On August 23, 2026 Orum Therapeutics ("Orum" or the "Company") (KRX: 475830), a biotechnology company pioneering the field of degrader-antibody conjugates (DACs), reported that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for ORM-1153, a CD123-GSPT1 DAC. Orum plans to initiate a first-in-human Phase 1 study of ORM-1153 in patients with relapsed or refractory acute myeloid leukemia (AML) and other hematologic malignancies by the end of 2026.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"FDA clearance of the IND for ORM-1153 is an important milestone for Orum, bringing another first-in-class DAC into the clinic and extending our approach into CD123-expressing hematologic malignancies," said Olaf Christensen, M.D., Chief Medical Officer of Orum Therapeutics. "By combining cell-selective delivery with targeted protein degradation in a single molecule, we believe ORM-1153 has the potential to improve treatment efficacy and tolerability for patients with severe hematologic malignancies."

ORM-1153 uses Orum’s TPD² approach to deliver a GSPT1 degrader payload to CD123-expressing cells, enabling targeted degradation of GSPT1. In preclinical studies presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026, ORM-1153 demonstrated broad activity across AML models, including activity in primary AML patient samples and TP53-relevant models, as well as low-dose in vivo activity and favorable repeat-dose tolerability.

The first-in-human Phase 1 study will assess the safety and tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of ORM-1153 in patients with relapsed or refractory AML and other hematologic malignancies. The multicenter study is expected to enroll approximately 42 patients initially at U.S. clinical sites, with potential expansion to other regions.

Orum will host a conference call on Monday, August 24, at 7:00 a.m. KST (Sunday, August 23, at 6:00 p.m. EDT) to discuss the ORM-1153 IND clearance and provide a high-level overview of the Phase 1 clinical study. Conference call details are available at View Source

About Orum’s TPD² Approach

Orum’s unique Dual-Precision Targeted Protein Degradation (TPD²) approach builds novel targeted protein degraders combined with the precise cell delivery mechanisms of antibodies to generate innovative, first-in-class, cell-selective TPDs for the treatment of cancer and other serious diseases. Orum has developed new targeted protein degrader payloads to specifically degrade an intracellular target protein within cancer cells via the E3 ubiquitin ligase pathway. Conjugated to antibodies, the payloads are designed to be delivered specifically to target cells and precisely degrade the intracellular target protein of interest.

(Press release, Orum Therapeutics, AUG 23, 2026, View Source [SID1234670284])

On August 23, 2026 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune diseases, solid tumors and hematological malignancies, reported an overview of its interim results for the period ended June 30, 2026, which were announced on August 21, 2026, together with recent business highlights and strategic progress.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. Jay Mei, Antengene’s Founder, Chairman, and CEO, said, "In H1 2026, Antengene achieved its first‑ever profitability, with total revenue of RMB 513 million, representing a year‑on‑year increase of 864.5%, and profit for the period of RMB 216 million. This is an important validation of our strategy to create value through internal innovation and global partnerships. The successful execution of our partnering strategy is translating the strength of our pipeline into meaningful financial returns. Most notably, our global exclusive license agreement with UCB for ATG‑201 (CD19 x CD3 T‑cell engager [TCE]) generated a USD 60 million upfront payment. We also entered into an exclusive license agreement with K2 Therapeutics, established by MPM BioImpact, for ATG‑106 (first‑in‑class CDH6 x CD3 TCE), under which the aggregate upfront and near‑term consideration amounts to approximately USD 20 million. Together with potential milestone payments and tiered royalties from these partnerships, as well as commercial revenue from XPOVIO, these revenue streams further strengthen our financial position and expand our capacity to invest in innovation.

Our late-stage clinical program ATG‑022 (CLDN18.2 antibody‑drug conjugate [ADC]) has received CDE Breakthrough Therapy Designation, demonstrating strong efficacy and best-in-class safety in gastric cancer across all levels of CLDN18.2 expression, as well as in other CLDN18.2+ solid tumors. We are advancing two key clinical studies in gastric cancer: the CLINCH‑2 study, evaluating ATG‑022 in combination with chemotherapy and an anti‑PD‑1 antibody in the 1L treatment of patients with gastric or gastroesophageal junction adenocarcinoma (GC/GEJC) with CLDN18.2 IHC 1+ ≥ 1%; and the pivotal Phase III CLINCH‑3 study evaluating ATG-022 monotherapy for GC/GEJC patients with CLDN18.2 IHC 2+ ≥ 20%. We are confident in the potential of ATG-022 to benefit a broad population of patients with CLDN18.2-expressing tumors and believe it is well positioned to become a cornerstone of our pipeline and one of our most important future value drivers.

In TCE innovation, we continue to expand our capabilities beyond our established AnTenGager TCE platform. We have successfully developed and newly launched TriGager, our next generation logic-gated tri-specific TCE platform, together with new TCE formats incorporating costimulatory moieties, further broadening our comprehensive TCE engineering toolbox. We are also deepening the integration of AI across our R&D engine. By linking multi-omics analysis with internally generated protein datasets, our AI platform identifies novel targets and target combinations, informs molecular design, and optimizes antibody developability. The platform has already contributed to the nomination of ATG-115, a T-cell engager (TCE) for hepatocellular carcinoma (HCC) directed at a novel, AI-identified tumor-associated antigen. AI-enabled combinatorial screening has also surfaced multiple novel target pairs now advancing toward future TriGager programs. Combined with the differentiated engineering of our AnTenGager and TriGager platforms, AI expands the range of molecules we can design for diseases of high unmet medical need.

Beyond these programs, we are advancing the next wave of internally generated innovation. ATG-125, our B7-H3 x PD-L1 bispecific ADC, has demonstrated encouraging preclinical efficacy, with an IND submission planned for Q1 2027. ATG-207, our first-in-class αCD3-TGF-β bifunctional fusion protein, represents a differentiated approach to restoring immune tolerance in T cell-mediated autoimmune disease. ATG‑112, our first‑in‑class ALPPL2 × CD3 TCE, targets gynecological tumors, digestive system malignancies, bladder cancer and NSCLC. ATG‑110, our LY6G6D × CD3 TCE, targets IO‑resistant microsatellite‑stable colorectal cancer. Together, these programs highlight the breadth of our innovation and represent potential future value drivers across oncology and autoimmune diseases.

As Antengene enters its next stage of development, we will continue to strengthen our R&D capabilities, advance our clinical pipeline and deepen global partnerships. With sustained innovation and a stronger financial position, we are well positioned to execute our strategy and create long‑term value."

1.ATG-022（CLDN18.2 ADC）

Latest data from the Phase II CLINCH study: As of June 26, 2026, among patients with moderate to high CLDN18.2 expression (IHC 2+ ≥ 20%), the 2.4 mg/kg dose cohort achieved an objective response rate (ORR) of 42.4% (14/33) and a disease control rate (DCR) of 90.9% (30/33), with a median overall survival (mOS) of 12.85 months. In the 1.8 mg/kg dose cohort, the ORR was 46.7% (14/30), the DCR was 86.7% (26/30), and the mOS had not yet been reached after a median follow‑up of 14.03 months. Among patients with low/ultra-low CLDN18.2 expression treated at the efficacious dose range of 1.8-2.4 mg/kg, the ORR was 28.6% (6/21) and the DCR was 52.4% (11/21). In addition, one patient in each of the three cohorts achieved a complete response (CR). These results demonstrated the robust anti-tumor activity of ATG-022 across all levels of CLDN18.2 expression.
Favorable safety profile: Compared with the data cutoff of December 25, 2025, the incidence of Grade ≥3 treatment‑related adverse events (TRAEs) in the 1.8 mg/kg dose cohort increased slightly from 19.4% to 21.0%, with only 9.7% of patients experiencing dose reduction due to TRAEs. Despite more than six additional months of treatment exposure and follow‑up, the incidence of Grade ≥3 TRAEs remained broadly stable in the 1.8 mg/kg dose cohort. This favorable safety profile supports the continued development of ATG‑022 in combination with chemotherapy and an anti-PD-1 antibody in the 1L setting, further expanding its therapeutic potential.
mOS not yet reached in the 1.8 mg/kg dose cohort: After a median follow‑up of 14.03 months, mOS had not yet been reached in the 1.8 mg/kg dose cohort, further supporting the potential for durable clinical benefit with ATG-022.
Three Complementary Development Paths Position ATG-022 for Near-Term Registration, 1L Leadership, and Broader Patient Reach: CLINCH-3 provides a near-term registration pathway for ATG-022 monotherapy at the optimized 1.8 mg/kg dose in 3L+ gastric/GEJ cancer with CLDN18.2 IHC 2+ ≥ 20%, establishing ATG-022 in gastric cancer. CLINCH-2 is evaluating ATG-022 in 1L in combination with standard-of-care chemotherapy and anti-PD-1 therapy, targeting the broadest CLDN18.2-positive population starting from IHC 1+ ≥ 1%, with the goal of supporting 1L registration and unlocking the full potential of ATG-022 in gastric cancer. Meanwhile, the CLINCH basket trial is expanding ATG-022 beyond gastric cancer, with encouraging efficacy already observed in a gynecological tumor subtype and other CLDN18.2-positive solid tumors.
2. AnTenGager & TriGager TCE Platforms

There is no one-size-fits-all approach to designing TCE molecules across different targets and indications. Achieving optimal balance between efficacy and safety requires tailoring each molecule to the underlying target biology. To this end, Antengene has built a comprehensive TCE engineering toolbox comprising its proprietary AnTenGager and TriGager platforms, together with multiple functional modules. This modular system enables Antengene’s R&D team to customize molecular formats and designs for different targets, improving development efficiency while supporting differentiated clinical strategies.

AnTenGager TCE platform: AnTenGager is Antengene’s proprietary, second-generation TCE platform featuring "2+1" bivalent binding format for low-expressing targets, steric hindrance masking, and proprietary CD3 sequences with fast on/off kinetics to minimize cytokine release syndrome (CRS) and enhance efficacy. These differentiated features support the platform’s broad applicability across autoimmune diseases, solid tumors and hematological malignancies indications. Leveraging this platform, Antengene has built a pipeline of multiple drug candidates, two of which have entered into exclusive out-licensing agreements:
ATG-201 (CD19 x CD3 TCE): Antengene entered into a global exclusive license agreement with UCB. The Company has received USD 60 million upfront payment from UCB to date and is eligible to receive an additional USD 20 million near‑term milestone payment, up to approximately USD 1.1 billion in additional milestone payments, as well as tiered royalties on future net sales. ATG‑201 has obtained approvals from China’s National Medical Products Administration (NMPA) to initiate the Phase I ATTRACT study for the treatment of B cell related autoimmune diseases.
ATG-106 (first-in-class CDH6 x CD3 TCE): Antengene entered into an exclusive license agreement with K2 Therapeutics, a company established by MPM BioImpact. The aggregate upfront and near‑term considerations amounts to approximately USD 20 million. We are also eligible to receive up to USD 960.5 million in additional milestone payments, as well as tiered royalties on future net sales. The Company plans to submit an IND application for ATG-106 in H1 2027.
TriGager TCE platform: TriGager is Antengene’s proprietary tri‑specific TCE platform incorporating steric hindrance masking technology and supporting multiple logic-gated formats, including AND‑Gate, True AND‑Gate and OR‑Gate. AND‑Gate and True AND‑Gate molecules require target cells to co‑express two disease‑associated antigens before T‑cell‑mediated cytotoxicity can be triggered. This mechanism improves target specificity, reduces on-target-off-tumor toxicity, and expands the pool of druggable targets for TCE modalities. In contrast, OR‑Gate molecules trigger T‑cell‑mediated killing upon recognition of either one of the disease‑associated antigens, helping address heterogeneity in target expression. The platform also supports the incorporation of an engineered CD2 co‑stimulatory moiety, which optimizes molecular developability, enhances TCE potency, and mitigates the risk of CRS, further optimizing the balance between efficacy and safety.
3. Next Generation ADCs and Other Novel Programs

ATG-125 (B7-H3 x PD-L1 bispecific ADC): ATG-125 is an "IO + ADC" dual-function molecule targeting B7-H3 and PD-L1, integrating the direct cytotoxic activity of an ADC with the durable immune activation of IO therapies. By simultaneously blocking B7-H3- and PD-L1-mediated immunosuppressive signaling, ATG-125 effectively activates T cells and induces immunological memory. Preclinical studies demonstrate that the bispecific ADC delivers superior in vivo efficacy compared with single-target ADC approaches. The Company plans to submit an IND application for ATG-125 in Q1 2027.
ATG-207 (αCD3-TGF-β Bifunctional Fusion Protein): ATG-207 is a globally first-in-class αCD3-TGF-β bifunctional fusion protein being developed for the treatment of T cell–mediated autoimmune diseases. The Company first disclosed its preclinical data at the 2026 European Congress of Rheumatology (EULAR 2026).
【Highlights of Financial Results】

As of the end of the reporting period, the Company recorded total revenue of RMB 513 million for H1 2026, representing a year‑on‑year increase of 864.5%. Profit for the period stood at RMB 216 million, marking the Company’s first profitable period.
As of June 30, 2026, the Company held cash and bank balances of RMB 765 million. In addition, under the license agreement with UCB, the Company received license revenue of approximately RMB 195 million from UCB in July 2026. The Company is also eligible to receive a near‑term milestone payment of approximately RMB 136 million.
To learn more about the 2026 interim results, please see the full announcement in the "Investor Relations" section on the company’s website.

(Press release, Antengene, AUG 23, 2026, View Source [SID1234670285])

On August 23, 2026 Anbogen Therapeutics Inc. (TPEx: 7784) ("Anbogen" or the "Company"), a clinical-stage precision oncology company, reported that it has entered into a Collaborative Research Agreement (CRA) with the Laboratory of Veterinary Surgery, Graduate School of Agricultural and Life Sciences, The University of Tokyo, to evaluate ABT-301 (Imofinostat), the Company’s selective Class I histone deacetylase inhibitor (HDACi), across multiple solid tumor types (including osteosarcoma, melanoma, soft tissue sarcoma, bladder cancers and other refractory solid tumors) using established veterinary oncology models.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The collaboration will be led by Lecturer Daiki Kato, Professor Takayuki Nakagawa, and Professor Manabu Mochizuki, Director of the Affiliated Veterinary Medical Center, The University of Tokyo. The research team brings extensive expertise in translational oncology, cancer immunotherapy, and genomic medicine in companion animals, and operates one of Asia’s most comprehensive comparative oncology platforms.

Accelerating Human Clinical Development Through Comparative Oncology

The primary strategic objective of this collaboration is to generate the scientific evidence required to support the expansion of ABT-301’s human clinical indications and to optimize the compound’s combination strategies ahead of future clinical trials. Naturally occurring cancers in dogs are widely recognized as clinically and molecularly analogous to their human counterparts. Among these, canine osteosarcoma represents one of the most extensively studied comparative oncology models due to its remarkable biological and clinical similarities to human osteosarcoma. Insights generated from this naturally occurring disease provide a unique opportunity to evaluate therapeutic strategies at disease stages that are often difficult to study in early human clinical development, making canine data directly informative for human clinical trial design, patient selection strategies, and regulatory submissions. Using The University of Tokyo’s proprietary preclinical models, the collaboration will evaluate ABT-301 as a monotherapy and in combination with other agents, with comprehensive mechanistic analyses to elucidate its mechanism of action and identify the molecular backgrounds most predictive of response. Findings will directly inform indication selection and combination regimen design for future human trials.

Dr. John Hsu, Chairman and CEO of Anbogen Therapeutics, said: "Comparative oncology is far more than animal research. It is a powerful platform for generating cross-species translational evidence that can bridge preclinical findings and human clinical development. Through this collaboration, we aim to evaluate ABT-301 in models that more closely reflect real-world disease biology, generating scientifically robust translational data to support future indication expansion and clinical development decisions. This strategic partnership will enable us to systematically assess ABT-301 across a broad range of difficult-to-treat solid tumors and extend its clinical potential beyond our current colorectal cancer program. The resulting evidence will be critical for designing and supporting the expansion of our ongoing human clinical development into new indications."

ABT-301 is currently being evaluated in a Phase I/II clinical trial in combination with anti-PD-1 and anti-VEGF in patients with pMMR/non-MSI-High metastatic colorectal cancer. As an isoform-selective Class I HDACi, ABT-301 is designed to modulate the tumor immune microenvironment and sensitize tumors to immune checkpoint inhibition where lies the potential applicability across immunologically cold solid tumors. Importantly, independent Phase III clinical studies evaluating other HDAC inhibitors in combination with immune checkpoint inhibitors have demonstrated significant synergistic efficacy in advanced cancers, including a marked improvement in progression-free survival (PFS). These external clinical findings provide strong proof-of-concept for the HDAC inhibitor–immune checkpoint inhibitor combination strategy and further support the clinical development of ABT-301 across multiple cancer indications.

Dr. Daiki Kato, The University of Tokyo, said: "Naturally occurring cancers in dogs and cats develop spontaneously under environmental and lifestyle conditions shared with humans and evolve through immune editing to acquire complex tumor immune microenvironments. These unique characteristics enable naturally occurring canine and feline cancer models to faithfully recapitulate key biological, immunological, and clinical features that are difficult to reproduce in conventional preclinical models. We believe this collaborative research will generate robust translational evidence to support the clinical development of ABT-301. Our research team is fully committed to maximizing the scientific impact of this collaboration and to providing the scientific evidence needed to support indication expansion and future clinical development of ABT-301."

About ABT-301 (Imofinostat)

ABT-301 is an orally available, selective Class I HDAC inhibitor designed to reverse immune evasion in solid tumors by enhancing antigen presentation and promoting anti-tumor immune activity. ABT-301 is currently being evaluated in a Phase I/II clinical trial in combination with anti-PD-1 and anti-VEGF therapy for the treatment of metastatic colorectal cancer. The Company believes that ABT-301’s mechanism of action has broad applicability across multiple immunotherapy-resistant solid tumor types.

(Press release, Anbogen Therapeutics, AUG 23, 2026, View Source [SID1234670286])

On August 21, 2026 Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, reported a strategic licensing and commercialization agreement with Lotus Pharmaceutical (TWSE Stock Code: 1795) covering two of Alvotech’s candidates in the United States and selected Asian markets: AVT34, a proposed biosimilar to Imfinzi (durvalumab), and AVT87, a proposed biosimilar to Hemlibra (emicizumab).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Imfinzi is an oncology biologic used in the treatment of multiple cancers, which generated global sales of approximately $6.1 billion in 2025¹. Hemlibra is a biologic for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A that generated global sales of approximately CHF4.8 billion (approximately $5.8 billion) in 2025².

Under a semi-exclusive agreement in the United States, Alvotech retains the right to commercialize both products directly alongside Lotus, while Lotus will commercialize the products through Alvogen, its U.S.-based wholly owned subsidiary. Alvotech will retain responsibility for product development, and for obtaining and maintaining marketing authorizations in the United States, and will serve as the exclusive supplier of the products for all markets.

In Asia, Lotus will have exclusive commercialization rights in eight selected markets: South Korea, Taiwan, Thailand, Vietnam, the Philippines, Singapore, Hong Kong and Malaysia. Lotus will be responsible for local regulatory submissions and commercialization in these markets.

The agreement has a potential value to Alvotech of up to approximately $150 million in upfront and milestone payments, in addition to ongoing revenues from the supply of commercial product.

"This agreement represents an important evolution of Alvotech’s commercial strategy," said Lisa Graver, Chief Executive Officer of Alvotech. "For the first time, we will have the opportunity to participate directly in the future commercialization of our products in the United States, allowing us to retain a greater share of the value we create through our development and manufacturing platform. At the same time, our partnership with Lotus extends the potential reach of these two important pipeline assets across key Asian markets. We look forward to working together to bring these medicines to patients and broaden access to high-quality biologics."

"We are pleased to partner with Alvotech on two important biosimilar candidates that meaningfully advance Lotus’ global growth strategy," said Petar Vazharov, Chief Executive Officer of Lotus. "By combining Alvotech’s integrated biosimilar development and manufacturing capabilities with Alvogen’s established U.S. commercial platform and Lotus’s deep market presence across Asia, we are building a strong foundation for the future commercialization of AVT34 and AVT87 across key global markets. These candidates expand the scale and reach of our biosimilar portfolio in oncology and rare diseases, and reinforces our commitment to broadening access to high-quality medicines."

Imfinzi and Hemlibra are registered trademarks and the property of their respective owners.

(Press release, Alvotech, AUG 21, 2026, View Source [SID1234670279])

On August 21, 2026 Johnson & Johnson reported that the European Commission (EC) has approved an indication extension for TECVAYLI (teclistamab) in combination with daratumumab for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have received at least one prior therapy. The approval introduces a new treatment option as early as second line for patients living with RRMM.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Complementary mechanisms of action underpin this immunotherapy doublet

Teclistamab and daratumumab work in a complementary manner, with daratumumab modulating the immune system to enhance T-cell fitness and activation, thereby amplifying teclistamab-mediated killing of myeloma cells.1,2

Expert and company perspectives on advancing the standard of care in RRMM

"Patients with relapsed or refractory multiple myeloma often experience shorter remissions and diminishing responses with each subsequent line of therapy, making earlier access to the most effective treatments increasingly important," said María-Victoria Mateos, M.D., Director of the Myeloma Unit at the University Hospital of Salamanca, Spain. "Today’s approval of teclistamab in combination with daratumumab marks an important advance by providing physicians with an off-the-shelf, steroid-sparing, immunotherapy option that has demonstrated meaningful improvements in progression-free and overall survival, with the potential to redefine treatment expectations as early as second line."

"This new indication for teclistamab plus daratumumab brings forward a new standard of care for patients in Europe living with relapsed or refractory multiple myeloma," said Ester in ‘t Groen, EMEA Therapeutic Area Head, Haematology, Johnson & Johnson. "By combining the complementary mechanisms of teclistamab, a BCMAxCD3 bispecific antibody, with daratumumab, a well-established standard of care that helps modulate the immune system, we can deliver meaningful long-term outcomes earlier in the treatment journey, where they have the greatest opportunity to influence the disease trajectory and redefine expectations for patients."

"Today’s approval reflects our ongoing commitment to addressing the diverse needs of patients with multiple myeloma, giving them more options at every stage of their disease," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "By continuing to invest in scientific innovation and practice-changing research, we aim to redefine what is possible for patients today, while moving closer to a future where long-term disease control, and ultimately cure, becomes an achievable goal."

Unprecedented Phase 3 study data demonstrate significant survival benefits versus standard of care, representing a potential new benchmark in RRMM

The EC approval is supported by data from the Phase 3 MajesTEC-3 study (NCT05083169), which evaluated the efficacy and safety of teclistamab plus daratumumab subcutaneous (SC) formulation versus investigator’s choice of daratumumab SC and dexamethasone with either pomalidomide or bortezomib (DPd/DVd) in patients with RRMM who have received 1–3 prior lines of therapy.3

Source: Costa L, et al. Teclistamab plus Daratumumab in Relapsed or Refractory Multiple Myeloma. The New England Journal of Medicine 2025; Full article and supplementary material. Available at: View Source Last accessed: August 2026.

The study demonstrated clinically meaningful and statistically significant improvements in both progression-free survival (PFS) and overall survival (OS).1 At nearly three years of follow-up, teclistamab plus daratumumab SC reduced the risk of disease progression or death by 83.4% compared to standard of care (hazard ratio [HR], 0.17; 95% confidence interval [CI], 0.12-0.23; p<0.001).1 More than 90% of patients who remained progression-free at six months (n=249) remained progression-free at three years, highlighting the durability of response observed with this regimen.1 OS favoured teclistamab plus daratumumab SC (HR, 0.46; 95% CI, 0.32-0.65; p<0.0001), with treatment benefit observed across all prespecified subgroups.1,2 At three years, OS rates were 83.3% for the combination compared with 65.0% for standard of care.1

Teclistamab combination demonstrated manageable safety profile

The safety profile of teclistamab plus daratumumab SC was consistent with the well-known profiles of the individual therapies and no new safety signals were identified.1,4,5 All cases of cytokine release syndrome were Grade 1/2 and did not lead to treatment discontinuation.1 Cytopenia and infection were the most commonly observed Grade 3/4 treatment-emergent adverse events (TEAEs).1 Treatment discontinuations due to TEAEs were low and occurred at similar rates between study arms (4.6% [teclistamab] vs. 5.5% [DPd/DVd]).1

About the MajesTEC-3 Study

MajesTEC-3 (NCT05083169) is an ongoing, Phase 3 randomised study evaluating the safety and efficacy of teclistamab plus daratumumab subcutaneous (SC) (n=291) versus investigator’s choice of daratumumab SC and dexamethasone with either pomalidomide or bortezomib (n=296) (DPd/DVd) in patients with relapsed/refractory multiple myeloma (RRMM) who have received 1–3 prior lines of therapy.1,3 The primary endpoint is progression-free survival (PFS) and secondary endpoints include complete response or better (≥CR), overall response rate (ORR), minimal residual disease (MRD) negativity (10⁻⁵ by next-generation sequencing), overall survival (OS), time to worsening of symptoms (MySIm-Q), and safety.3 The MajesTEC-3 study is a part of the MajesTEC clinical programme, which includes exploring the potential of teclistamab as a combination regimen.3

About Teclistamab

Teclistamab received European Commission (EC) approval in August 2022 for the treatment of patients with RRMM who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy.6 In August 2023, the EC approved a Type II variation application for teclistamab, providing the option for a reduced dosing frequency of 1.5mg/kg every two weeks in patients who have achieved a complete response (CR) or better for a minimum of six months.7

Teclistamab is an off-the-shelf (or ready-to-use) bispecific antibody.4,8 Teclistamab, a subcutaneous injection, redirects T-cells through two cellular targets (BCMA and CD3) to activate the body’s immune system to fight cancer.1,5 Teclistamab is currently being evaluated in several combination studies.4,9,10,11

To date, more than 30,700 patients have been treated worldwide with teclistamab.12

For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using teclistamab, please refer to the Summary of Product Characteristics at: View Source

In line with EMA regulations for new medicines and those given conditional approval, teclistamab is subject to additional monitoring.4

About Daratumumab and Daratumumab SC

Johnson & Johnson is committed to exploring the potential of daratumumab for patients with multiple myeloma across the spectrum of the disease.

In August 2012, Janssen Biotech, Inc., a Johnson & Johnson company, and Genmab A/S entered a worldwide agreement, which granted Johnson & Johnson an exclusive licence to develop, manufacture and commercialise daratumumab. Since launch, daratumumab has become a foundational therapy in the treatment of multiple myeloma, having been used in the treatment of more than 830,000 patients worldwide.13 Daratumumab was the first CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma.5,14 Daratumumab SC was also the first oncology injectable approved for administration by patients living with multiple myeloma or their caregivers from the fifth dose, if determined to be appropriate by their healthcare professional and following proper training.5,15 Daratumumab SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE drug delivery technology.5

CD38 is a surface protein that is present in high numbers on multiple myeloma cells, regardless of the stage of disease.5,16 Daratumumab binds to CD38 and inhibits tumour cell growth causing myeloma cell death.5 Daratumumab may also have an effect on normal cells.5 Data across ten Phase 3 clinical trials, in both the frontline and relapsed settings across all newly diagnosed multiple myeloma patients, have shown that daratumumab-based regimens resulted in significant improvement in progression-free survival and/or overall survival.17,18,19,20,21,22,23,24,25,26

For further information on daratumumab, please see the Summary of Product Characteristics at: View Source

About Multiple Myeloma

Multiple myeloma is a complex blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.27,28 In multiple myeloma, these malignant plasma cells continue to proliferate, accumulating in the body and crowding out normal blood cells, as well as often causing bone destruction and other serious complications.29,30 In the European Union, it is estimated that more than 35,000 people were diagnosed with multiple myeloma in 2024, and more than 21,900 patients died.31 Patients living with multiple myeloma experience relapses which become more frequent with each line of therapy, while remissions become progressively shorter.32,33,34 Whilst some patients with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, fatigue, high calcium levels, infections, or kidney damage.

(Press release, Johnson & Johnson, AUG 21, 2026, View Source [SID1234670280])