Kyle Doherty

TAR-200 led to an 82.4% complete response rate in BCG-unresponsive, high-risk non-muscle invasive bladder cancer with CIS, data from SunRISe-1 showed.

Among patients with Bacillus Calmette-Guérin (BCG)-unresponsive, high-risk non–muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary disease, treatment with TAR-200 — an intravesical chemotherapy releasing system — elicited high complete response rates, according to data from the phase 2b SunRISe-1 study.

These data were shared during the 2025 American Urological Association Annual Meeting, where investigators highlighted data from Cohort 2 of the trial which evaluated 85 patients within this population. Patients who received TAR-200 achieved an overall complete response rate of 82.4% and the 12-month complete response rate was 45.9%.

The Kaplan-Meier–estimated 12- and 24-month complete response rates were 52.4% and 44.7%, respectively. The median time to onset of complete response was 2.8 months and 95.7% of patients achieved a complete response within the first three months. The complete response rate was consistent across patient subgroups.

“The standard of care for [patients with] BCG-unresponsive, high-risk NMIBC is radical cystectomy,” Dr. Joseph Jacob, an associate professor of urology at Upstate University Hospital in Syracuse, New York, said during the presentation. “Radical cystectomy is a life changing operation with considerable morbidity and up to an 8% 90-day mortality rate. Unfortunately, many patients are unable or unwilling to undergo radical cystectomy. There are limited FDA-approved treatment options in patients with BCG-unresponsive, high-risk NMIBC.”

TAR-200 is a novel drug releasing system that employs an intravesical drug releasing application which provides sustained delivery of gemcitabine in the bladder. In December 2023, TAR-200 received breakthrough therapy designation from the FDA for the treatment of adult patients with BCG-unresponsive, high-risk NMIBC who are ineligible for or have declined radical cystectomy. Then in January 2025, a new drug application (NDA) was submitted to the FDA seeking the approval of the agent for the treatment of patients with BCG-unresponsive, high-risk NMIBC with CIS, regardless of the presence of papillary tumors.

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.

Complete response rate: the disappearance of all target lesions.

Carcinoma in situ (CIS): a group of abnormal cells.

Papillary disease: thin, finger-like cancerous tumors that usually start in the bladder lining and extend into the center of the bladder.

Additional findings from SunRISe-1 displayed that the median duration of response was 25.8 months. High-risk NMIBC recurrence was observed in 32.9% of responders and 5.7% experienced at least T2 disease progression. The 12-month cystectomy-free rate was 86.6%. The estimated 12- and 24-month duration of response probabilities were 56.2% and 51.8%, respectively. The 12-month duration of response rate was 52.9% and 47.1% of responses were ongoing at the data cutoff.

In terms of safety, most treatment-emergent side effects (TRAE) in cohort 2 were grade 1 (mild) or 2 (moderate) and resolved after a median of 3.1 weeks. Five patients experienced at least 1 serious treatment-related side effect and 3.5% of patients discontinued TAR-200 monotherapy due to treatment-related side effect. There were no treatment-related deaths.

Any-grade and grade 3 (severe) or higher treatment-related side effects occurred at rates of 83.5% and 12.9%, respectively. The most common any-grade TRAEs included pollakiuria (43.5%), dysuria (40%), and micturition urgency (24.7%). Grade 3 or higher treatment-related side effects consisted of urinary tract pain (4.7%), bladder pain (2.4%), and urinary tract infection (1.2%).

“Health-related quality of life remained high [during] TAR-200 treatment and TAR-200 monotherapy was well tolerated with rare serious TRAEs and treatment discontinuation,” Jacob said in conclusion. “TAR-200 is under review by the FDA following the submission of a NDA.”

Cohorts 1,2 and 3 of SunRISe-1 enrolled adult patients with histologically confirmed high-risk NMIBC with CIS with or without papillary disease with an ECOG performance status of 2 or less. Patients were also required to have persistent or recurrent disease within 12 months of completion of BCG therapy and be unresponsive to BCG therapy with no plans to undergo a radical cystectomy. Cohort 4 consisted of patients with papillary-only high-risk NMIBC without CIS.

In cohort 1, patients received TAR-200 in combination with cetrelimab and those in cohorts 2 and 3 received TAR-200 or cetrelimab monotherapy, respectively. Patients in cohort 4 also received TAR-200 monotherapy. TAR-200 was administered once every three weeks for the first 24 weeks then every 12 weeks through week 96 of treatment.

In cohorts 1, 2 and 3, the primary end point was overall complete response rate. Key secondary end points consisted of duration of response, overall survival, safety, tolerability and health-related quality of life. In cohort 4, the primary end point was disease-free survival.

At baseline, the median age in cohort 2 was 71 years. Most patients were male, White, former nicotine users, had an ECOG performance status of 0, and had CIS-only disease. The median number of prior doses of BCG was 12 and the median time from last receipt of BCG to CIS diagnosis was 3.2 months.

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Articles

TAR-200, an intravesical chemotherapy releasing system, demonstrated high complete response rates in patients with BCG-unresponsive, high-risk non–muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), according to the phase 2b SunRISe-1 study. The study reported an 82.4% overall complete response rate and a 45.9% 12-month complete response rate. The treatment was well-tolerated, with most side effects being mild or moderate. TAR-200 received FDA breakthrough therapy designation and is under review for approval for patients ineligible for or declining radical cystectomy.

TAR-200 showed high complete response rates in BCG-unresponsive, high-risk non-muscle invasive bladder cancer with CIS in the phase 2b SunRISe-1 study.

TAR-200 Shows High Response Rates in Bladder Cancer Subset

1.34 mg of Fotivda provided decreased tumor size and may be more tolerable than an 0.89-mg dose in RCC: © Axel Kock - stock.adobe.com

Among patients with renal cell carcinoma (RCC), the Food and Drug Administration (FDA)-approved starting dose of 1.34 milligrams (mg) of Fotivda (tivozanib) resulted in greater antitumor activity than a reduced dose of 0.89 mg, while incidence of hypertension were seen to be comparable.

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

Best overall response: The best response a patient has to treatment.

Overall survival: The time a patient lives, regardless of disease status.

This was according to results from an integrated efficacy and safety exposure response analysis that included the phase 3 TIVO-1, 

 studies presented at the 2025 ASCO Genitourinary Cancers Symposium.

“[There was a] strong exposure response relationship between cycle 2 [Fotivda] serum [exposures] and progression-free survival [PFS],” Dr. Bradley McGregor, lead study author, wrote in a poster presentation of the data. McGregor is director of Clinical Research for the Lank Center of Genitourinary Oncology, a senior physician as well as Marra Lochiatto Investigator at Dana-Farber Cancer Institute, and an assistant professor of medicine at Harvard Medical School, all in Boston.

When PFS was stratified by Fotivda cycle 2 exposures quartile, data showed that those who received a higher concentration of Fotivda had the longest median PFS of patients examined. Patients with an exposure ranging from 62 to 177 ng/mL had the longest median PFS at 9.7 months and the median PFS was as follows for those with an exposure ranging from 47.9 to 62.0 ng/mL (median PFS, 9.1 months), 38.4 to 47.9 ng/mL (median PFS, 7.3 months) and 13.9 to 38.4 ng/mL (median PFS, 5.6 months).

“A correlation between [Fotivda exposures] and change in tumor size from baseline was also observed,” McGregor wrote. “Patients in the TiNivo-2 combination therapy arm who received 0.89 mg [of Fotivda] are mostly clustered in the lowest [Fotivda exposure] quartile. As [exposure] quartiles of [Fotivda] increase, patients’ tumor size decreases, indicating [a] higher [Fotivda dose] results in an increased tumor response.”

The Fotivda exposure quartile correlations with changes in tumor size and best overall response (BOR) in the tumor size model revealed the following changes in median BOR for those with an exposure ranging from: 62 to 177 ng/mL (median BOR, –23.8), 47.9 to 62 ng/mL (median BOR, –17.3), 38.4 to 47.9 ng/mL (median BOR, –11.7) and 13.9 to 38.4 ng/mL (median BOR, –7.02). The respective groups included 183, 185, 173 and 176 patients.

In TiNivo-2, the lower dose of Fotivda was given in combination with Opdivo (nivolumab), and modeling data also showed that Opdivo did not affect the pharmacokinetics of Fotivda. Additionally, the incidence of any grade or grade 3 (severe) hypertension was not significantly different between patients who received the two doses of Fotivda.

Data Leading to This Exposure Response Analysis

 was approved by the FDA in March 2021 for the treatment of adults with relapsed or refractory advanced RCC following two or more prior systemic therapies based on data from TIVO-3. Data from the trial showed that the VEGFR TKI elicited a median overall survival (OS) of 16.4 months in patients (175 patients) versus 19.2 months in patients who received Nexavar (sorafenib, 175 patients). The median PFS was 5.6 months versus 3.9 months, respectively. The recommended dose of Fotivda per the prescribing information and FDA approval is 1.34 mg administered once daily with or without food for 21 consecutive days every 28 days until disease progression or unacceptable toxicity.

Fotivda was given at a lower dose of 0.89 mg for 21 days in a 28-day cycle in TiNivo-2 when it was combined with Opdivo, assuming a risk of hypertension. However, the lower-dose regimen did not improve outcomes when compared with Fotivda monotherapy given at the approved 1.34-mg monotherapy dose. A worsened trend for PFS was observed as patients treated with the doublet (171 patients) experienced a median PFS of 5.7 months versus 7.4 months with the monotherapy (172 patients).

“The results from the TiNivo-2 data set further confirmed that rechallenge with immunotherapy does not add benefit and optimal dosing of [Fotivda] provided the highest clinical benefit following progression on immunotherapy … [exposure response] models show that 1.34 mg [of Fotivda] provides greater antitumor activity than 0.89 mg. The hypertension incidence seems to be comparable, [and] these [exposure response] data suggest that a dose of 1.34 mg [of Fotivda] provides a greater decrease in tumor size and maybe more tolerable,” McGregor wrote in conclusion.

“Integrated efficacy and safety exposure response (ER) analysis of tivozanib (TIVO) for the treatment of renal cell cancer (RCC).” By Dr. Bradley McGregor, et al. 

The FDA-approved starting dose of Fotivda (tivozanib) at 1.34 mg demonstrates superior antitumor activity compared to a reduced dose of 0.89 mg in renal cell carcinoma (RCC) patients, with comparable hypertension incidence. Analysis from phase 3 studies shows a strong correlation between higher Fotivda exposure and improved progression-free survival (PFS) and tumor response. The combination of Fotivda with Opdivo did not enhance outcomes, confirming the optimal efficacy of the 1.34 mg dose. These findings suggest that the higher dose offers greater clinical benefits without increased hypertension risk.

Researchers showed that 1.34 mg of Fotivda provided decreased tumor size and may be more tolerable than an 0.89-mg dose among patients with renal cell carcinoma.

FDA-Approved Fotivda Dose More Effective Than Reduced Dose in RCC

Nubeqa plus ADT improved rPFS in mHSPC across all disease volumes, cutting the risk of radiological progression or death by 46%.

For patients with metastatic hormone-sensitive prostate cancer (mHSPC), efficacy outcomes were improved following treatment with Nubeqa (darolutamide) in combination with androgen deprivation therapy (ADT) compared with placebo plus ADT irrespective of disease volume, according to findings from the phase 3 ARANOTE trial.

Data from a subgroup analysis of ARANOTE presented during the 

 demonstrated that patients with high-volume disease who received Nubeqa (315 patients) achieved a median radiological progression-free survival (rPFS) of 30.2 months compared with 19.2 months among those who received placebo (157 patients). Patients with low-volume disease achieved a median rPFS of not reached (NR) in the investigational arm (131 patients) versus NR in the control arm (66 patients).

“The phase 3 ARASENS study demonstrated a greater than 30% reduction in the risk of death with the combination of [Nubeqa] plus ADT and docetaxel, which has become a standard of care for the treatment of patients with mHSPC,” Dr. Fred Saad said during a presentation of the data. “In ARANOTE, [Nubeqa] plus ADT significantly improved rPFS, reducing the risk of radiological progression or death by 46%. Volume of disease is a prognostic factor for patients with mHSPC and here we report a post-hoc analysis of ARANOTE to evaluate the efficacy and safety of [Nubeqa] by disease volume.”

Saad is the director of prostate cancer research at the Montreal Cancer Institute, a uro-oncologist in the Urology Department, and a full professor in the Department of Surgery at the Centre Hospitalier de l'Université de Montréal in Canada.

Radiological progression-free survival (rPFS): the time from treatment initiation to radiographic disease progression or death.

ECOG performance status of 0 to 2: a measure of a patient’s daily functioning, where 0 indicates full activity, and 2 indicates the ability to perform self-care but not work.

Visceral metastases: cancer that has spread to organs such as the liver, lungs or brain.

Gleason Score: a grading system that evaluates the aggressiveness of prostate cancer based on microscopic tumor appearance.

Overall survival (OS): the time from diagnosis or treatment start to death from any cause.

Time to initiation of subsequent anticancer therapy: the duration from treatment start to the beginning of the next line of cancer treatment.

Time to metastatic castration-resistant prostate cancer (mCRPC): the time from initial treatment to the development of resistance to hormone therapy with metastases.

Time to prostate-specific antigen (PSA) progression: the duration until a confirmed rise in PSA levels, indicating potential disease progression.

Rates of undetectable PSA: the proportion of patients achieving PSA levels below the detection threshold.

Time to pain progression: the time until a clinically significant worsening of pain related to cancer.

In November 2024, the FDA accepted a supplemental new drug application (sNDA) seeking the approval of Nubeqa plus ADT for the treatment of patients with mHSPC. The sNDA was supported by previous data from ARANOTE. Findings from ARANOTE presented during the 2024 ESMO Congress showed that regardless of disease volume patients who received Nubeqa plus ADT (446 patients) achieved a median rPFS of NR versus 25 months in the placebo arm (223 patients).

Diving Into the ARANOTE Trial and Baseline Characteristics

ARANOTE was a global, double-blind study that enrolled patients with mHSPC who had an ECOG performance status of 0 to 2. Patients were stratified based on the presence of visceral metastases (yes versus no) and receipt of prior local therapy (yes versus no). Eligible patients were randomly assigned 2:1 to receive Nubeqa at a dose of 600 milligrams twice daily or placebo, both in combination with ADT.

The primary end point was rPFS by central blinded review. Secondary end points included overall survival (OS), time to initiation of subsequent anticancer therapy, time to metastatic castration-resistant prostate cancer (mCRPC), time to prostate-specific antigen (PSA) progression, rates of undetectable PSA (less than 0.2 ng/mL), time to pain progression and safety.

In the post-hoc analysis that Saad presented, patients were evaluated based on disease volume per CHAARTED criteria. High-volume disease was defined as the presence of visceral metastases and/or at least four bone lesions with at least one lesion beyond the vertebral bodies and pelvis. Low-volume disease was defined as not meeting the high-volume criteria.

At baseline, the median age of the overall patient population was 70 years. Most patients had a Gleason score of at least 8 at initial diagnosis (68.3%) and de novo metastasis at initial diagnosis (72.5%). The study also included patients with visceral metastases (12%), those who had received prior local therapy (17.9%), and those with an ECOG performance status of 0 (49.8%). The median serum PSA level at baseline was 21.3 ng/mL.

Further Efficacy and Safety Data from the Analysis

Additional findings from the post-hoc analysis showed that patients in the high- and low-volume groups experienced a delayed time to mCRPC with Nubeqa plus ADT versus placebo plus ADT, which was consistent with the benefit observed in the overall population. Patients with high-volume disease in the investigational and control arms achieved a median time to mCRPC of NR versus 12.4 months, respectively. In the low-volume group, the median time to mCRPC was NR versus 19.8 months, respectively.

The addition of Nubeqa to ADT also led to a benefit compared with placebo plus ADT across all secondary end points examined. The greatest benefits were reported in time to initiation of subsequent systemic anticancer therapy in patients with low-volume disease, time to PSA progression in patients with low-volume disease and time to PSA progression in patients with high-volume disease.

“OS results were immature, but suggestive of a benefit with [Nubeqa] versus placebo,” Saad noted.

Evaluable patients with high-volume disease in the Nubeqa arm (304 patients) had undetectable PSA levels 24, 36 and 48 weeks after random assignment at rates of 44%, 48% and 50%, respectively; 55% of these patients achieved undetectable PSA at any time. Comparatively, patients in the placebo arm (148 patients) achieved undetectable PSA at rates of 11%, 13%, 14% and 16%, at the respective time points.

Patients with low-volume disease who received Nubeqa (121 patients) also experienced undetectable PSA levels at higher rates compared with those who received placebo (63 patients) at the 24- (72% versus 17%, respectively), 36- (78% versus 19%) and 48-week (79% versus 19%) time points. Patients experienced undetectable PSA at any time at rates of 83% versus 25%, respectively.

In terms of safety, patients with high-volume disease who received Nubeqa (314 patients) or placebo (156 patients) both experienced any-grade treatment-emergent side effects (TEAEs; 93% versus 91.7%, respectively), grade 3 (severe) or 4 (life-threatening) TEAEs (31.2% versus 31.2%), serious TEAEs (28.3% versus 25.6%) and TEAEs leading to study drug discontinuation (7.3% versus 8.3%). Patients with low-volume disease in the Nubeqa (131 patients) and placebo (65 patients) arms also experienced any-grade TEAEs (86.3% versus 86.2%), grade 3 or 4 TEAEs (29.8% versus 26.2%), serious TEAEs (12.2% versus 18.5%) and TEAEs leading to study drug discontinuation (3.1% versus 10.8%).

“Efficacy outcomes with [Nubeqa] plus ADT were improved versus placebo plus ADT regardless of disease volume,” Saad said in conclusion. “[Nubeqa] plus ADT was well tolerated in both high-volume and low-volume subgroups with low treatment discontinuation rates consistent with the overall population and reconfirming the established tolerability of darolutamide. Patients with low-volume mHSPC had marked treatment efficacy with minimal treatment burden.”

“Darolutamide plus ADT in patients with metastatic hormone-sensitive prostate cancer (mHSPC) by disease volume: subgroup analysis of the phase 3 ARANOTE trial.” By Dr. Fred Saad, et al. 

“Efficacy and safety of darolutamide plus androgen-deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) from the phase III ARANOTE trial.” By Dr. Fred Saad, et al. 

Nubeqa (darolutamide) combined with androgen deprivation therapy (ADT) significantly improved radiological progression-free survival (rPFS) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) compared to placebo plus ADT, regardless of disease volume. The ARANOTE trial demonstrated a 46% reduction in the risk of radiological progression or death. High-volume disease patients achieved a median rPFS of 30.2 months, while low-volume disease patients' rPFS was not reached. Nubeqa plus ADT was well tolerated, with low treatment discontinuation rates, confirming its established safety profile.

Nubeqa plus ADT improved rPFS in mHSPC regardless of disease volume, reducing the risk of radiological progression or death by 46%, per ARANOTE data.

Nubeqa Plus ADT Effective in mHSPC Regardless of Disease Volume

Monjuvi plus Revlimid and Rituxan demonstrated improved progression-free survival for patients with relapsed or refractory follicular lymphoma, as presented at the 2024 ASH annual meeting. 

For patients with relapsed or refractory follicular lymphoma, Monjuvi (tafasitamab-cxix) in addition to Revlimid (lenalidomide) and Rituxan (rituximab) led to a 57% reduction in the risk of disease progression or death versus the placebo plus Revlimid and Rituxan, according to findings from a phase 3 trial that were presented at the 

At a median follow-up of 14.1 months, the median investigator-assessed progression-free survival (PFS) was 22.4 months with the triplet (273 patients) versus 13.9 months with Revlimid and Rituxan alone (275 patients).

According to independent review committee (IRC) assessment, the median PFS was not yet reached with the triplet versus 16 months with the doublet.

“The inMIND phase 3 study met its primary end point of prolonging PFS in relapsed/refractory follicular lymphoma,” Dr. Laurie H. Sehn, lead study author of BC Cancer Centre for Lymphoid Cancer and The University of British Columbia, in Vancouver, Canada, said in a presentation of the data. “Benefit was observed in all prespecified subgroups, including patients with POD24 [progression of disease within 24 months of initial diagnosis], [those who were] refractory to prior anti-CD20 monoclonal antibodies, and [those] receiving multiple prior lines of therapy.”

Progression-free survival (PFS): time patients live without their cancer worsening or spreading.

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

Intravenous: treatment given through the vein.

Additional efficacy findings from the subgroup analysis also illustrated a PFS benefit favoring the investigational regimen regardless of POD24 status and refractoriness to anti-CD20 antibody therapy. In patients with POD24, the median PFS was 19.2 months with the triplet versus 11.3 months with the doublet. In patients without POD24, the median PFS was 23.6 months versus 16 months with the triplet and doublet, respectively.

In patients who were refractory to anti-CD20 antibody therapy the median PFS was 15 months in the investigational arm versus 8.6 months in the control arm. In patients who were not refractory to anti-CD20 antibody therapy the median PFS was 24 months versus 18.2 months with the investigational and control regimens, respectively.

With respect to response in the FDG-avid population the PET-CR rate was 49.4% in the investigational arm (251 patients) versus 39.8% in the control arm (254 patients). In the intention-to-treat population, the objective response rate (ORR) was 83.5% in the triplet arm versus 72.4% in the doublet arm.

Additional efficacy findings demonstrated that the median duration of response (DOR) was 21.2 months with the triplet versus 13.6 months with the doublet.

The median time to next treatment (TTNT) was not reached with the triplet versus 28.8 months with the doublet.

“The safety profile was manageable and consistent with expected toxicities with these agents,” Sehn said, turning to the regimen’s toxicity profile. 

Some of the most common any-grade treatment-emergent adverse effects (TEAEs, side effects) in the Monjuvi and placebo arms, respectively, included neutropenia (48.5%; 45.2%), diarrhea (37.6%; 28.3%), COVID-19 (31.4%; 23.5%), constipation (29.2%; 24.6%), rash (21.9%; 21.3%) and fatigue (21.2%; 15.8%). The most common grade 3 (severe) or 4 (life-threatening) TEAEs in the Monjuvi and placebo arms, respectively, included neutropenia (39.8%; 37.5%), pneumonia (8.4%; 5.1%), thrombocytopenia (6.2%; 7.4%) and decreased neutrophil (white blood cell) count (5.8%; 6.6%), among others. 

Sehn stated that Monjuvi and placebo dose interruptions or discontinuations because of TEAEs were similar between treatment arms, as were discontinuations for Revlimid.

Deaths occurred in 5.5% (15 patients) of patients in the investigational arm versus 8.5% (23 patients) of those in the placebo arm.

Most patients with follicular lymphoma will require more than one line of therapy, and although immunotherapy is a preferred regimen for patients with relapsed or refractory disease, the DOR of these agents remains limited.

The combination of Revlimid and Rituxan has been an FDA-approved regimen for patients with previously treated follicular lymphoma since 2018. The approval was based on data from the phase 3 AUGMENT trial, which showed an improvement in PFS versus Rituxan alone. Monjuvi is a CD19-directed monoclonal antibody that induces direct cytotoxic effects and improves NK cell and macrophage immune-mediated mechanisms.

A total of 548 patients were randomly assigned to treatment with Monjuvi (273 patients) or placebo (275 patients), and 51 (18.7%) and 42 (15.3%) remain on treatment, respectively. A total of 244 (89.4%) and 229 (83.3%) patients in the investigational and control arms, respectively, remain ongoing in the study. At the time of the analysis the median number of cycles received was 12 with Monjuvi versus 11 with placebo.

To be eligible for enrollment patients at least 18 years of age needed to have grade 1 to 3A follicular lymphoma or MZL and received at least one prior line of therapy, including an anti-CD20 monoclonal antibody. An ECOG performance status of 0 to 2 and no prior exposure to Revlimid plus Rituxan were also required.

Following confirmation of eligibility patients were randomly assigned to the experimental or control arm. In the experimental arm patients received 12 milligrams per kilogram (mg/kg) of intravenous (IV) Monjuvi every week for the first three cycles followed by every two weeks for cycles four through 12; plus 20 mg per day of oral Revlimid on days 1 to 21 for 12 cycles; and 375 mg per square meter of IV Rituxan once weekly for the first cycle and every four weeks for cycles two through five. In the control arm patients received IV placebo in the same schedule as Monjuvi, plus Revlimid and Rituxan via the same dosing schedule as the experimental arm.

“This study is the first to validate the approach of combining two antibodies for the treatment of patients with follicular lymphoma. [Monjuvi] plus [Revlimid] and [Rituxan] can be administered in community as well as academic settings and represents a potential new standard of care for patients with relapsed/refractory follicular lymphoma,” Sehn said in conclusion.

“Tafasitamab plus lenalidomide and rituximab for relapsed or refractory follicular lymphoma: results from a phase 3 study (inMIND).” By Dr. Laurie H. Sehn, 

Monjuvi (tafasitamab-cxix), combined with Revlimid (lenalidomide) and Rituxan (rituximab), significantly reduced the risk of disease progression or death in relapsed/refractory follicular lymphoma patients by 57% compared to placebo plus Revlimid and Rituxan. The phase 3 inMIND trial demonstrated prolonged progression-free survival (PFS) across all subgroups, including those with POD24 and refractory to anti-CD20 therapy. The investigational regimen showed a favorable safety profile, with manageable adverse effects. This combination may establish a new standard of care for relapsed/refractory follicular lymphoma.

Monjuvi plus Revlimid and Rituxan demonstrated improved progression-free survival for patients with relapsed or refractory follicular lymphoma.

Kyle Doherty

TAR-200 Shows High Response Rates in Bladder Cancer Subset

FDA-Approved Fotivda Dose More Effective Than Reduced Dose in RCC

Nubeqa Plus ADT Effective in mHSPC Regardless of Disease Volume

Monjuvi Combination May Improve Survival in Follicular Lymphoma

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