On July 23, 2026 Infinitopes, a clinical-stage biotechnology company developing precision, off-the-shelf therapeutic cancer vaccines for solid tumours, reported that the first patient has been dosed with ITOP1, the company’s lead investigational therapeutic cancer vaccine candidate.

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This marks the first clinical evaluation of Infinitopes’ Precision Immunomics platform, which combines large-scale immunopeptidomic antigen discovery with proprietary engineered viral vector technologies, to identify naturally presented tumour antigens capable of generating durable anti-tumour T-cell responses.

The VISTA study (Vaccination with ITOP1 in resectable oesophageal adenocarcinoma to evaluate Safety, Tolerability and Anti-tumour activity) is a multicentre, randomised, double-blind, placebo-controlled Phase 1/2a clinical trial conducted in partnership with the University of Oxford. The study will evaluate ITOP1 in patients with newly diagnosed, surgically resectable oesophageal and gastro-oesophageal junction adenocarcinoma (OAC).

Unlike alternative therapeutic vaccination approaches after surgery, VISTA investigates early treatment, while the primary tumour remains in situ. This neoadjuvant approach is designed to test whether earlier immune priming, in the presence of the patient’s tumour antigens, can generate stronger anti-tumour T-cell responses alongside standard-of-care treatment.

Current standard-of-care for resectable OAC consists of neoadjuvant FLOT / durvalumab chemoimmunotherapy, surgery, and adjuvant chemoimmunotherapy. In the VISTA protocol, ITOP1 is administered between chemoimmunotherapy and surgery, both before and after oesophagectomy, allowing investigators to evaluate vaccine-induced immune responses throughout first-line treatment.

Infinitopes’ Precision Immunomics platform identifies tumour antigens naturally presented by cancer cells through direct immunopeptidomic analysis, including both canonical and non-canonical targets. These antigens are incorporated into the company’s proprietary engineered viral vector platform, designed to generate potent and durable T-cell immunity against solid tumours.

Investigators will evaluate the safety and tolerability of ITOP1 together with vaccine-induced immune responses and exploratory biomarkers associated with anti-tumour activity and disease recurrence.

Professor Mark Middleton

Chief Investigator, VISTA Trial; Head of the Department of Oncology, University of Oxford; Consultant Medical Oncologist, Oxford University Hospitals NHS Foundation Trust

"The first patient dosed in VISTA is an important landmark for our programme and for the wider field of therapeutic cancer vaccines. The neoadjuvant setting provides a fantastic opportunity to study immune responses while the patient’s primary tumour is still there. VISTA is designed to determine if this approach safely generates meaningful anti-tumour immunity and can delay recurrence after standard treatment and surgery."

Dr Jonathan Kwok
Co-Founder, President and Chief Medical Officer, Infinitopes

"Entering the clinic is a defining milestone for successful future medicines. For Infinitopes, VISTA represents the first clinical evaluation of our integrated approach that combines Precision Immunomics target discovery with proven viral vectors, to engineer precise, off-the-shelf therapies for cancer patients.

"By identifying the antigens that are naturally presented by patients’ tumours, and delivering these using vectors designed to generate durable T-cell immunity, we believe this approach has the potential to build an exciting pipeline of future programmes across multiple solid tumours. We look forward to evaluating the safety and immunological signals from early 2027."

The Phase 1 safety lead-in will recruit eight participants, to evaluate safety, tolerability and vaccine-induced immunity, before continuing into the randomised, placebo-controlled Phase 2a stage enrolling an additional 52 participants.

Initial safety and immunological data from the Phase 1 cohort are anticipated from early 2027.

The first patient dosed in VISTA marks an important milestone in Infinitopes’ evolution from an academic spinout to a clinical-stage biotechnology company. Founded through support from multiple Cancer Research UK awards and the University of Oxford, Infinitopes has built integrated capabilities spanning antigen discovery, immunology, vaccinology, vector engineering, biomanufacturing and clinical development.

Further information about the study is available through the UK Clinical Trials Registry (IRAS 1008088).

(Press release, Infinitopes, JUL 23, 2026, View Source [SID1234669406])

On July 23, 2026 Agilent Technologies Inc. (NYSE: A) reported it has received European Union (EU) certification for PD-L1 IHC 22C3 pharmDx, Code SK006, as a companion diagnostic indicated to aid in identifying patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, whose tumors express PD-L1 and who may be eligible for treatment with KEYTRUDA (pembrolizumab), Merck’s (known as MSD outside the United States and Canada) anti-PD-1 therapy.

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PD-L1 IHC 22C3 pharmDx, Code SK006, enables pathologists to assess PD-L1 expression to identify patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma who may be eligible for treatment with pembrolizumab, in accordance with the approved product labelling, supporting informed treatment decisions in a disease where therapeutic options remain limited for many patients. This approval marks the eighth CE-marked companion diagnostic indication currently available for PD-L1 IHC 22C3 pharmDx, Code SK006 in the EU.

"Expanding access to precision oncology across regions is essential to improving patient outcomes," said Majken Nielsen, vice president and general manager of Agilent’s Clinical Diagnostics Division. "This EU approval builds on our commitment to deliver high-quality companion diagnostics and enables laboratories to support more informed treatment decisions for patients with epithelial ovarian, fallopian tube, or primary peritoneal carcinoma."

PD-L1 expression in epithelial ovarian, fallopian tube, or primary peritoneal carcinoma was evaluated using PD-L1 IHC 22C3 pharmDx, Code SK006, in the KEYNOTE-B96/ENGOT -ov65 clinical trial, supporting its use as an aid in identifying patients who may be eligible for treatment with pembrolizumab in the platinum-resistant setting.

In addition, PD-L1 IHC 22C3 pharmDx, Code SK006, is indicated in the EU to help physicians identify patients across several tumor types, including non-small cell lung cancer (NSCLC), esophageal cancer, cervical cancer, head and neck squamous cell carcinoma (HNSCC), triple-negative breast cancer (TNBC), gastric or gastroesophageal junction (GEJ) adenocarcinoma and urothelial carcinoma, who may be eligible for treatment with KEYTRUDA, in accordance with the approved product labelling.

PD-L1 IHC 22C3 pharmDx, Code SK006, was developed by Agilent in partnership with Merck (known as MSD outside of the United States and Canada) as a companion diagnostic for KEYTRUDA.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA

See the KEYTRUDA product label for specific clinical circumstances guiding therapy

(Press release, Agilent, JUL 23, 2026, View Source [SID1234669405])

On July 23, 2026 Thyora Therapeutics reported to have emerged from stealth as a biotechnology company leveraging next-generation covalent chemistry, with a mission to accelerate clinical translation and create therapies for high-unmet medical needs. Founded on breakthrough discoveries published today in Science by scientists at Moffitt Cancer Center, the company is advancing an integrated platform that combines novel covalent chemistry with AI-enabled chemoproteomics to unlock a new generation of precision therapeutics.Thyora was co-founded by Justin M. Lopchuk, Ph.D., Andrii Monastyrskyi, Ph.D., and Derek Duckett, Ph.D., inventors of the company’s foundational technologies, together with biotechnology executive T.J. Langer, who serves as Chief Executive Officer. Together, the founders established Thyora to translate pioneering science into transformative medicines by integrating world-class chemistry, pharmacology and drug discovery expertise.

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"When I first saw the science, I believed it represented one of those rare opportunities to build a company around discoveries that could fundamentally change an entire field," said T.J. Langer, Chief Executive Officer of Thyora Therapeutics. "The team has developed technologies with the potential to reshape how covalent medicines are discovered and developed and to reach disease targets long considered undruggable. We founded Thyora to bring those discoveries out of the laboratory and build a company capable of translating extraordinary science into transformative medicines for patients."

Coinciding with the company’s launch, researchers at Moffitt today published landmark findings in Science describing a novel strain-release bicyclobutane (BCB) chemistry that demonstrated exceptional cysteine selectivity while maintaining potent target engagement and improved drug-like properties in preclinical studies. The work establishes a promising new approach for designing safer, more selective covalent medicines and represents an important advance in the rapidly evolving field of targeted drug discovery.

To translate these discoveries into medicines, Thyora has entered into an exclusive agreement with Moffitt, securing worldwide rights to the foundational technologies underlying its platform, including:

The proprietary bicyclobutane (BCB) covalent warhead technology for the development of next-generation covalent modulators.
The Covalogic AI-enabled chemoproteomics discovery platform.
Related intellectual property developed by Thyora co-founders
Together, these complementary technologies create an integrated discovery platform capable of identifying, designing and optimizing highly selective covalent medicines against challenging disease targets.

"From the beginning, our goal was to create technologies that could expand what is possible in covalent drug discovery," said Derek Duckett, Ph.D., co-founder of Thyora Therapeutics and chair of the Drug Discovery Department at Moffitt. "Launching Thyora gives us the opportunity to build an enduring platform that continually generates innovative medicines based on these scientific advances."

Initially focused on oncology, Thyora is building a pipeline of differentiated precision covalent therapeutics while expanding the potential applications of its platform across additional serious diseases. By integrating proprietary chemistry, AI-enabled chemoproteomics and functional genomics, the company aims to create medicines with greater precision, improved selectivity and the potential to address important unmet medical needs.

(Press release, Thyora Therapeutics, JUL 23, 2026, View Source [SID1234669404])

On July 23, 2026 Summit Therapeutics Inc. (NASDAQ: SMMT) reported its financial results for the second quarter and six months ended June 30, 2026 and provided an update on clinical and operational progress.

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"The clinical momentum of ivonescimab continues to build, with two recent key data readouts that significantly bolster our development progress. At ASCO (Free ASCO Whitepaper), the landmark HARMONi-6 results established the first head-to-head Phase III study in any tumor type to demonstrate a meaningful overall survival advantage over anti-PD-1 inhibitors in combination with chemotherapy, representing an important milestone for cancer patients and for the broader immuno-oncology field," said Robert W. Duggan, Chairman and Co-Chief Executive Officer of Summit. "This was followed by updated overall survival data from the HARMONi trial, in which western patients replicated the survival benefit seen in Asian patients and further reinforces our confidence in the regional consistency of the efficacy results of ivonescimab."

"These new data continue to demonstrate the differentiated profile of ivonescimab," said Dr. Maky Zanganeh, President and Co-Chief Executive Officer of Summit. "In HARMONi-6, we saw an outcome that underscores the potential impact of our bispecific PD-1 / VEGF program. Equally important, the updated HARMONi overall survival analysis provided additional evidence of consistency of efficacy outcomes across patient populations. We also presented encouraging Phase II colorectal cancer data at ASCO (Free ASCO Whitepaper) that adds to the growing body of evidence supporting the potential of ivonescimab as a differentiated PD-1 / VEGF bispecific antibody across tumor types. We believe these results meaningfully strengthen the overall body of evidence supporting ivonescimab and provide important validation as we advance our global development program across multiple solid tumors."

Clinical & Operational Updates

Clinical and operational progress continues with ivonescimab (SMT112), an investigational, potentially first-in-class bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule:

Summit in-licensed ivonescimab from Akeso Inc. (Akeso, HKEX Code: 9926.HK) in January 2023. In total, over 4,000 patients have been treated with ivonescimab in clinical studies globally, and over 70,000 patients have been treated in the commercial setting with ivonescimab in China, as noted and updated by Akeso. Summit has exclusive rights to develop and commercialize ivonescimab in North America, South America, Europe, the Middle East, Africa, and Japan, while Akeso retains development and commercialization rights for remaining territories, including China.
Summit is developing ivonescimab in non-small cell lung cancer (NSCLC) and colorectal cancer (CRC), specifically conducting multiregional Phase III clinical trials in the following proposed indications:
HARMONi: Ivonescimab combined with chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a third-generation EGFR tyrosine kinase inhibitor (TKI);
HARMONi-3: Ivonescimab combined with chemotherapy in patients with first-line metastatic NSCLC, with two distinct cohorts to be analyzed separately for squamous tumors and non-squamous tumors;
HARMONi-7: Ivonescimab monotherapy in patients with first-line metastatic NSCLC whose tumors have high PD-L1 expression; and
HARMONi-GI3: Ivonescimab combined with chemotherapy in patients with first-line unresectable metastatic CRC.
HARMONi

In January 2026, the U.S. Food and Drug Administration (FDA) accepted for filing Summit’s Biologics License Application (BLA) seeking approval for ivonescimab in combination with chemotherapy in patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC who have received prior EGFR TKI therapy. The BLA was submitted based on the overall results of the global Phase III HARMONi trial. The FDA provided a Prescription Drug User Fee Act (PDUFA) goal action date of November 14, 2026.
In July 2026, Summit announced results of a new updated overall survival (OS) analysis from the HARMONi study, which showed a consistent OS trend amongst western and Asian patients as western patients were followed for additional time on study. These encouraging results provide further evidence of the geographic translatability of ivonescimab across the globe, including western patients from North America and Europe. In this new analysis, western patients increased their time on study, reaching a median follow-up of 23.2 months; Asian patients remained locked with a median follow-up time of 32.7 months. A hazard ratio of 0.76 was observed for the full ITT population; the same 0.76 hazard ratio was observed in both Asian and western patient subgroups, respectively, in this analysis. Ivonescimab continued to demonstrate an acceptable and manageable safety profile that was consistent with previous Phase III data of ivonescimab plus chemotherapy. No additional safety signals were observed. These results have been made available to the FDA, and more detailed data are intended to be presented at an upcoming medical meeting.
HARMONi-3

Enrollment in both the squamous and non-squamous NSCLC cohorts of the global HARMONi-3 study is now complete. The number of PFS events needed in the squamous cohort for the primary analysis is expected to be reached in the second half of 2026, and a planned early interim analysis for OS is expected to take place in conjunction with the primary PFS analysis. An interim analysis for overall survival independent of PFS is planned for the first half of 2027. For the non-squamous cohort, the number of events needed to conduct the PFS analysis is expected to be reached in the first half of 2027.
In a similar patient population to the squamous cohort of HARMONi-3, Akeso’s HARMONi-6 study evaluated ivonescimab plus platinum-based chemotherapy compared with tislelizumab, a PD-1 inhibitor, plus platinum-based chemotherapy in patients with locally advanced or metastatic squamous NSCLC, irrespective of PD-L1 expression. HARMONi-6 is a single-region, multi-center, Phase III study conducted in China and sponsored by Akeso with all relevant data exclusively generated and analyzed by Akeso.
Positive OS data for HARMONi-6 was presented in May 2026 as a part of the Plenary Session at the ASCO (Free ASCO Whitepaper) 2026 Annual Meeting; previously, positive PFS results for the HARMONi-6 trial were presented in October 2025 as part of the Presidential Symposium at the ESMO (Free ESMO Whitepaper) 2025 Annual Congress. In the recently presented HARMONi-6 analysis, ivonescimab in combination with chemotherapy demonstrated a statistically significant improvement in OS when compared to tislelizumab in combination with chemotherapy, with a hazard ratio of 0.66 (95% CI: 0.50, 0.87; p=0.0017). For both PFS and OS, a clinically meaningful benefit was demonstrated across clinical subgroups, including those with either PD-L1 negative or positive expression. The HARMONi-6 results represent the first regimen to achieve a statistically significant and clinically meaningful OS benefit over an anti-PD-(L)1 antibody combined with chemotherapy in a Phase III clinical trial in any tumor type including front-line NSCLC.
Additional Ivonescimab Development Updates

Summit’s global Phase III trials HARMONi-7 and HARMONi-GI3 continue to enroll. In addition to the multiregional studies conducted and sponsored by Summit, Akeso is enrolling several single-region Phase III studies exclusively in China in multiple indications, including biliary-tract cancer, triple-negative breast cancer, head and neck squamous cell carcinoma (HNSCC), small cell lung cancer, colorectal cancer, and pancreatic cancer.
Summit plans to continue further expansion of the global clinical development program for ivonescimab, including additional Phase III studies, in additional settings and tumor types. The company will continue to provide more details in the coming months with respect to additional Phase III studies evaluating ivonescimab beyond NSCLC, CRC, and HNSCC.
Summit’s clinical trial collaborations continue to progress as planned.
In July 2026, Summit announced a clinical collaboration with Arcus Biosciences, Inc. to evaluate ivonescimab in combination with Arcus’ novel HIF-2α inhibitor, casdatifan, in renal cell carcinoma. Data from the study under this collaboration agreement is expected to be generated by mid-2027.
In the second quarter of 2025, the company announced a clinical collaboration with Revolution Medicines, Inc. (RevMed) to evaluate ivonescimab in combination with three RAS(ON) inhibitors, including the multi-selective inhibitor daraxonrasib (RMC-6236), G12D-selective inhibitor zoldonrasib (RMC-9805), and G12C-selective inhibitor elironrasib (RMC-6291), in solid tumor settings with RAS mutations. As previously announced, the initial study under this collaboration, sponsored by RevMed, began enrolling patients in the first quarter of 2026.
In the first quarter of 2026, Summit announced a clinical collaboration with GORTEC, a European Head and Neck Oncology and Radiotherapy Group based in France, to evaluate ivonescimab monotherapy and ivonescimab in combination with ligufalimab, Akeso’s proprietary anti-CD47 monoclonal antibody, against monotherapy pembrolizumab in a randomized three-arm study. The Phase III study, GORTEC 2024-04 ILLUMINE (NCT07264075), is sponsored by GORTEC and is intended to be conducted in multiple countries in Europe and in China; Summit may consider the expansion of this study into the United States. ILLUMINE began enrolling patients in the second quarter of 2026.
In the first quarter of 2026, the company announced a clinical collaboration with GSK plc to evaluate ivonescimab in combination with GSK’s novel B7-H3 ADC, risvutatug rezetecan, in multiple solid tumors. The initial study under this collaboration agreement is expected to begin dosing patients later this quarter.
Clinical trial collaborations and investigator sponsored trials (ISTs) with leading academic organizations, including MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, and Dana Farber Cancer Institute, among others, continue to progress and expand evaluating ivonescimab in solid tumors. Summit is currently supporting more than 65 ISTs, of which 24 are actively enrolling.
In July 2026, Summit sold ridinilazole, an investigational Phase III precision antibiotic asset, to Biossil, Inc. Under the terms of the agreement, Summit will receive $500,000 upfront and up to $104.5 million in regulatory and commercial milestones, plus tiered royalties on net sales.
Financial Highlights

Cash and Cash Equivalents and Short-Term Investments

Aggregate cash and cash equivalents and short-term investments were $690.7 million and $713.4 million at June 30, 2026 and December 31, 2025, respectively.
During the second quarter of 2026, the company raised $230.8 million in gross proceeds through its ATM facility. Subsequent to June 2026, the company raised an additional $68.4 million in gross proceeds through its ATM facility.
GAAP and Non-GAAP Operating Expenses

GAAP operating expenses were $220.5 million for the second quarter of 2026, compared to $568.4 million for the same period of the prior year. The decrease in GAAP operating expenses was due to the decrease in stock-based compensation expense of $410.1 million primarily related to the modification to the company’s performance-based stock option awards during the second quarter of 2025.
Non-GAAP operating expenses were $151.8 million for the second quarter of 2026, compared to $89.6 million for the same period of the prior year. The increase in Non-GAAP operating expenses was primarily driven by the expansion of clinical studies and development costs related to ivonescimab.
GAAP and Non-GAAP Research and Development (R&D) Expenses

GAAP R&D expenses were $157.7 million for the second quarter of 2026, compared to $208.0 million for the same period of the prior year. The decrease was due to the decrease in stock-based compensation expense of $104.5 million primarily related to the modification to the company’s performance-based stock option awards during the second quarter of 2025.
Non-GAAP R&D expenses were $133.6 million for the second quarter of 2026, compared to $79.4 million for the same period of the prior year. The increase was primarily driven by the initiation of new clinical trials and expansion of current clinical trials from last year.
GAAP and Non-GAAP General and Administrative (G&A) Expenses

GAAP G&A expenses were $62.8 million for the second quarter of 2026, compared to $360.4 million for the same period of the prior year. The decrease was due to the decrease in stock-based compensation expense of $305.6 million primarily related to the modification to the company’s performance-based stock option awards during the second quarter of 2025.
Non-GAAP G&A expenses were $18.2 million for the second quarter of 2026, compared to $10.2 million for the same period of the prior year. The increase was primarily driven by the expansion of infrastructure and headcount to support the development of ivonescimab.
GAAP and Non-GAAP Net Loss

GAAP net loss in the second quarter of 2026 and 2025 was $215.7 million or $(0.28) per basic and diluted share, and $565.7 million or $(0.76) per basic and diluted share, respectively.
Non-GAAP net loss in the second quarter of 2026 and 2025 was $147.0 million or $(0.19) per basic and diluted share, and $86.9 million or $(0.12) per basic and diluted share, respectively.

(Press release, Summit Therapeutics, JUL 23, 2026, View Source [SID1234669403])

On July 23, 2026 Johnson & Johnson (NYSE: JNJ), a worldwide leader in multiple myeloma therapies, reported positive topline results from the three-arm investigational Phase 3 MonumenTAL-6 study evaluating TECVAYLI (teclistamab-cqyv) + TALVEY (talquetamab-tgvs), a BCMA and GPRC5D dual antigen targeting regimen, and TALVEY + pomalidomide in adult patients with relapsed or refractory multiple myeloma (RRMM) who received 1 to 4 prior lines of therapy, including an anti-CD38 antibody and lenalidomide.1 The study demonstrated statistically significant and clinically meaningful improvements in progression-free survival and overall survival for both investigational arms compared with investigator’s choice standard of care. TECVAYLI + TALVEY delivered the greatest benefit, reducing the risk of disease progression or death by 89% (HR, 0.11) and the risk of death by 62% (HR, 0.38).1 This represents the lowest hazard ratio seen across any Phase 3 study evaluating bispecific therapies in relapsed/refractory multiple myeloma.1

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Expert and company perspectives reinforce the potential of TECVAYLI + TALVEY

"These findings add to a growing body of Phase 3 evidence evaluating the survival outcomes associated with the early use of immunotherapy doublets in the treatment journey," said Ajay K. Nooka, M.D., M.P.H., F.A.C.P., Director, Myeloma Program, Department of Hematology and Medical Oncology, Emory University School of Medicine.* "TECVAYLI and TALVEY together generated deep and durable responses, demonstrating what’s possible by targeting BCMA and GPRC5D at the same time, and further reinforcing the potential of this off-the-shelf regimen to improve outcomes for patients across practice settings."

"At Johnson & Johnson, we have intentionally built a multiple myeloma portfolio that spans biological targets, mechanisms, modalities and lines of therapy, giving physicians the flexibility to use our therapies across a diverse patient population and throughout the patient journey," said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. "These findings further reinforce immunotherapy as a cornerstone of multiple myeloma care and strengthen the growing body of evidence supporting our leadership in this space. By continuing to expand treatment options across the disease continuum, we are moving closer to our ambition of one day curing this disease."

Topline results from the Phase 3 MonumenTAL-6 study

The MonumenTAL-6 study evaluated TECVAYLI in combination with TALVEY (Tec-Tal) or TALVEY with pomalidomide (Tal-P) compared to the investigator’s choice of either elotuzumab, pomalidomide, and dexamethasone (EPd) or pomalidomide, bortezomib, and dexamethasone (PVd) in participants with RRMM who have received at least one line of therapy, including an anti-CD38 antibody and lenalidomide.1 Both the Tec-Tal and Tal-P regimens met the study’s primary endpoint of PFS, demonstrating statistically significant and clinically meaningful improvements versus standard of care.1 Risk of progression or death was reduced in the Tec-Tal arm by 89% (hazard ratio [HR], 0.11; 95% confidence interval [CI], 0.08-0.16; p<0.0001) and 73% (HR, 0.27; 95% CI, 0.2-0.35) in the Tal-P arm.1 The overall safety profiles for the Tec-Tal and Tal-P treatment arms were consistent with the known safety profiles of each monotherapy.

Based on the strength of the data, the Independent Data Monitoring Committee (IDMC) recommended unblinding the study at the first interim analysis. The full results of the Phase 3 MonumenTAL-6 study will be presented at a future major medical meeting and shared with global health authorities.

About MonumenTAL-6
MonumenTAL-6 (NCT06208150) is a global, randomized, Phase 3 study evaluating TECVAYLI plus TALVEY and TALVEY plus pomalidomide versus investigator’s choice of elotuzumab, pomalidomide and dexamethasone (EPd) or pomalidomide, bortezomib and dexamethasone (PVd) in patients with relapsed or refractory multiple myeloma who have received one to four prior lines of therapy, including an anti-CD38 monoclonal antibody and lenalidomide. The primary endpoint is progression-free survival (PFS) as assessed by independent review committee. Key secondary endpoints include overall response rate (ORR), complete response or better (≥CR), MRD-negative complete response and overall survival (OS).

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.2 In multiple myeloma, these plasma cells proliferate and spread rapidly and replace normal cells in the bone marrow with tumors.3 Multiple myeloma is the second most common blood cancer worldwide.4 More than 180,000 new cases of multiple myeloma are diagnosed globally each year.5 People living with multiple myeloma have a 5-year survival rate of 59.8%.6 While some people diagnosed with multiple myeloma initially have no symptoms, most patients are diagnosed due to symptoms that can include bone fracture or pain, low red blood cell counts, tiredness, high calcium levels and kidney problems or infections.7,8 In recent years, overall survival has improved from years to decades, with effective treatment options now available across every stage and line of therapy.

(Press release, Johnson & Johnson, JUL 23, 2026, View Source;talvey-reduced-the-risk-of-disease-progression-or-death-by-89-and-the-risk-of-death-by-62-in-earlier-line-relapsedrefractory-multiple-myeloma-302833309.html [SID1234669402])