On February 27, 2026 Certara, Inc. (Nasdaq: CERT), a global leader in model-informed drug development, reported that Company management will participate in the following investor conferences:

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TD Cowen 46th Annual Health Care Conference
Date and Time: Tuesday, March 3rd, 2026, at 3:10PM ET
Leerink Global Healthcare Conference
Date and Time: Monday, March 9th, 2026, at 8:00AM ET
Barclays 28th Annual Global Healthcare Conference
Date and Time: Tuesday, March 10th, 2026, at 1:00PM ET

Live webcasts for each of the conferences will be available on Certara’s investor relations website at View Source and will be available for replay for at least 90 days thereafter.

(Press release, Certara, FEB 27, 2026, View Source [SID1234663122])

On February 27, 2026 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and precision medicine, reported it will present new data in genitourinary malignancies at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU), taking place February 26-28, 2026.

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Across four oral presentations in muscle-invasive bladder cancer (MIBC), these data reinforce Signatera’s role in identifying patients who benefit from adjuvant immunotherapy, supporting response-adaptive bladder preservation strategies, and refining molecular residual disease (MRD) detection with plasma circulating tumor DNA (ctDNA) and urinary tumor DNA (utDNA).

Bladder Preservation: INDIBLADE and RETAIN

The INDIBLADE and RETAIN multicenter phase 2 trials demonstrate Signatera’s consistent performance in treatment response monitoring across diverse neoadjuvant regimens in MIBC, with 73-77% of patients demonstrating clearance of ctDNA following therapy and Signatera-negativity showing strong associations with positive outcomes, even with the bladder preserved.

INDIBLADE, the findings of which will be published today in Nature Medicine, investigated induction with combination immune checkpoint inhibitors (ICI) followed by chemoradiotherapy as a bladder-sparing strategy in stage II/III MIBC patients. The results show that Signatera status post-ICI was associated with bladder-intact event-free survival (BI-EFS). Specifically, Signatera-negativity at baseline and post-neoadjuvant therapy was linked to an 88.6% and 91% estimated two-year BI-EFS, respectively.

RETAIN evaluated a clinical response-adapted approach to identify patients for potential bladder-preservation following neoadjuvant therapy. The findings showed that post-treatment ctDNA clearance or negativity was associated with improved metastasis-free survival (MFS), and that Signatera-negative patients with no clinical or radiographic evidence of disease managed with active surveillance achieved MFS comparable to Signatera-negative patients undergoing cystectomy. In contrast, persistent Signatera-positivity was associated with poor outcomes.

Perioperative Care: NIAGARA

This phase 3 randomized perioperative study includes the first-ever presentation of utDNA data with clinical correlation. The combination of utDNA and ctDNA status post-neoadjuvant therapy and pre-cystectomy identified the group with the highest 24-month EFS. utDNA-positivity pre-cystectomy was more strongly associated with residual non-invasive disease vs ctDNA-positivity was more strongly associated with residual invasive disease. These data suggest that the combined assessment of utDNA and ctDNA can provide complementary risk stratification benchmarked against pathologic staging, enabling comprehensive identification of residual disease.

"As treatment options expand in perioperative and bladder preservation settings, we need tools that help us determine who truly requires additional therapy and who may safely avoid it," said Michiel van der Heijden, M.D., Ph.D., Netherlands Cancer Institute, principal investigator of INDIBLADE and presenting author of the NIAGARA study. "The data presented at ASCO (Free ASCO Whitepaper) GU demonstrate that MRD assessment with Signatera has strong correlations with outcomes and the potential to inform these critical treatment decisions."

"Following our milestone PMA submission to the FDA based on IMvigor011, these compelling data presentations reflect our commitment to transforming care across the spectrum of genitourinary malignancies," said Minetta Liu, M.D., chief medical officer of oncology and early cancer detection at Natera. "The new data suggests a particularly important opportunity for Signatera to optimize clinical decisions around bladder preservation, a major opening to improve patient quality of life."

The full list of presentations at ASCO (Free ASCO Whitepaper) GU includes:

February 27, 8:10 AM PT | Abstract #633 (Oral Presentation)
Presenter: Joaquim Bellmunt, M.D.
Circulating tumor (ct)DNA-guided adjuvant atezolizumab (atezo) in muscle-invasive bladder cancer (MIBC): Exploratory analysis of ctDNA dynamics in the IMvigor011 trial

February 27, 8:10 AM PT | Abstract #632 (Oral Presentation)
Presenter: Pooja Ghatalia, M.D.
Circulating tumor DNA (ctDNA) to guide response-adapted bladder preservation in muscle invasive bladder cancer (MIBC): Integrated analysis of the RETAIN trials

February 27, 11:30 AM PT | Abstract #797
Presenter: Can Aydogdu, M.D.
Integrating genomic profiling and circulating tumor DNA monitoring to optimize surveillance strategies in muscle-invasive bladder cancer

February 27, 11:30 AM PT | Abstract #831
Presenter: Can Aydogdu, M.D.
Association of ctDNA status with upstaging, pathologic outcomes, and genomic alterations in high-risk NMIBC

February 27, 2:30 PM PT | Abstract #637 (Oral Presentation)
Presenter: Jan-Jaap J. Mellema, M.D.
Induction ipilimumab plus nivolumab followed by consolidating chemoradiotherapy as bladder-sparing treatment in stage II/III urothelial carcinoma of the bladder: The phase 2 INDIBLADE trial

February 27, 4:00 PM PT | Abstract #636 (Oral Presentation)
Presenter: Michiel van der Heijden, M.D., Ph.D.
Urinary tumor DNA (utDNA) and circulating tumor DNA (ctDNA) in patients (pts) with muscle-invasive bladder cancer (MIBC) who received perioperative durvalumab (D) in NIAGARA

February 28, 7:00 AM PT | Abstract #532
Presenter: Shuchi Gulati, M.D., M.Sc.
Association of pre-operative circulating tumor DNA (ctDNA) status with clinicopathologic characteristics in patients (pts) with localized renal cell carcinoma (RCC)

February 28, 7:00 AM PT | Abstract #620
Presenter: Dalia Kaakour, M.D., MPH
Use of circulating tumor DNA (ctDNA) in the detection of residual disease and recurrence for patients with testicular cancer

February 27, 11:30 AM PT | Abstract #860
Presenter: Lingbin Meng, M.D., Ph.D.
Use of circulating tumor DNA (ctDNA) in the detection of residual disease and recurrence for patients with testicular cancer

February 27, 11:30 AM PT | Abstract #800
Presenter: Tanya Jindal, BS, BA
Predictive value of early circulating tumor DNA (ctDNA) response in advanced urothelial carcinoma (aUC) treated with enfortumab vedotin plus pembrolizumab (EVP).

February 28, 7:00 AM PT | Abstract #541
Presenter: David F. McDermott, M.D.
Circulating tumor DNA (ctDNA) analysis in participants (pts) with advanced clear cell renal cell carcinoma (ccRCC) treated with first-line pembrolizumab (pembro) monotherapy from the phase 2 KEYNOTE-427 study.

(Press release, Natera, FEB 27, 2026, View Source [SID1234663139])

On February 27, 2026 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported results from the final analysis of the pivotal Phase 3 KEYNOTE-B96 trial, also known as ENGOT-ov65, showing that KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with chemotherapy (paclitaxel) with or without bevacizumab significantly improved overall survival (OS), a key secondary endpoint, for patients with platinum-resistant recurrent ovarian cancer regardless of PD-L1 status versus paclitaxel with or without bevacizumab alone, the most active standard of care control arm for patients who are bevacizumab-eligible. These data will be presented for the first time today during a Best Oral Session at the European Society of Gynaecological Oncology (ESGO) 2026 Congress (abstract #526).

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As previously reported at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, KEYTRUDA plus paclitaxel with or without bevacizumab met its primary endpoint of progression-free survival (PFS) in the all comers population of patients with platinum-resistant recurrent ovarian cancer, as well as in patients whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1). The KEYTRUDA regimen also met its key secondary endpoint of OS in patients with platinum-resistant recurrent ovarian cancer whose tumors express PD-L1 (CPS ≥1).

At the final analysis, after a median follow-up of 32.7 months (range, 26.1-44.1), KEYTRUDA plus paclitaxel with or without bevacizumab demonstrated a statistically significant and clinically meaningful improvement in OS in all comers, reducing the risk of death by 18% (HR=0.82 [95% CI, 0.69-0.97]; p=0.0115) compared to paclitaxel with or without bevacizumab alone. For patients who received the KEYTRUDA regimen, median OS was 17.7 months versus 14.0 months for patients receiving the placebo regimen. The observed OS is among the longest reported in any clinical trial for platinum-resistant recurrent ovarian cancer, showing a clinically meaningful benefit of this regimen relative to the most active standard of care control arm, weekly paclitaxel with bevacizumab in bevacizumab-eligible patients.

"Patients with platinum-resistant ovarian cancer show reduced responses to traditional treatment regimens and may experience poor overall survival," said Dr. Nicoletta Colombo, director of the Gynecologic Oncology Program at the European Institute of Oncology in Milan, Italy. "These results build on prior data from the KEYNOTE-B96 trial and further define the clinical impact of this pembrolizumab-based regimen in appropriate patients with platinum-resistant recurrent ovarian cancer."

Additionally, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA in combination with paclitaxel with or without bevacizumab for the treatment of platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma in adults whose tumors express PD-L1 (CPS ≥1), and who have received one or two prior systemic treatment regimens.

In February, KEYTRUDA plus paclitaxel with or without bevacizumab was approved by the U.S. Food and Drug Administration (FDA) to treat adult patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test, and who have received one or two prior systemic treatment regimens based on previous data from the KEYNOTE-B96 trial.

"Results from the final analysis of KEYNOTE-B96, including overall survival data in the all comers population, demonstrate the continued clinical benefit of KEYTRUDA plus paclitaxel with or without bevacizumab for certain patients with platinum-resistant recurrent ovarian cancer," said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. "Taken together, the recent FDA approval and CHMP positive opinion underscore our commitment to the ovarian cancer community and our ongoing focus on delivering therapies that can help patients with unmet needs across women’s cancers."

Study design and additional data from KEYNOTE-B96/ENGOT-ov65
KEYNOTE-B96, also known as ENGOT-ov65, is a multicenter, randomized, double-blind placebo-controlled Phase 3 trial (ClinicalTrials.gov, NCT05116189) sponsored by Merck and conducted in collaboration with the European Network for Gynecologic Oncology Trial (ENGOT) groups investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy (paclitaxel) with or without bevacizumab compared to placebo plus paclitaxel with or without bevacizumab for the treatment of platinum-resistant recurrent ovarian cancer. The primary endpoint is PFS, as assessed by investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), and OS is a key secondary endpoint. The trial enrolled 643 patients with epithelial ovarian, fallopian tube or primary peritoneal carcinoma, regardless of PD-L1 tumor expression status, who received one or two prior lines of systemic therapy for ovarian carcinoma, including at least one line of platinum-based chemotherapy. Of the 643 enrolled patients, 72% of patients had tumors expressing PD-L1 (CPS ≥1). Patients were enrolled in KEYNOTE-B96 regardless of PD-L1 tumor expression status. Patients were randomized (1:1) to receive either KEYTRUDA plus paclitaxel with or without bevacizumab, or placebo plus paclitaxel with or without bevacizumab. KEYTRUDA (400 mg) or placebo were administered on Day 1 of each six-week treatment cycle and paclitaxel (80 mg/m2) was administered on Days 1, 8 and 15 of each three-week treatment cycle. The option to use bevacizumab was by investigator choice prior to randomization. Bevacizumab (10 mg/kg) was administered on Day 1 of a two-week treatment cycle.

At the final analysis, in the all comers population, KEYTRUDA plus paclitaxel with or without bevacizumab reduced the risk of disease progression or death by 27% (HR=0.73 [95% CI, 0.62-0.87]) compared to paclitaxel with or without bevacizumab alone. In patients with platinum-resistant recurrent ovarian cancer whose tumors express PD-L1 (CPS ≥1), the KEYTRUDA regimen reduced the risk of disease progression or death by 24% (HR=0.76 [95% CI, 0.62-0.93]) versus paclitaxel with or without bevacizumab alone. The KEYTRUDA regimen also continued to demonstrate a clinically meaningful improvement in OS, a key secondary endpoint of the study, in patients with platinum-resistant recurrent ovarian cancer whose tumors express PD-L1 (CPS ≥1), reducing the risk of death by 24% (HR=0.76 [95% CI, 0.62-0.93]) compared to paclitaxel with or without bevacizumab.

The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies; no new safety concerns were identified. Grade ≥3 treatment-related adverse events (TRAEs) occurred in 67.8% of patients receiving the KEYTRUDA regimen (n=320) versus 55.3% of patients receiving the placebo regimen (n=318). TRAEs led to death in 1.3% of patients receiving the KEYTRUDA regimen and 1.6% of patients receiving the placebo regimen.

Immune-mediated adverse events (AEs) and infusion reactions of any grade occurred in 39.4% of patients receiving the KEYTRUDA regimen and 18.9% of patients receiving the placebo regimen. The most common of these events (occurring in ≥10% of patients) was hypothyroidism (18.1%) in patients receiving the KEYTRUDA regimen. Immune-mediated AEs led to death in 0.6% of patients in the KEYTRUDA arm and in no patients in the placebo arm.

About platinum-resistant ovarian cancer
Ovarian cancer often begins in the fallopian tubes or the ovaries. As of 2022, it is the eighth most commonly diagnosed cancer and the eighth leading cause of cancer death among women worldwide. Globally, there were more than 324,000 patients diagnosed with ovarian cancer and almost 207,000 deaths from the disease in 2022. In many regions, its incidence has been increasing, with estimates projecting a 42% increase in new cases worldwide by 2040. Over 80% of patients diagnosed with ovarian cancer will experience disease progression following standard treatment with platinum-based chemotherapy regimens. Of these patients, approximately 25% will experience disease progression within six months of completing first-line platinum-based chemotherapy – defined as primary platinum-resistant ovarian cancer. Prognosis is particularly poor for these patients and approved treatment options are limited.

(Press release, Merck & Co, FEB 27, 2026, View Source [SID1234663124])

On February 27, 2026 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported results from the final analysis of the pivotal Phase 3 KEYNOTE-B96 trial, also known as ENGOT-ov65, showing that KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with chemotherapy (paclitaxel) with or without bevacizumab significantly improved overall survival (OS), a key secondary endpoint, for patients with platinum-resistant recurrent ovarian cancer regardless of PD-L1 status versus paclitaxel with or without bevacizumab alone, the most active standard of care control arm for patients who are bevacizumab-eligible. These data will be presented for the first time today during a Best Oral Session at the European Society of Gynaecological Oncology (ESGO) 2026 Congress (abstract #526).

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

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As previously reported at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2025, KEYTRUDA plus paclitaxel with or without bevacizumab met its primary endpoint of progression-free survival (PFS) in the all comers population of patients with platinum-resistant recurrent ovarian cancer, as well as in patients whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1). The KEYTRUDA regimen also met its key secondary endpoint of OS in patients with platinum-resistant recurrent ovarian cancer whose tumors express PD-L1 (CPS ≥1).

At the final analysis, after a median follow-up of 32.7 months (range, 26.1-44.1), KEYTRUDA plus paclitaxel with or without bevacizumab demonstrated a statistically significant and clinically meaningful improvement in OS in all comers, reducing the risk of death by 18% (HR=0.82 [95% CI, 0.69-0.97]; p=0.0115) compared to paclitaxel with or without bevacizumab alone. For patients who received the KEYTRUDA regimen, median OS was 17.7 months versus 14.0 months for patients receiving the placebo regimen. The observed OS is among the longest reported in any clinical trial for platinum-resistant recurrent ovarian cancer, showing a clinically meaningful benefit of this regimen relative to the most active standard of care control arm, weekly paclitaxel with bevacizumab in bevacizumab-eligible patients.

"Patients with platinum-resistant ovarian cancer show reduced responses to traditional treatment regimens and may experience poor overall survival," said Dr. Nicoletta Colombo, director of the Gynecologic Oncology Program at the European Institute of Oncology in Milan, Italy. "These results build on prior data from the KEYNOTE-B96 trial and further define the clinical impact of this pembrolizumab-based regimen in appropriate patients with platinum-resistant recurrent ovarian cancer."

Additionally, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA in combination with paclitaxel with or without bevacizumab for the treatment of platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma in adults whose tumors express PD-L1 (CPS ≥1), and who have received one or two prior systemic treatment regimens.

In February, KEYTRUDA plus paclitaxel with or without bevacizumab was approved by the U.S. Food and Drug Administration (FDA) to treat adult patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma whose tumors express PD-L1 (CPS ≥1) as determined by an FDA-authorized test, and who have received one or two prior systemic treatment regimens based on previous data from the KEYNOTE-B96 trial.

"Results from the final analysis of KEYNOTE-B96, including overall survival data in the all comers population, demonstrate the continued clinical benefit of KEYTRUDA plus paclitaxel with or without bevacizumab for certain patients with platinum-resistant recurrent ovarian cancer," said Dr. Gursel Aktan, vice president, global clinical development, Merck Research Laboratories. "Taken together, the recent FDA approval and CHMP positive opinion underscore our commitment to the ovarian cancer community and our ongoing focus on delivering therapies that can help patients with unmet needs across women’s cancers."

Study design and additional data from KEYNOTE-B96/ENGOT-ov65
KEYNOTE-B96, also known as ENGOT-ov65, is a multicenter, randomized, double-blind placebo-controlled Phase 3 trial (ClinicalTrials.gov, NCT05116189) sponsored by Merck and conducted in collaboration with the European Network for Gynecologic Oncology Trial (ENGOT) groups investigating KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy (paclitaxel) with or without bevacizumab compared to placebo plus paclitaxel with or without bevacizumab for the treatment of platinum-resistant recurrent ovarian cancer. The primary endpoint is PFS, as assessed by investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), and OS is a key secondary endpoint. The trial enrolled 643 patients with epithelial ovarian, fallopian tube or primary peritoneal carcinoma, regardless of PD-L1 tumor expression status, who received one or two prior lines of systemic therapy for ovarian carcinoma, including at least one line of platinum-based chemotherapy. Of the 643 enrolled patients, 72% of patients had tumors expressing PD-L1 (CPS ≥1). Patients were enrolled in KEYNOTE-B96 regardless of PD-L1 tumor expression status. Patients were randomized (1:1) to receive either KEYTRUDA plus paclitaxel with or without bevacizumab, or placebo plus paclitaxel with or without bevacizumab. KEYTRUDA (400 mg) or placebo were administered on Day 1 of each six-week treatment cycle and paclitaxel (80 mg/m2) was administered on Days 1, 8 and 15 of each three-week treatment cycle. The option to use bevacizumab was by investigator choice prior to randomization. Bevacizumab (10 mg/kg) was administered on Day 1 of a two-week treatment cycle.

At the final analysis, in the all comers population, KEYTRUDA plus paclitaxel with or without bevacizumab reduced the risk of disease progression or death by 27% (HR=0.73 [95% CI, 0.62-0.87]) compared to paclitaxel with or without bevacizumab alone. In patients with platinum-resistant recurrent ovarian cancer whose tumors express PD-L1 (CPS ≥1), the KEYTRUDA regimen reduced the risk of disease progression or death by 24% (HR=0.76 [95% CI, 0.62-0.93]) versus paclitaxel with or without bevacizumab alone. The KEYTRUDA regimen also continued to demonstrate a clinically meaningful improvement in OS, a key secondary endpoint of the study, in patients with platinum-resistant recurrent ovarian cancer whose tumors express PD-L1 (CPS ≥1), reducing the risk of death by 24% (HR=0.76 [95% CI, 0.62-0.93]) compared to paclitaxel with or without bevacizumab.

The safety profile of KEYTRUDA in this trial was consistent with that observed in previously reported studies; no new safety concerns were identified. Grade ≥3 treatment-related adverse events (TRAEs) occurred in 67.8% of patients receiving the KEYTRUDA regimen (n=320) versus 55.3% of patients receiving the placebo regimen (n=318). TRAEs led to death in 1.3% of patients receiving the KEYTRUDA regimen and 1.6% of patients receiving the placebo regimen.

Immune-mediated adverse events (AEs) and infusion reactions of any grade occurred in 39.4% of patients receiving the KEYTRUDA regimen and 18.9% of patients receiving the placebo regimen. The most common of these events (occurring in ≥10% of patients) was hypothyroidism (18.1%) in patients receiving the KEYTRUDA regimen. Immune-mediated AEs led to death in 0.6% of patients in the KEYTRUDA arm and in no patients in the placebo arm.

About platinum-resistant ovarian cancer
Ovarian cancer often begins in the fallopian tubes or the ovaries. As of 2022, it is the eighth most commonly diagnosed cancer and the eighth leading cause of cancer death among women worldwide. Globally, there were more than 324,000 patients diagnosed with ovarian cancer and almost 207,000 deaths from the disease in 2022. In many regions, its incidence has been increasing, with estimates projecting a 42% increase in new cases worldwide by 2040. Over 80% of patients diagnosed with ovarian cancer will experience disease progression following standard treatment with platinum-based chemotherapy regimens. Of these patients, approximately 25% will experience disease progression within six months of completing first-line platinum-based chemotherapy – defined as primary platinum-resistant ovarian cancer. Prognosis is particularly poor for these patients and approved treatment options are limited.

(Press release, Merck & Co, FEB 27, 2026, View Source [SID1234663125])

On February 27, 2026 MonTa Biosciences, a Copenhagen-based clinical-stage biotech company developing next-generation innate immune modulators for cancer therapy, reported the expansion of its clinical program with MBS8, a systemically administered second-generation TLR7 agonist, in checkpoint-resistant cutaneous melanoma and metastatic uveal melanoma.

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Unlike first-generation systemic TLR7 approaches that were limited by toxicity, MBS8 utilizes a proprietary lipid micelle formulation designed to enable controlled innate immune activation while maintaining systemic tolerability. Phase I evaluation established a favorable safety profile, encouraging tumor effects and a recommended dose for further development

The multi-center expansion study will enroll patients in Denmark and Spain. MBS8 will be evaluated in combination with pembrolizumab (Keytruda) in patients with acquired resistance to PD-1 therapy, and as monotherapy in uveal melanoma patients previously treated with T-cell engagers.

CEO Statement
"We are very encouraged by the MBS8 phase I data generated and believe systemic TLR7 agonism is entering a new era of clinical validation and investment momentum," said Simon Skjøde Jensen, CEO of MonTa Biosciences. "With Phase I safety established, we are advancing MBS8, which we believe has Best-in-class potential, into defined resistant melanoma populations where innate immune activation may restore responsiveness to immunotherapy. As capital and clinical momentum accelerate in the TLR7 field, we see a clear opportunity to differentiate through safety, formulation, and rational combination strategies."

Addressing Checkpoint Resistance
Although immune checkpoint inhibitors have transformed melanoma treatment, up to 40–50% of responding patients ultimately relapse—representing approximately 10-12,000 patients annually across the US and EU—with no broadly effective therapy specifically targeting acquired resistance.

Orphan Opportunity in Metastatic Uveal Melanoma
Metastatic uveal melanoma remains a major unmet need, with approximately 4,000 new cases annually in the US and Europe. The indication qualifies for orphan designation, offering potential regulatory incentives and accelerated development pathways. Checkpoint inhibitors show response rates below 10%, and while a T-cell engager is approved for a subset of patients, durable responses remain limited.

TLR7 Agonism Gains Clinical Validation and Reduces Development Risk
Systemic TLR7 agonism is rapidly re-emerging as a validated immuno-oncology strategy, supported by substantial capital deployment and advancing clinical data. Eikon Therapeutics has raised more than USD 1 billion to advance its TLR7 agonist EIK1001 into Phase II/III development and completed its NASDAQ listing in February 2026. Interim Phase II data in NSCLC demonstrated improved progression-free survival when EIK1001 was combined with chemotherapy and pembrolizumab, reinforcing the clinical relevance of systemic innate immune activation.

In parallel, a landmark Nature publication (Grippin et al., 2025) showed that NSCLC and melanoma patients receiving an mRNA COVID-19 vaccine—known to partly activate TLR7 signaling—within 100 days of initiating checkpoint therapy experienced significantly improved survival, including nearly doubled 36-month overall survival in NSCLC.
Collectively, these developments materially reduce development and clinical risk for MBS8 and underscore its potential to enhance checkpoint efficacy.

MonTa’s MBS8 is, alongside EIK1001, among the most advanced systemically administered TLR7 agonists with completed Phase I safety data, positioning the company at the forefront of this revalidated therapeutic class.

(Press release, MonTa Biosciences, FEB 27, 2026, View Source [SID1234663126])