1. PADCEV + KEYTRUDA Before and After Surgery Cut Risk of Death by 50% in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer
On October 18, 2025, Pfizer and Astellas announced results from the Phase 3 EV-303 (KEYNOTE-905) trial showing that PADCEV (enfortumab vedotin) combined with KEYTRUDA™ (pembrolizumab), given before and after surgery, dramatically improved outcomes for patients with muscle-invasive bladder cancer (MIBC) who are ineligible for or declined cisplatin chemotherapy. The combination therapy reduced the risk of recurrence, progression, or death by 60% and the risk of death by 50% compared to surgery alone. At two years, 74.7% of patients receiving PADCEV plus KEYTRUDA remained event-free versus 39.4% with surgery alone. Moreover, the secondary endpoint of overall survival was also reduced by 50% the combination therapy arm as compared to surgery alone. An estimated 79.7% of patients were alive at two years relative to 63.1% of patients who received surgery only.
2. BRAFTOVI + MEKTOVI Showed High Median Survival in Treatment-Naïve BRAF V600E-Mutant Metastatic Lung Cancer
On October 19, 2025, Pfizer reported updated long-term results from the Phase 2 PHAROS trial evaluating the combination of BRAFTOVI (encorafenib) and MEKTOVI (binimetinib) in adults with metastatic non-small cell lung cancer (mNSCLC) with a BRAF V600E mutation. BRAFTOVI is an oral small molecule kinase inhibitor that targets BRAF V600E, and MEKTOVI inhibits MEK, both targeting the MAPK signalling pathway. In treatment-naïve patients, the median overall survival (OS) was 47.6 months and in previously treated patients, the median OS was 22.7 months. The four-year survival rates were 49% and 31% in the respective groups. Moreover, the objective response rate was 75% for treatment-naïve patients (n=59) and 46% for previously treated patients (n=39).
3. XTANDI Plus Leuprolide Reduced Risk of Death and Extended Survival in Non-Metastatic Hormone-Sensitive Prostate Cancer
On October 19, 2025, Pfizer and Astellas announced results from the Phase 3 EMBARK trial XTANDI® (enzalutamide), in combination with leuprolide and as monotherapy, in men with non-metastatic hormone-sensitive prostate cancer. Enzalutamide is an androgen receptor inhibitor blocking the androgen receptor signalling pathway. For the key secondary endpoint, XTANDI plus leuprolide reduced the risk of death by 40.3% compared to leuprolide alone. After eight years, 78.9% of men in the combination group were alive, compared with 69.5% in the leuprolide group. In addition, earlier data showed the combination improved metastasis-free survival (MFS) by 58%.
4. Vamikibart Improved Vision and Macular Thickness in Uveitic Macular Edema
October 17, 2025, Roche announced results from two Phase III trials, MEERKAT and SANDCAT, evaluating vamikibart, a potential first-in-class non-steroid treatment for uveitic macular edema (UME). Vamikibart is a monoclonal antibody that inhibits IL-6, a key mediator of inflammation in ocular diseases. Across both studies, vamikibart showed rapid and meaningful improvements in vision and macular thickness compared with sham procedures. In MEERKAT, vamikibart achieved statistically significant superiority in the primary endpoint, with 36.9% and 19.9% more patients gaining at least 15 letters in visual acuity versus sham in 1 mg and 0.25 mg dosage groups. While SANDCAT did not meet statistical significance for the primary endpoint, but still showed that more patients were improved. Both trials demonstrated consistent secondary benefits in best corrected visual acuity (BCVA) and central subfield thickness (CST).
Link: https://www.roche.com/media/releases/med-cor-2025-10-17b
5. Giredestrant Plus Everolimus Reduced Risk of Disease Progression in HER2-Negative Advanced Breast Cancer
On October 18, 2025, Roche announced positive results from the phase III evERA Breast Cancer study. Giredestrant in combination with everolimus significantly reduced the risk of disease progression or death by 44% and 62% in the intention-to-treat (ITT) and ESR1-mutated populations, respectively, compared with standard-of-care endocrine therapy plus everolimus. Giredestrant is a selective estrogen receptor degrader (SERD) that binds to and degrades the estrogen receptor. Median progression-free survival was 8.77 months versus 5.49 months in the intention-to-treat group and 9.99 versus 5.45 months in the ESR1-mutated subgroup. Early overall survival data also showed a positive trend. The oral giredestrant–everolimus combination offers a promising new treatment option for people with ER-positive, HER2-negative advanced or metastatic breast cancer.
Link: https://www.roche.com/media/releases/med-cor-2025-10-18
6. Pluvicto Plus Standard Therapy Reduced Risk of Disease Progression or Death in PSMA-Positive Metastatic Prostate Cancer
On October 19, 2025, Novartis presented new Pluvicto™ (lutetium (177Lu) vipivotide tetraxetan) data from the Phase III PSMAddition trial for patients with PSMA+ metastatic hormone-sensitive prostate cancer (mHSPC). Pluvicto combined with standard of care therapy, significantly improved radiographic progression-free survival. The combination reduced the risk of radiographic progression or death by 28% versus standard therapy alone. An early positive trend in overall survival was also observed with more patients achieving complete response (57.1% vs 42.3%) and a higher overall response rate (85.3% vs 80.8%). Pluvicto also delayed the progression to metastatic castration-resistant prostate cancer.
7. EMA Committee Issued Negative Opinion on Rezurock for Chronic Graft-Versus-Host Disease
On October 17, 2025, Sanofi announced that the EMA’s CHMP had issued a negative opinion on Sanofi’s application to approve Rezurock (belumosudil) for third-line treatment of adults and pediatric patients with chronic graft-versus-host disease (cGVHD). Rezurock blocks the Rho-associated coiled-coil kinase 2 (ROCK2) pathway, which helps to rebalance the immune system. cGVHD is a serious and often life-threatening complication affecting up to half of stem cell transplant recipients. The main reason for the refusal was that the study lacked a direct comparison with another active treatment, and patients received additional therapies, making it difficult to clearly determine the true effects of the Rezurock. Sanofi announced plans to request a re-examination of the decision.
Link: https://www.sanofi.com/en/media-room/press-releases/2025/2025-10-17-11-00-00-3168524
https://www.ema.europa.eu/en/medicines/human/EPAR/rezurock?
8. Imfinzi Improved Survival in Gastric Cancer and Reduced Recurrence in Bladder Cancer Across Two Phase III Trials
On October 17, 2025, AstraZeneca reported two major Phase III trial successes for Imfinzi (durvalumab) for gastric cancer and bladder cancer. In the MATTERHORN trial for resectable early gastric and gastroesophageal junction cancer, Imfinzi significantly improved patient outcomes. In the final overall survival analysis, results showed the Imfinzi and FLOT perioperative regimen reduced the risk of death by 22% compared with chemotherapy alone.
In the POTOMAC trial, Imfinzi combined with BCG therapy for one year in patients with high-risk, non-muscle-invasive bladder cancer reduced the risk of disease recurrence or death by 32% compared with BCG alone. At two years, approximately 87% of patients receiving the Imfinzi regimen were alive and disease-free versus 82% in the control group. These findings further support Imfinzi’s expanding role in early and localised cancers, reinforcing its potential as a foundational immunotherapy across multiple tumour types.
9. Enhertu Showed Strong Efficacy Before and After Surgery in Early HER2-Positive Breast Cancer
On October 18, 2025, AstraZeneca and Daiichi Sankyo announced two major Phase III trial results for Enhertu (trastuzumab deruxtecan) in HER2-positive early breast cancer. In the DESTINY-Breast11 trial, Enhertu given before surgery followed by THP (trastuzumab + pertuzumab + paclitaxel) achieved a pathologic complete response rate of 67.3%, compared with 56% for standard ddAC-THP chemotherapy. Furthermore, after surgery, 81.3% of patients who received neoadjuvant treatment with Enhertu followed by THP showed no or minimal residual invasive cancer (residual cancer burden [RCB] 0 + I) in the resected breast or lymph nodes, compared with 69.1% of patients in the standard treatment group.
In the DESTINY-Breast05 trial, Enhertu with trastuzumab emtansine (T-DM1) as a post-neoadjuvant treatment (after surgery) was compared with T-DM1 alone in high-risk patients with residual invasive breast cancer. Enhertu significantly reduced the risk of recurrence or death by 53% versus the comparator arm. At three years, 92.4% of patients in the Enhertu arm were alive and free of invasive disease, compared with 83.7% in the T-DM1 arm. Enhertu also significantly reduced the risk of disease recurrence or death by 53%. Together, these results reinforce Enhertu’s potential to redefine the standard of care for early-stage HER2-positive breast cancer, both in pre-surgical and post-treatment settings.
10. Datroway Reduces Risk of Progression or Death by 43% and Extended Survival in First-Line Metastatic Triple-Negative Breast Cancer
On October 19, 2025, AstraZeneca and Daiichi Sankyo announced positive results from the Phase III TROPION-Breast02 trial showing that Datroway (datopotamab deruxtecan) significantly improved both overall survival (OS) and progression-free survival (PFS) compared to chemotherapy as first-line treatment for patients with locally recurrent or metastatic triple-negative breast cancer (TNBC) who were not eligible for immunotherapy. Datroway reduced the risk of disease progression or death by 43% and the median PFS to 10.8 months versus 5.6 months with chemotherapy. It also improved median OS to 23.7 months compared with 18.7 months, showing a significant survival benefit over chemotherapy in this patient population. Moreover, Patients treated with Datroway experienced nearly double the objective response rate (62.5% vs 29.3%) and longer duration of response (12.3 vs 7.1 months).
11. Trodelvy Reduced Risk of Disease Progression or Death by 38% in First-Line Metastatic Triple-Negative Breast Cancer
On October 19, 2025, Gilead Sciences announced positive results from the Phase 3 ASCENT-03 trial showing that Trodelvy® (sacituzumab govitecan) significantly improved progression-free survival compared with chemotherapy in patients with metastatic triple-negative breast cancer (TNBC) who are not eligible for immunotherapy. As the primary endpoint, Trodelvy® reduced the risk of disease progression or death by 38%. Median PFS with Trodelvy® was 9.7 months versus 6.9 months for chemotherapy. Trodelvy® also demonstrated a longer duration of response with chemotherapy (12.2 months vs. 7.2 months).
12. Zongertinib Achieved 77% Response Rate with Durable Disease Control in Treatment-Naïve HER2-Mutant Lung Cancer
On October 17, 2025, Boehringer Ingelheim reported positive Phase Ib results from the Beamion LUNG-1 trial evaluating zongertinib in treatment-naïve patients with advanced HER2 (ERBB2)-mutant non-small cell lung cancer (NSCLC). The drug achieved a 77% confirmed objective response rate (ORR) and 96% disease control in patients, with 8% complete and 69% partial responses. Responses occurred rapidly, with a median time to response of 1.4 months. At the data cut-off, nearly half of patients remained on treatment, and six-month duration of response (DoR) and progression-free survival (PFS) rates were 80% and 79%, respectively. Given its strong efficacy and tolerability, zongertinib has received Breakthrough Therapy Designation from both the U.S. FDA and China’s CDE for first-line treatment of HER2-mutant NSCLC.
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