1. Lunsumio® and Polivy® combination demonstrates superior efficacy and progression-free survival in R/R large B-cell lymphoma compared to R-GemOx
On 20 June 2025, Roche presented results from the phase III SUNMO study investigating the combination of the subcutaneous Lunsumio® (mosunetuzumab, CD20xCD3 T cell engager) with Polivy® (polatuzumab vedotin, anti-CD79b ADC) in patients with relapsed or refractory (R/R) large B-cell lymphoma (LBCL) who are not eligible for transplant. The study assessed the efficacy of the combination therapy compared to the MabThera®/Rituxan® (rituximab), gemcitabine and oxaliplatin (R-GemOx).
The Lunsumio and Polivy combination demonstrated a 59% reduction in the risk of disease progression or death compared to R-GemOx at a median follow-up of 23.2 months. The progression-free survival (PFS) was 11.5 months compared to 3.8 months for R-GemOx. Meanwhile, patients receiving the combination therapy achieved 30% more objective response and 25% more complete response compared to the R-GemOx arm.
Link: https://www.roche.com/media/releases/med-cor-2025-06-20
2. Venetoclax plus azacitidine fails to improve overall survival in newly diagnosed higher-risk MDS
On 16 June 2025, Abbvie announced venetoclax in combination with azacitidine did not meet the primary endpoint of overall survival (OS) in the Phase 3 VERONA Trial, with a hazard ratio of 0.908 in treating patients with newly diagnosed higher-risk myelodysplastic syndrome (HR-MDS). MDS is a disorder characterised by ineffective production of blood cells in the bone marrow. Previously, in the Phase 1b stage, results showed favourable efficacy with the overall response rate of 80.4% and median OS of 26.0 months. As for other indications, the combination was approved to treat acute myeloid leukemia, and it won’t be affected by the new trial failure.
Link: https://news.abbvie.com/2025-06-16-AbbVie-Provides-Update-on-VERONA-Trial-for-Newly-Diagnosed-Higher-Risk-Myelodysplastic-Syndromes
3. Atogepant shows superior tolerability and efficacy over topiramate in migraine prevention
On 18 June 2025, AbbVie announced positive results from the Phase 3 TEMPLE trial evaluating the tolerability, safety and efficacy of atogepant (QULIPTA® / AQUIPTA®, CGRP receptor antagonist) compared to topiramate in adult patients with a history of four or more migraine days per month. The study met its primary endpoint, where only 12.1% of patients discontinued receiving atogepant due to adverse events, while there were 29.6% of patients occurred adverse events and stopped treatment in the topiramate arm.
The study also met all six secondary endpoints, and one measures the key clinical efficacy, where 64.1% of patients on atogepant achieved more than 50% reduction in mean monthly migraine days (MMD) during months 4 to 6 compared to 39.3% of patients on topiramate.
Link: https://news.abbvie.com/2025-06-18-AbbVie-Announces-New-Data-Demonstrating-Atogepant-QULIPTA-R-AQUIPTA-R-Achieves-Superiority-Across-All-Endpoints-in-Phase-3-Head-to-Head-Study-Compared-to-Topiramate-for-Migraine-Prevention
4. Breyanzi demonstrates high response and durable outcomes in relapsed or refractory marginal zone lymphoma
On 16 June 2025, BMS announced Phase 2 results evaluating Breyanzi (lisocabtagene maraleucel; liso-cel) in patients with relapsed or refractory marginal zone lymphoma (MZL). In the trial, patients are expected to receive liso-cel at a target dose of 100 x 106 CAR-positive viable T cells. Breyanzi is a CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain, which enhances the expansion and persistence of the CAR T cells.
The overall response rate (ORR) was 95.5%, with 62.1% of patients achieving a complete response (CR). With a median follow-up of 21.6, 23.8, and 24.5 months, respectively, the 24-month rates were 88.6% for duration of response, 85.7% for progression-free survival, and 90.4% for overall survival. Moreover, at 24 months, the estimated rates were 88.6% for duration of response, 85.7% for progression-free survival, and 90.4% for overall survival. These estimates are based on median follow-up times of 21.6 months for duration of response, 23.8 months for progression-free survival, and 24.5 months for overall survival.
Link: https://news.bms.com/news/corporate-financial/2025/Bristol-Myers-Squibb-Presents-First-Data-from-the-Marginal-Zone-Lymphoma-Cohort-of-the-Transcend-FL-Trial-Demonstrating-Deep-and-Durable-Responses-with-Breyanzi-lisocabtagene-maraleucel/default.aspx
5. Orforglipron meets primary endpoint in patients with type 2 diabetes and inadequate glycemic control
On 21 June 2025, Eli Lilly and Company announced results from ACHIEVE-1, a Phase 3 trial evaluating orforglipron compared to placebo in adults with type 2 diabetes and inadequate glycemic control. Orforglipron is the first oral small molecule and non-peptide GLP-1 receptor agonist. In the study, orforglipron significantly reduced A1C by 1.3% to 1.6% from a baseline of 8.0% at 40 weeks, meeting the primary endpoint. Up to 76.2% of participants reached an A1C below 7%, with 25.8% achieving normal A1C levels (<5.7%). Moreover, participants on the highest dose lost an average of 16.0 lbs (7.9%). While a weight plateau wasn’t observed in ACHIEVE-1, longer-term studies like ATTAIN will further assess orforglipron’s safety and efficacy in obesity treatment.
Link: https://investor.lilly.com/news-releases/news-release-details/lillys-oral-glp-1-orforglipron-showed-compelling-efficacy-and
6. Once-weekly insulin efsitora showed non-inferior A1C reduction compared to daily basal insulin
On 22 June 2025, Eli Lilly and Company announced results Phase 3 clinical trials evaluating the safety and efficacy of investigational once-weekly insulin efsitora alfa (efsitora) in adults with type 2 diabetes. Among the three trials, QWINT-1 focused on adults with type 2 diabetes who were starting insulin for the first time. QWINT-3 included those who had previously used daily basal insulin, while QWINT-4 involved individuals who had used both daily basal and mealtime insulin.
In each trial, once-weekly efsitora met the primary endpoint of non-inferior A1C reduction compared to daily basal insulin. In QWINT-1, efsitora reduced A1C by 1.31% at week 52, compared to 1.27% with insulin glargine. In this trial, efsitora was titrated across four fixed doses at four-week intervals. In QWINT-3, A1C dropped by 0.86% with efsitora versus 0.75% with insulin degludec at week 26. In QWINT-4, both efsitora and insulin glargine achieved a 1.07% reduction. In these two trials, efsitora was dosed using standard insulin adjustment based on glucose levels.
Link: https://investor.lilly.com/news-releases/news-release-details/lillys-once-weekly-insulin-efsitora-alfa-demonstrated-a1c
7. Subcutaneous and oral amycretin both show robust and dose-dependent weight loss in obesity
On 21 June 2025, Novo Nordisk announced the results of two clinical trials evaluating subcutaneous and oral amycretin in people with overweight or obesity. Subcutaneous amycretin led to substantial, dose-dependent weight loss over time. At 36 weeks, participants on 60 mg and 20 mg doses lost 24.3% and 22.0% of their body weight, respectively, compared to minimal changes with placebo. Lower doses over shorter durations also showed reductions, with 5 mg over 28 weeks resulting in a 16.2% weight loss and 1.25 mg over 20 weeks leading to a 9.7% loss. As for the once-daily oral amycretin Phase 1 trial, participants treated for 12 weeks lost 10.4% and 13.1% of body weight with doses up to 50 mg and 2×50 mg, respectively, compared to 1.2% with placebo. Meanwhile, there were no signs of weight loss plateau observed during the treatment period.
Link: https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916351
8. Higher-dosage form of Wegovy® shows enhanced weight loss in obesity management
On 21 June 2025, Novo Nordisk presented results from the phase 3b STEP UP trial of a higher dose of Wegovy® (semaglutide 7.2 mg) in people with obesity but without diabetes. At 72 weeks of the STEP UP trial, patients receiving semaglutide 7.2 mg and 2.4 mg achieved a 20.7% and 17.5% weight loss, respectively, compared to 2.4% with placebo. Moreover, 93.2% of participants on 7.2 mg and 92.5% on 2.4 mg achieved at least 5% weight loss, versus 35.7% with placebo. The company expects to submit the use of higher dosage for regulatory approval soon.
Link: https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916352
9. CagriSema delivers significant weight loss and BMI improvement in obesity
On 22 June 2025, Novo Nordisk announced REDEFINE 1 phase 3 data evaluating CagriSema plus lifestyle interventions for weight loss in adults with obesity or overweight. CagrSema combines semaglutide, a GLP-1 receptor with cagrilintide, a dual amylin and calcitonin receptor agonist that helps reduce food intake. At 68 week, CagriSema resulted in 22.7% of weight loss, and the placebo group showed a 2.3% of weight loss. In addition, 50.7% of obesity reached the threshold for non-obesity (BMI < 30 kg/m2), and only 10.2% in the placebo group reached this threshold.
Link: https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916353
10. Updates on the regulatory decisions
Company | Drug | Regulatory decisions | Target | Indication | Supported data |
Johnson & Johnson | IMBRUVICA® (ibrutinib) + rituximab, cyclophosphamide, doxorubicin, vincristine and prednisolone (ibrutinib + R-CHOP) alternating with R-DHAP (or R-DHAOx)* without ibrutinib, followed by ibrutinib monotherapy | CHMP positive recommendation | BTK protein inhibitor | Adult patients with previously untreated MCL who would be eligible for autologous stem cell transplant (ASCT) | Phase 3 TRIANGLE study: Adding ibrutinib to chemotherapy followed by a 2-year fixed-duration maintenance period instead of ASCT provides significantly longer overall survival and superior failure-free survival compared to the chemotherapy regimen including ASCT |
Johnson & Johnson | Subcutaneous DARZALEX® (daratumumab) | CHMP positive recommendation | Anti-CD38 antibody | Adult patients with smouldering multiple myeloma (SMM) at high-risk of developing multiple myeloma | Phase 3 AQUILA study: |
Bayer | Nubeqa™ (darolutamide) in combination with androgen deprivation therapy (ADT) | CHMP positive recommendation | Androgen receptor antagonist | Patients with metastatic hormone-sensitive prostate cancer (mHSPC) | Phase 3 ARANOTE study: |
Sanofi Regeneron | Dupixent (dupilumab) | FDA approval | Anti-IL-4Rα, inhibiting IL-4 and IL-13 pathway | Adult patients with bullous pemphigoid (BP) | Phase 2/3 ADEPT study: 18.3% achieved sustained disease remission vs. 6.1% (placebo); 38.3% achieved clinically meaningful itch reduction vs. 10.5% (placebo). |
Gilead Sciences | Yeztugo® (lenacapavir) | FDA approval | HIV-1 capsid inhibitor | Pre-exposure prophylaxis (PrEP) to prevent sexually acquired HIV in adults and adolescents ≥35kg | Phase 3 PURPOSE 1 and PURPOSE 2 study: Over 99.9% of participants receiving lenacapavir remained HIV negative. |
https://www.jnj.com/media-center/press-releases/darzalex-daratumumab-receives-the-first-positive-chmp-opinion-for-patients-with-high-risk-smouldering-multiple-myeloma
https://www.bayer.com/media/en-us/chmp-recommends-third-indication-for-bayers-nubeqa-darolutamide-for-patients-with-advanced-prostate-cancer/
https://www.sanofi.com/en/media-room/press-releases/2025/2025-06-20-05-00-00-3102518
https://www.gilead.com/news/news-details/2025/yeztugo-lenacapavir-is-now-the-first-and-only-fda-approved-hiv-prevention-option-offering-6-months-of-protection
Post comments