A nationally-published, award-winning journalist, Alex Biese joined the CURE team as an assistant managing editor in April 2023. Prior to that, Alex's work was published in outlets including the Chicago Sun-Times, MTV.com, USA TODAY and the Press of Atlantic City. Alex is a member of NLGJA: The Association of LGBTQ+ Journalists, and also performs at the Jersey Shore with the acoustic jam band Somewhat Relative.

Alex Biese

A phase 1 trial evaluating SENTI-202 demonstrated positive preliminary results in treating relapsed/refractory acute myeloid leukemia.

Positive preliminary data from a phase 1 clinical trial was recently announced evaluating SENTI-202 for the treatment of relapsed/refractory hematologic malignancies including acute myeloid leukemia (AML), according to a news release from Senti Biosciences.

SENTI-202 a first-in-class, off-the-shelf investigational cell therapy that uses engineered natural killer cells to target CD33 or FLT3 but not EMCN (CAR-NK), helping it more precisely attack certain blood cancers.

Data was presented on April 27 during a Clinical Trials Oral Minisymposium at the American Association for Cancer Research (AACR) Annual Meeting 2025.

“Senti was founded on engineering Logic Gated cell therapies with the enhanced ability to selectively kill cancer cells and protect healthy cells for cancer indications not addressable by existing drugs,” Dr. Timothy Lu, co-founder and CEO of Senti Biosciences, said in the news release. “Building upon these exciting results, we are continuing to prioritize development of our Logic Gating programs, including SENTI-202 and additional discovery efforts for solid tumors.”

Two of three patients in the preliminary recommended phase 2 dose (RP2D) cohort achieved a composite complete remission. Among seven patients evaluable for best overall response, five achieved an overall response, including four who reached composite complete remission — three with full hematologic recovery and one with partial hematologic recovery.

All four patients who achieved composite complete remission were measurable residual disease negative by local standard of care. All patients who achieved composite complete remission remain in remission, with the longest follow-up exceeding eight months, and three patients went on to receive a bone marrow transplant after treatment with SENTI-202.

“While preliminary, the results demonstrated by SENTI-202 to date continue to be encouraging,” said Dr. Stephen A. Strickland, Jr., director, Leukemia Research for Sarah Cannon Research Institute, and the lead author for the AACR abstract, in the news release.

He continued, “There remains a significant unmet medical need in AML for treatments that can overcome tumor heterogeneity and spare healthy cells. Early results are encouraging, not only for the deep durable complete remissions, but also for the excellent safety profile noted thus far. I look forward to seeing additional data and exploring the potential of SENTI-202 to provide a much-needed treatment option to people living with AML.”

Regarding safety, SENTI-202 was generally well tolerated, with side effects consistent with other investigational natural killer cell therapies and patients with AML receiving lymphodepleting chemotherapy. Among grade 3 (severe) or higher side effects seen in more than one patient, four patients each experienced febrile neutropenia and low platelet count, and two patients each had anemia and abdominal pain. All but one of these effects were considered unrelated to SENTI-202 or attributed to lymphodepleting chemotherapy. No grade 5 (death) side effects occurred.

Continuation of Trial and Presentation of Data

The phase 1 study of SENTI-202 is continuing to enroll patients to confirm the preliminary recommended phase 2 dose, followed by disease-specific expansion cohorts.

“Based on our clinical, correlative and preclinical data, we believe SENTI-202 has the potential to provide a safe and effective treatment option for AML,” Dr. Kanya Rajangam, president, head of R&D and chief medical officer of Senti Bio, said in the news release. “We remain focused on the successful execution of the study and look forward to further exploring SENTI-202’s potential.”

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Articles

SENTI-202, an investigational cell therapy using engineered natural killer cells, shows promising results in a phase 1 trial for relapsed/refractory hematologic malignancies, including AML. The therapy targets CD33 or FLT3 while sparing EMCN, enhancing precision in attacking blood cancers. Preliminary data reveals significant efficacy, with a high rate of composite complete remission and a favorable safety profile. The trial continues to enroll patients to confirm the recommended phase 2 dose. SENTI-202 holds potential as a safe, effective treatment for AML, addressing unmet medical needs.

SENTI-202 Shows Positive Preliminary Data in Acute Myeloid Leukemia

Breast MRI helps doctors detect disease in newly diagnosed and high-risk patients without replacing mammograms, according to an expert.

Breast MRI Offers Sensitive Imaging for High-Risk and Diagnosed Patients

Breast MRI is a powerful tool because of its sensitivity, helping doctors detect cancers that might not appear on a mammogram, according to Dr. Pouneh Razavi. She explained that breast MRI uses contrast to highlight areas where cancer may be growing faster than normal tissue, making it an important resource for certain patients.

Razavi, director of breast imaging for Johns Hopkins National Capital Region, shared that MRI is typically reserved for two groups: patients with a new diagnosis of breast cancer and those with a higher-than-average lifetime risk. For high-risk patients, MRI is offered once a year alongside yearly mammograms, typically spaced six months apart.

Razavi emphasized that MRI complements — but never replaces — mammography. By using both imaging tools and improving collaboration among care teams, she said, patients can receive a more accurate diagnosis and tailored treatment plans.

CURE: Can you explain when a breast MRI is typically recommended for patients with breast cancer?

 Breast MRI is indeed a powerful tool. It's powerful because it is very sensitive. With a breast MRI, what we do is we give contrast that is taken up via IV, either through the hand or through the arm for the patient, and then the contrast is picked up by all the breast tissue. What we do is we look at serial images, consecutive images following the administration of contrast to see if there's any lesion that might be taking up contrast at a different rate than the normal breast tissue.

The reason this is so helpful is because cancers generally recruit more blood vessels to themselves. So, they will pick up contrast at a faster rate than the regular breast tissue, the normal breast tissue. So, that's what we're looking at when we look at a breast MRI. So, it is very sensitive, and for that reason, it's a very powerful tool. We generally reserve it for two sets of populations.

No. 1 is patients with a new diagnosis of breast cancer, and No. 2 is patients who we know are at a higher lifetime risk of getting breast cancer than the average population. For those higher than lifetime-risk patients, we will offer a mammogram once a year. Mammogram is key. We never drop the mammogram. And we offer an MRI — usually at the six-month interval from the mammogram — once a year.

Transcript has been edited for clarity and conciseness.

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TAR-200 demonstrated a high disease-free survival and bladder preservation rates in BCG-unresponsive, high-risk non-muscle-invasive bladder cancer.

TAR-200, an intravesical chemotherapy releasing system, demonstrated responses in certain high-risk subgroups of patients with bladder cancer, according to data from Cohort 4 of the phase 2 SunRISe-1 study.

Specifically, TAR-200 demonstrated high disease-free survival (DFS) and bladder preservation rates in Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non-muscle-invasive bladder cancer with papillary-only disease (high-grade Ta or T1).

The DFS rate without the need for reinduction was more than 80%. Additionally, 94.2% of patients were able to preserve their bladder with this approach, according to the news release. Notably, these data were shared in a news release from Johnson & Johnson, as well as featured in a session entitled, "Paradigm-Shifting, Practice-Changing Clinical Trials in Urology" at the 2025 American Urological Association (AUA) Annual Meeting, in which the results were also shared.

Radical cystectomy: removal of the whole bladder; this can include removal of the prostate and seminal vesicles or the uterus, ovaries, fallopian tubes and part of the vagina.

Disease-free survival (DFS): the length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer.

Dysuria: discomfort, pain, or burning when urinating.

Pollakiuria: the need to urinate more often than normal.

“The majority of patients remained free of cancer recurrence during this critical early study period, highlighting the potential of TAR-200 as a highly effective treatment for these patients who may have limited options beyond bladder removal,” Dr. Félix Guerrero-Ramos, presenting author of the study, said. “As we continue monitoring patients through the 12-month mark and beyond, our focus remains on assessing TAR-200’s long-term efficacy in maintaining disease-free survival and improving outcomes for this high-risk patient population.”

The interim analysis of Cohort 4 of the SunRISe-1 study demonstrated 85.3% and 81.1% DFS rates at six and nine months, respectively, in patients with papillary-only disease treated with TAR-200. Notably, these results stayed consistent among patients with high-grade Ta and T1 disease at 85.7% and 84.7% at six months, as well as 82.1% and 79.4% at nine months, respectively. Additionally, patients showed early progression-free and overall survival rates of 95.6% and 98%, respectively, at nine months.

Although 12-month DFS data remain immature, these initial findings suggest that TAR-200 may provide durable disease control while reducing the need for invasive procedures, the news release emphasized. These results support the continued investigation of TAR-200 in the ongoing phase 3 SunRISe-5 study, which is comparing TAR-200 to chemotherapy in this patient population.

“BCG-unresponsive [patients] with high-risk non-muscle-invasive bladder currently face life-changing decisions during their treatment journeys. For many years, the standard of care for these patients has remained stagnant: surgical removal of the bladder,” said Dr. Henar Hevia, senior director and EMEA Therapeutic Area Lead of Oncology at Johnson & Johnson Innovative Medicine. “These results give hope for a new era of precision delivery of therapeutics in this patient population with a well-tolerated and effective bladder-sparing alternative, with the potential to drive better quality of life outcomes for patients.”

More Information on TAR-200 and Its Safety Profile

High-risk non-muscle-invasive bladder cancer is likely to recur or spread beyond the lining of the bladder, causing the disease to progress to muscle-invasive bladder cancer. This high-risk cancer is characterized by a high-grade, large tumor size, presence of multiple tumors and carcinoma in situ; it makes up 15% to 44% of patients with non-muscle-invasive bladder cancer.

Moreover, the current standard of care for this patient population is radical cystectomy and is recommended for patients whose disease fails to respond to BCG therapy, with over 90% cancer-specific survival if performed prior to muscle-invasive progression. However, because many patients with this disease are typically older, the patient population may be unwilling or unfit to undergo this procedure, meaning that recurrence of disease or progression can lead to morbidity and distress for these patients.

Based on these unmet needs, investigators are investigating TAR-200. TAR-200 is placed directly into the bladder by a healthcare professional during a short outpatient procedure that does not require anesthesia. Designed to stay in the bladder, it continuously releases treatment throughout the day without disrupting daily activities.

The ongoing phase 2b trial, SunRISe-1, is a randomized, open-label, multi-center study assessing the efficacy and safety of TAR-200 in patients with BCG-unresponsive high-risk non–muscle-invasive bladder cancer who are either ineligible for or have declined radical cystectomy. Cohort 4 specifically enrolls patients with papillary-only disease and treats them with TAR-200 monotherapy and the primary end point is DFS rate; key secondary end points include safety and tolerability.

This approach is designed to provide sustained and extended local release of gemcitabine into the bladder for patients. Notably, the safety and efficacy of this approach is being investigated in the phase 2 and phase 3 SunRISe-1, SunRISe-3 and SunRISe-5 for those with non-muscle-invasive bladder cancer. TAR-200 is also being evaluated for patients with muscle invasive bladder cancer in the SunRISe-4 trial.

Among the 52 participants who were enrolled and evaluated for this treatment, the safety profile of TAR-200 remained consistent with previous studies, with no new safety concerns identified. Most treatment-related side effects were low grade and resolved quickly, with a median duration of 3.7 weeks. Common treatment-related side effects included dysuria (40.4%), pollakiuria (30.8%) and urinary urgency (26.9%). Grade 3 or higher treatment-related side effects were reported in 13.5% of patients, with the most common one being bladder pain (3.8%). Serious treatment-related side effects occurred in three patients (5.8%), and four patients (7.7%) discontinued treatment due to treatment-related side effects. No treatment-related deaths were reported.

“Surgical removal of the bladder has long been the standard of care for patients suffering from BCG-unresponsive high-risk non-muscle-invasive bladder cancer with papillary-only disease, a life-altering procedure that drastically impacts a patient's quality of life,” Dr. Christopher Cutie, vice president and Disease Area Leader, Bladder Cancer, at Johnson & Johnson Innovative Medicine, concluded. “These results demonstrate that TAR-200 can be a meaningful alternative to surgery that is both effective and well-tolerated while preserving the bladder.”

TAR-200, an intravesical chemotherapy system, shows promise in treating BCG-unresponsive, high-risk non-muscle-invasive bladder cancer, particularly in papillary-only disease. The phase 2b SunRISe-1 study's Cohort 4 revealed high disease-free survival (DFS) and bladder preservation rates, with over 80% DFS and 94.2% bladder preservation. The treatment offers a potential alternative to radical cystectomy, especially for older patients. TAR-200's safety profile remains consistent, with mostly low-grade side effects. Ongoing trials aim to further assess its efficacy and safety in various bladder cancer stages.

TAR-200 Achieves High DFS and Bladder Preservation Rates in Bladder Cancer Subgroups

Zongertinib elicited meaningful results in previously treated patients with HER2-mutated, advanced non–small cell lung cancer: © Marco Desscouleurs - stock.adobe.com.

Among previously treated patients with HER2-mutated, advanced non-small cell lung cancer (NSCLC), treatment with zongertinib showed durable responses and clinically meaningful results, according to data published in a news release from the biopharmaceutical company Boehringer Ingelheim.

The findings were also featured in the official press program of the American Association for Cancer Research (AACR) Annual Meeting and published in 

New and updated data from the dose escalation, phase 1 Beamion LUNG-1 trial showed that, among 75 patients, the objective response rate was 71%. There was also a 7% complete response rate, 64% partial response and 96% disease control rate among previously treated patients, according to the news release.

Objective response rate: patients who responded partially or completely to treatment.

Complete response: the disappearance of cancer.

Partial response: a decrease in the extent of cancer in the body.

Disease control rate: patients who have achieved a complete response, partial response or stable disease.

Progression-free survival: the time a patient lives without their disease spreading or worsening.

Interstitial lung disease: inflammation and scarring of lung tissue.

Furthermore, zongertinib showed intracranial activity among 27 evaluable patients with brain metastases, with 41% achieving response and 81% experiencing disease control. The news release noted that the median duration of response of 14.1 months and progression-free survival of 12.4 months were presented for the first time at the 2025 AACR Annual Meeting.

"These data presented at AACR 2025 suggest that zongertinib may offer a new approach to treating patients with non-small cell lung cancer with activating HER2 mutations," said the trial's coordinating investigator, Dr. John Heymach. "Notably, more than 70% of patients experienced a tumor response, which is highly meaningful for those with this subtype of lung cancer. If approved by the FDA, zongertinib would be the first oral, targeted treatment option that addresses an unmet need for these patients."

Heymach is the chair of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center in Houston, in the news release

Zongertinib, as defined by the National Cancer Institute on its website, is an oral inhibitor of HER2 which prevents HER2-mediated signaling and may lead to cell death in HER2-expressing tumor cells. HER2, the National Cancer Institute explained, is overexpressed on a variety of tumor cell types and plays an important role in tumor cell proliferation and tumor blood vessel formation.

"Zongertinib has the potential to reset the benchmark for patients with HER2-mutant advanced non-small cell lung cancer, a patient population that has historically faced a poor prognosis,” Itziar Canamasas, global head of Oncology at Boehringer Ingelheim, said in the news release. “At Boehringer, we take cancer care personally; these updated data reaffirm our approach of addressing areas with high unmet need and letting our research guide us to where we can have the biggest impact for patients."

Based on the results of the Beamion LUNG-1 trial, the United States Food and Drug Administration (FDA) 

 to zongertinib for previously treated patients with HER2-mutant advanced NSCLC earlier this year.

Priority review designation, according to the FDA’s website, prioritizes the evaluation of certain drug applications. After approval, these drugs would significantly improve the safety or effectiveness of treatment, diagnosis or prevention of serious conditions compared with standard applications.

Initial study results among patients with advanced NSCLC with HER2 mutations who were previously treated with platinum-based chemotherapy and subsequent HER2-directed antibody-drug conjugates (31 patients) showed an objective response rate of 48% with a disease control rate of 97%. Additionally, an exploratory cohort of 20 patients that included HER2 mutations outside of the tyrosine kinase domain showed an objective response rate of 30% and a disease control rate of 65%, the news release reported.

The company reported that the data presented at AACR showed a manageable safety profile, with no drug-related deaths, cases of interstitial lung disease or cardiotoxicity reported, with the most commonly reported side effect being grade 1 (mild) diarrhea and a 17% incidence of grade 3 (severe) or higher drug-related side effects in patients with tyrosine kinase domain mutations.

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don’t forget to subscribe to CURE®’s newsletters here.

Zongertinib, an oral HER2 inhibitor, demonstrated promising results in treating HER2-mutated advanced non-small cell lung cancer (NSCLC) in the Beamion LUNG-1 trial. Among 75 patients, the objective response rate was 71%, with a 96% disease control rate. Intracranial activity was observed in patients with brain metastases, achieving a 41% response rate. The trial's findings led to the FDA granting priority review for zongertinib. The drug showed a manageable safety profile, with mild diarrhea as the most common side effect and no drug-related deaths reported.

Zongertinib elicited meaningful results in previously treated patients with HER2-mutated, advanced non–small cell lung cancer.

Alex Biese

SENTI-202 Shows Positive Preliminary Data in Acute Myeloid Leukemia

Breast MRI Offers Sensitive Imaging for High-Risk and Diagnosed Patients

TAR-200 Achieves High DFS and Bladder Preservation Rates in Bladder Cancer Subgroups

Zongertinib Elicits Responses in HER2-Mutant NSCLC

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