Notizia - Recent Pharma, Healthcare and Biotech Happenings
Dec 11, 2025
The 2025 San Antonio Breast Cancer Symposium (SABCS), the world’s leading forum for breast cancer research, highlights cutting-edge progress across the full spectrum of breast cancer, from prevention and molecular biology to new therapies and survivorship. This year’s focus includes several emerging strategies to reduce toxicity and improve outcomes in HER2-positive, HER2-negative, and triple-negative breast cancer (TNBC).
TNBC, accounting for about 10–15% of invasive breast cancers, remains a difficult subtype due to the absence of hormone receptors and HER2 expression, limiting targeted options. SABCS 2025 spotlights advances aimed at addressing these gaps and improving care across disease stages. According to DelveInsight’s TNBC Market Insight, Epidemiology and Market Forecast ꟷ 2034, TNBC accounts for approximately 105,000 cases in the 7MM in 2024, underscoring the continued need for therapeutic advancement.
Leading biopharma companies, including AstraZeneca, Novartis, Pfizer, and Daiichi-Sankyo, are driving key scientific updates at SABCS 2025. Among the highlights, BioNTech and Bristol Myers Squibb drew strong attention with new interim data on pumitamig. The two companies entered a global strategic partnership in June 2025 to co-develop and co-commercialize this next-generation bispecific antibody across multiple solid tumors.
Click Here To Get the Article in PDF
Why are investors interested in this next-generation bispecific immunotherapy, Pumitamig (BNT327/BMS986545)?
Efficacy data: The interim analysis (data cut: October 1) included 74 patients treated in the first- or second-line setting for locally advanced or metastatic TNBC. In Cohort 1, 39 patients were evaluable for efficacy across both 1L and 2L therapy.
| Measure | Result |
| Confirmed ORR (cORR) | 61.5% |
| Unconfirmed ORR (uORR) | 71.8% |
| Disease control rate (DCR) | 92.3% |
| uORR: 15 mg/kg | 63.2% |
| uORR: 20 mg/kg | 80.0% |
| uORR: PD-L1 CPS ≥10 and PD-L1 CPS <10 | Comparable uORRs were seen in both PD-L1 subgroups, 70.6% |
| uORR: 1L and 2L | 76.5% and 68.2% |
| 9-month PFS | 59.3% |
Safety data:
Pumitamig is gaining attention as a next-wave bispecific immunotherapy, showing meaningful activity in advanced TNBC irrespective of PD-L1 expression, a hurdle that limits current checkpoint inhibitors. Supported by the first global TNBC dataset and expanding rapidly across 20+ clinical trials in 10+ solid tumors, the agent is also advancing through the ROSETTA program in multiple lung cancer settings, with two mid-stage SCLC studies reporting positive outcomes this year.
| Program | Indication | Milestones in 2025 and Beyond* |
| Pumitamig | 1L/2L SCLC | Global Phase II dose optimization data |
| 1L/2L TNBC | Global Phase II dose optimization data | |
| *According to BioNTech’s 3rd Quarter 2025 presentation. | ||
Momentum for this class is rising, following the rise of PD-L1/VEGF bispecifics such as ivonescimab, which drew industry attention after outperforming KEYTRUDA in lung cancer and prompted Merck’s USD 588 million upfront acquisition of LaNova Medicines’ LM-299. Despite advances in PD-L1 + chemotherapy mainly for PD-L1–high patients, many still relapse, and PD-L1–negative tumors remain heavily underserved, with chemotherapy as the default standard of care.
Apart from expansion in multiple indications, in the newly launched global phase III Rosetta Breast-01 trial, researchers are now focusing on patients with PD-L1 levels under 10%, effectively avoiding Merck’s Keytruda, which is only approved in the U.S. for use with chemotherapy in patients whose PD-L1 expression is 10% or higher. Interestingly, BioNTech and Bristol have chosen not to challenge Keytruda in the high PD-L1 expressor population with the Biotheus-originated program.
Article in PDF
Dec 11, 2025
The 2025 San Antonio Breast Cancer Symposium (SABCS), the world’s leading forum for breast cancer research, highlights cutting-edge progress across the full spectrum of breast cancer, from prevention and molecular biology to new therapies and survivorship. This year’s focus includes several emerging strategies to reduce toxicity and improve outcomes in HER2-positive, HER2-negative, and triple-negative breast cancer (TNBC).
TNBC, accounting for about 10–15% of invasive breast cancers, remains a difficult subtype due to the absence of hormone receptors and HER2 expression, limiting targeted options. SABCS 2025 spotlights advances aimed at addressing these gaps and improving care across disease stages. According to DelveInsight’s TNBC Market Insight, Epidemiology and Market Forecast ꟷ 2034, TNBC accounts for approximately 105,000 cases in the 7MM in 2024, underscoring the continued need for therapeutic advancement.
Leading biopharma companies, including AstraZeneca, Novartis, Pfizer, and Daiichi-Sankyo, are driving key scientific updates at SABCS 2025. Among the highlights, BioNTech and Bristol Myers Squibb drew strong attention with new interim data on pumitamig. The two companies entered a global strategic partnership in June 2025 to co-develop and co-commercialize this next-generation bispecific antibody across multiple solid tumors.
Why are investors interested in this next-generation bispecific immunotherapy, Pumitamig (BNT327/BMS986545)?
Efficacy data: The interim analysis (data cut: October 1) included 74 patients treated in the first- or second-line setting for locally advanced or metastatic TNBC. In Cohort 1, 39 patients were evaluable for efficacy across both 1L and 2L therapy.
| Measure | Result |
| Confirmed ORR (cORR) | 61.5% |
| Unconfirmed ORR (uORR) | 71.8% |
| Disease control rate (DCR) | 92.3% |
| uORR: 15 mg/kg | 63.2% |
| uORR: 20 mg/kg | 80.0% |
| uORR: PD-L1 CPS ≥10 and PD-L1 CPS <10 | Comparable uORRs were seen in both PD-L1 subgroups, 70.6% |
| uORR: 1L and 2L | 76.5% and 68.2% |
| 9-month PFS | 59.3% |
Safety data:
Pumitamig is gaining attention as a next-wave bispecific immunotherapy, showing meaningful activity in advanced TNBC irrespective of PD-L1 expression, a hurdle that limits current checkpoint inhibitors. Supported by the first global TNBC dataset and expanding rapidly across 20+ clinical trials in 10+ solid tumors, the agent is also advancing through the ROSETTA program in multiple lung cancer settings, with two mid-stage SCLC studies reporting positive outcomes this year.
| Program | Indication | Milestones in 2025 and Beyond* |
| Pumitamig | 1L/2L SCLC | Global Phase II dose optimization data |
| 1L/2L TNBC | Global Phase II dose optimization data | |
| *According to BioNTech’s 3rd Quarter 2025 presentation. | ||
Momentum for this class is rising, following the rise of PD-L1/VEGF bispecifics such as ivonescimab, which drew industry attention after outperforming KEYTRUDA in lung cancer and prompted Merck’s USD 588 million upfront acquisition of LaNova Medicines’ LM-299. Despite advances in PD-L1 + chemotherapy mainly for PD-L1–high patients, many still relapse, and PD-L1–negative tumors remain heavily underserved, with chemotherapy as the default standard of care.
Apart from expansion in multiple indications, in the newly launched global phase III Rosetta Breast-01 trial, researchers are now focusing on patients with PD-L1 levels under 10%, effectively avoiding Merck’s Keytruda, which is only approved in the U.S. for use with chemotherapy in patients whose PD-L1 expression is 10% or higher. Interestingly, BioNTech and Bristol have chosen not to challenge Keytruda in the high PD-L1 expressor population with the Biotheus-originated program.
