1. Omalizumab increased the tolerance to food allergens in patients experiencing allergic reactions
On March 02, 2025, Roche announced results from a phase III OUtMATCH study evaluating Xolair® (omalizumab) to treat one or more food allergies. Omalizumab can block IgE to reduce allergic reactions. In stage 2, the study met its primary endpoint, with 36% of food allergy patients treated with Xolair could tolerate at least 2,000 mg of peanut protein and two other food allergens without experiencing an allergic reaction, compared to 19% in the oral immunotherapy group. In stage 3, allergenic foods will be introduced to patients’ diets after stopping the drug.
Link: https://www.roche.com/media/releases/med-cor-2025-03-02
2. Sotyktu improved psoriatic arthritis symptoms, meeting primary and secondary endpoints
On March 08, 2025, BMS announced results from the Phase 3 POETYK PsA-2 trial evaluating the efficacy and safety of Sotyktu (deucravacitinib) in adults with active psoriatic arthritis (PsA). The study met its primary endpoint with 54.2% of patients receiving Sotyktu achieving at least 20% improvement compared to 39.4% of the placebo arm. Treatment with Sotyktu also met important secondary endpoints, demonstrating improvement across clinical signs and symptoms, extra-articular manifestations and patient-reported outcomes. The drug was previously approved in multiple countries for another autoimmune-related disorder, moderate-to-severe plaque psoriasis.
Link: https://news.bms.com/news/corporate-financial/2025/Bristol-Myers-Squibb-Presents-Late-Breaking-Data-from-Phase-3-POETYK-PsA-2-Trial-Demonstrating-Superiority-of-Sotyktu-deucravacitinib-Compared-with-Placebo-in-Adults-with-Psoriatic-Arthritis/default.aspx
3. Oral icotrokinra improved patients’ plaque psoriasis condition
On March 08, 2025, J&J announced data from a Phase 3 ICONIC-LEAD study evaluating the effects of an oral drug icotrokinra in plaque psoriasis patients compared to the injectable biologic, ustekinumab. Icotrokinra is an oral peptide selectively inhibiting the IL-23 receptor. At week 16, nearly two-thirds (65%) of patients treated with once daily icotrokinra achieved an Investigator’s Global Assessment (IGA) score of 0/1 (clear or almost clear skin), and 50% achieved a Psoriasis Area and Severity Index (PASI) 90 response, compared to 8% and 4% receiving placebo, respectively. While at Week 24, 74% of patients in the icotrokinra arm achieved IGA 0/1, and 65% achieved PASI 90.
Link: https://www.jnj.com/media-center/press-releases/icotrokinra-results-show-potential-to-set-a-new-standard-of-treatment-in-plaque-psoriasis
4. Imfinzi-based regimen improved event-free and overall survival in resectable gastric and GEJ cancers
On March 07, 2025, Astra Zeneca announced results from the MATTERHORN Phase III trial where patients were first treated with neoadjuvant Imfinzi in combination with chemotherapy before surgery, followed by adjuvant Imfinzi in combination with chemotherapy, and then Imfinzi monotherapy. The trial evaluated this regimen versus perioperative chemotherapy alone for patients with resectable, early-stage and locally advanced gastric and gastroesophageal junction (GEJ) cancers. In the trial, both the primary endpoint of event-free survival and the secondary endpoint of overall survival were achieved with the Imfinzi-based regimen.
Link: https://www.astrazeneca.com/media-centre/press-releases/2025/imfinzi-improved-efs-in-early-stage-gastric-cancer.html
5. EBGLYSS maintained long-term efficacy in moderate-to-severe atopic dermatitis
On March 7, 2025, Eli Lily and Company clinical results regarding EBGLYSS (lebrikizumab-lbkz) to treat patients with moderate-to-severe atopic dermatitis (AD) at three years. EBGLYSS selectively blocks IL-13 which is a primary cytokine in AD. Patients received once-monthly maintenance dosing if they responded to the treatment at Week 16. At three years, 50% of patients achieved complete skin clearance (EASI 100 or IGA 0) and 87% achieved or maintained almost-clear skin (EASI 90). In patients previously treated with Dupixent (dupilumab) 75% achieved significant improvement in skin pain and 62% achieved significant improvement in itch at week 24.
Link: https://investor.lilly.com/news-releases/news-release-details/lillys-ebglyssr-lebrikizumab-lbkz-single-monthly-maintenance
6. Baricitinib showed significant scalp, eyebrow, and eyelash regrowth in severe alopecia areata
On March 8, 2025, Eli Lilly and Company and Incyte’s once-daily, oral baricitinib 4 mg and 2 mg improves hair regrowth on the scalp, eyebrows and eyelashes at Week 36 in patients with severe alopecia areata (AA). Baricitinib is a JAK inhibitor to mediate the immune response. AA is a chronic immune disorder and patients usually suffer from patchy hair loss on the scalp, face or other areas. At Week 36, 60.0% of patients receiving baricitinib 4 mg and 36.9% of patients receiving baricitinib 2 mg showed at least 50% improvement in their disease (as measured by SALT score) compared to 5.7% on placebo. 42.4% of patients receiving baricitinib 4 mg and 27.4% of patients receiving baricitinib 2 mg achieved 80% or more scalp hair coverage, compared to 4.5% on placebo. There were also improvements in both eyebrow and eyelash regrowth.
Link: https://investor.lilly.com/news-releases/news-release-details/lillys-baricitinib-delivered-high-rates-hair-regrowth
7. Rocatinlimab demonstrated efficacy in moderate-to-severe atopic dermatitis with both higher and lower doses
On March 8, 2025, Amgen and Kyowa Kirin announced results from the ongoing Phase 3 clinical trial program evaluating rocatinlimab targeting the OX40 receptor, in moderate to severe atopic dermatitis (AD). In the IGNITE study, at 24 week, 42.3% of patients in the higher dose group and 36.3% of patients in the lower dose group achieved ≥75% reduction, compared to 12.8% in the placebo group. There were also improvements in scores of other assessments on the disease conditions.
Link: https://www.amgen.com/newsroom/press-releases/2025/03/amgen-and-kyowa-kirin-provide-top-line-results-from-rocatinlimab-phase-3-ignite-study-in-adults-with-moderate-to-severe-atopic-dermatitis
8. Rusfertide reduced phlebotomy needs in polycythemia vera patients
On March 3, 2025, Takeda and Protagonist Therapeutics announced results for the Phase 3 VERIFY study, where phlebotomy-dependent patients with polycythemia vera (PV) were randomized to treatment with either rusfertide or placebo, as an add-on to the standard of care treatment. PV is a rare blood cancer where the bone marrow produces too many red blood cells, thickening the blood and potentially causing blood clots. The primary endpoint was achieved with 77% of the rusfertide-treated patients showing the clinical response of the absence of phlebotomy eligibility compared to the 33% within the placebo group. The key secondary endpoints were also achieved with the mean of 0.5 phlebotomies per patient in the rusfertide arm compared to 1.8 phlebotomies per patient in the placebo arm during weeks 0-32. Phlebotomy is a standard treatment for patients suffering from this disease.
Link: https://www.takeda.com/newsroom/newsreleases/2025/positive-topline-results-from-verify-study/
9. Updates of decisions from different regulatory bodies
Regulatory Body | Decision | Company | Drug | Indication | Supported data |
FDA | Drug Approval | BeiGene | TEVIMBRA® (tislelizumab-jsgr), in combination with platinum-containing chemotherapy | First-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (≥1). | RATIONALE-306 study: |
FDA | Acceptance of the supplemental Biologics License Application | Roche | Gazyva®/Gazyvaro® (obinutuzumab) | lupus nephritis | REGENCY study: Improved complete renal response |
FDA | Acceptance of the supplemental Biologics License Application | GSK | Depemokimab | maintenance treatment of asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) | SWIFT and ANCHOR trials: Primary endpoints were met |
EC | Drug Approval | BMS | Opdivo® (nivolumab) plus Yervoy® (ipilimumab) | Adult patients with unresectable or advanced hepatocellular carcinoma (HCC) | CheckMate -9DW study: The median OS was 23.7 months for Opdivo plus Yervoy compared to 20.6 months with the investigator’s choice of lenvatinib or sorafenib. Overall response rate (ORR) of 36.1% compared to 13.2% of patients treated with lenvatinib or sorafenib. |
EU CHMP | Recommendation for approval | AstraZeneca | Imfinzi (durvalumab) in combination with chemotherapy | Adults with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence and no epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements | AEGEAN trial: 32% reduction in the risk of recurrence, progression events or death versus neoadjuvant chemotherapy alone in patients treated with the Imfinzi-based perioperative regimen; Treatment with Imfinzi-based perioperative regimen before surgery resulted in a pathologic complete response rate of 17.2% versus 4.3% for patients treated with neoadjuvant chemotherapy alone; |
https://news.bms.com/news/corporate-financial/2025/Bristol-Myers-Squibb-Receives-European-Commission-Approval-for-Opdivo-nivolumab-plus-Yervoy-ipilimumab-for-the-First-Line-Treatment-of-Adult-Patients-with-Unresectable-or-Advanced-Hepatocellular-Carcinoma/default.aspx
https://www.roche.com/media/releases/med-cor-2025-03-05
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