 inhibitor proven to substantially inhibit structural joint damage in active psoriatic arthritis®
On November 17, 2025, Johnson & Johnson presented 48-week long-term data from the Phase 3b APEX study at the 2025 Inflammatory Skin Disease Summit (ISDS), showing that TREMFYA (guselkumab) – the only IL-23 inhibitor proven to substantially inhibit structural joint damage in active psoriatic arthritis (PsA) – demonstrated 2.5 times greater inhibition of joint structural damage versus placebo at Week 24 (consistent results in both the every four weeks [Q4W] and every eight weeks [Q8W] dose groups), with this effect sustained through Week 48; patients in the placebo group who switched to TREMFYA at Week 24 experienced a 57% reduction in the rate of radiographic progression (from 0.96 at baseline to Week 24 to 0.41 from Week 24 to 48) as measured by the mean change in the PsA-modified van der Heijde-Sharp (vdH-S) score. Additionally, TREMFYA showed significant clinically meaningful improvements in American College of Rheumatology 50 (ACR50) response rates, which continued to increase from Week 24 to Week 48 in both dose groups, while nearly half of patients in the placebo-switch group achieved ACR50 by Week 48. The safety profile of TREMFYA was consistent with its well-established characteristics, with no new safety signals identified. As the first and only fully human, dual-acting monoclonal antibody approved for the treatment of PsA that blocks IL-23 while binding to CD64 (a receptor on IL-23-producing cells), TREMFYA’s data supported Johnson & Johnson’s recent submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA), seeking approval to include new evidence in the TREMFYA label regarding its inhibition of structural damage progression in adults with active PsA.
5.Sanofi’s Teizeild recommended for EU approval by the CHMP for patients with stage 2 type 1 diabetes
On November 14, 2025, Sanofi announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the approval of Teizeild (teplizumab) for delaying the progression to stage 3 type 1 diabetes (T1D) in patients aged 8 years and older with stage 2 T1D. Supported by data from the phase 2 TN-10 study, Teizeild significantly delayed the onset of stage 3 T1D by a median of approximately two years (59.6 months vs. 24.4 months) compared to placebo, with 57% of patients remaining in stage 2 (vs. only 28% in the placebo group), and its safety profile was consistent with previous studies. If approved, Teizeild will become the first disease-modifying therapy for T1D in the EU. Already authorized in multiple countries including the U.S. and China, it is the world’s first and only treatment targeting the autoimmune mechanism of T1D.
Link：https://www.sanofi.com/en/media-room/press-releases/2025/2025-11-14-11-30-00-3188166
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