Courtney Flaherty 

Lutathera demonstrated antitumor activity in metastatic bronchopulmonary neuroendocrine tumors: © stock.adobe.com.

Lutathera showed antitumor activity in patients with metastatic bronchopulmonary neuroendocrine tumors, based on real-world data presented at the IASLC 2025 World Conference on Lung Cancer.

Among patients treated with Lutathera (23 patients), partial responses, stable disease and progressive disease occurred in 17%, 30% and 23% of patients, respectively.

“In clinical practice, the decision of when to utilize peptide receptor radionuclide therapy varies widely, found here most commonly as a third-line systemic agent,” Dr. Giuseppe Maiocco, a resident in the Division of Internal Medicine at the Mayo Clinic and coauthors wrote in a poster presentation.

What Are the Background and Design of this Real-World Study?

Lutathera is a peptide receptor radionuclide therapy and has emerged as a promising treatment in neuroendocrine tumors with selective targeting of somatostatin receptor–expressing cells.

In April 2024, the FDA approved Lutathera for the treatment of patients 12 years of age or older with somatostatin receptor–positive gastroenteropancreatic neuroendocrine tumors. This regulatory decision represented the first FDA approval of a radioactive drug or radiopharmaceutical for this patient population.

Of note, BP-NETs comprise approximately 20% to 30% of neuroendocrine tumors and the management of metastatic BP-NETs requires substantial tailoring. Accordingly, the objective of this real-world study was to evaluate the real-world use of Lutathera in patients with BP-NETs.

In the retrospective analysis, patients with metastatic BP-NETs were treated with peptide receptor radionuclide therapy at Mayo Clinic sites in Arizona, Florida and Minnesota between 2014 and 2025. Notably, tumor grade was defined by Ki-67 score and histology was defined per World Health Organization 2017 criteria.

Primary outcomes included response rates, progression-free survival and overall survival. Response rates were assessed by 3-month post-treatment interval restaging imaging and clinician document assessment. Progression-free survival was defined as therapy initiation to any disease progression, last follow-up or death; overall survival was defined as therapy initiation to last follow-up or death.

What Were the Baseline Patient Characteristics?

In the patient population, the median age was 66 years, 39% were female and 48% had a history of tobacco use. Metastatic sites included liver (78%), bone (61%), pancreas (9%) and contralateral lung (4%). Additionally, patients had grade 1 (26%), grade 2 (39%) or grade 3 (26%) disease per World Health Organization 2017 criteria. Carcinoid histology was either typical (43%) and atypical (57%). Furthermore, the majority of patients were nonfunctional (70%), had a Krenning scale score of 4 (57%) and an ECOG performance status of 0 (57%). The median number of therapy treatments was 4. Regarding treatment history, more than half of patients received 2 systemic treatments before therapy (52%). Preceding treatments included somatostatin analog (100%), chemotherapy (65%) with 43% of patients treated with single-line chemotherapy, Afinitor (43%) and a tyrosine kinase inhibitor (9%). Notably, 43% of patients did not receive systemic treatments following therapy.

What Other Efficacy and Safety Data Were Reported?

In all patients, the median progression-free survival was 10.8 months. Moreover, in patients with typical and atypical carcinoid histology, the median progression-free survival was 11.1 months and 8.4 months. Those with a Krenning score of 4 and a Krenning score of 3 or less had a median progression-free survival of 14.7 months and 7.3 months.

The median overall survival in all patients was 35.6 months. Patients with typical and atypical carcinoid histologies had a median overall survival of 35.5 months and 19.8 months. Patients with a Krenning score of 4 or a Krenning score of 3 or less had a median overall survival of 24.4 months and 16.5 months.

Regarding side effects, the most common treatment-related side effects included fatigue (35%), nausea (26%), abdominal pain (22%) and decreased appetite (13%).

“Lutathera was well tolerated, with no grade 3 or higher side effects,” Maiocco and coauthors concluded in the poster presentation.

Maiocco G, Hazim A, Halfdanarson T, et al. Real-world outcomes of patients with bronchopulmonary neuroendocrine tumors treated with Lutetium Lu-177 dotatate. Presented at: International Association for the Study of Lung Cancer 2025 World Conference on Lung Cancer; September 6-9, 2025; Barcelona, Spain. Abstract P3.13.32.

FDA approves lutetium Lu 177 dotatate for pediatric patients 12 years or older with GEP-NETS. FDA. April 23, 2024. Accessed September 9, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lutetium-lu-177-dotatate-pediatric-patients-12-years-and-older-gep-nets

Articles

Lutathera, a peptide receptor radionuclide therapy, demonstrated antitumor activity in patients with metastatic bronchopulmonary neuroendocrine tumors (BP-NETs) in a real-world study. The study, conducted at Mayo Clinic sites, assessed response rates, progression-free survival, and overall survival among patients treated with Lutathera. Results showed a median progression-free survival of 10.8 months and a median overall survival of 35.6 months. The treatment was well-tolerated, with common side effects including fatigue, nausea, and abdominal pain, and no grade 3 or higher side effects were reported.

Lutathera demonstrated antitumor activity in patients with metastatic bronchopulmonary neuroendocrine tumors.

Real-World Study Finds Benefit of Lutathera in Patients With Lung NETs 

Nubeqa plus hormone therapy improved progression-free survival and delayed PSA progression in metastatic prostate cancer with manageable side effects.

While the addition of Nubeqa (darolutamide) to androgen deprivation therapy proved clinically beneficial among patients with metastatic hormone-sensitive prostate cancer, the nurse’s role in educating patients on its effect and its safety is key, according to Brenda Martone, registered nurse and advanced practice provider.

At the 50th Annual Oncology Nursing Society Congress, safety and efficacy data from the phase 3 ARANOTE study were shared with oncology nurses so that they can better educate, and counsel patients being treated with this approach. The data, which were shared in a poster and previously presented, underscored that the Nubeqa combination (446 patients) resulted in a 46% reduction in the risk of radiological progression or death versus placebo and androgen deprivation therapy (223 patients). The median radiological progression-free survival in these respective arms was not reached versus 25 months, respectively. The 24-month radiological progression-free survival rate was 70.3% with Nubeqa versus 52.1% without it.

A positive trend in overall survival was also observed, with Nubeqa plus androgen deprivation therapy leading to a 19% reduction in the risk of death versus androgen deprivation therapy alone. Moreover, the Nubeqa combination led to a 60% reduction in risk of progression to metastatic castration-resistant prostate cancer; the median time to metastatic castration-resistant prostate cancer in these respective arms was not reached and 13.8 months.

A higher proportion of patients in the Nubeqa arm achieved undetectable prostate-specific antigen, defined as less than 0.2 nanograms per milliliter, versus those in the placebo arm, at 62.6% and 18.5%, respectively. The addition of Nubeqa to androgen deprivation therapy also delayed time to prostate-specific antigen progression, leading to a 69% reduction in the risk of prostate-specific antigen progression. The median time to prostate-specific antigen progression in the Nubeqa arm was not reached versus 16.8 months in the placebo arm.

Lastly, Nubeqa demonstrated clear benefits over placebo in terms of time to pain progression, an important patient-relevant end point. The median time to pain progression was not reached with Nubeqa versus 29.9 months without, translating to a 28% reduction in the risk of pain progression.

“When discussing treatment options with patients, it is important to consider efficacy, safety, and the impact of treatment on patients’ quality of life, and nurses play an important role in providing education to help patients manage disease symptoms and treatment side effects,” Martone, of Northwestern University, Feinberg School of Medicine in Chicago, and colleagues wrote in a poster of the data. “Together with the positive results of the phase 3 ARASENS study, the findings from ARANOTE provide the option to select treatment in metastatic hormone-sensitive prostate cancer with and without Taxotere to meet patients’ individual needs and preferences.”

The incidence of side effects was reported to be low and comparable between the treatment arms. Any side effects were experienced by 91% of those in the Nubeqa arm versus 90% of those in the placebo arm; grade 3 (severe) or 4 (life-threatening) side effects were experienced by 30.8% and 30.3% of patients, respectively. Moreover, serious side effects were reported in 23.6% of those who received Nubeqa plus androgen deprivation therapy versus 23.5% of those who only received androgen deprivation therapy.

Notably, a smaller proportion of patients in the Nubeqa arm experienced side effects that led to treatment discontinuation versus those in the placebo arm, at 6.1% versus 9%, respectively. Authors underscored that this is a “measure of drug tolerability.”

Moreover, the incidence of side effects linked with androgen receptor inhibitor therapy was low in both arms. Side effects included hypertension (Nubeqa, 9.4%; placebo, 9.5%), vasodilation or flushing (9.2%; 7.2%), diabetes or hyperglycemia (9%; 9.5%), cardiac arrhythmias (8.8%; 6.8%), fatigue (5.6%; 8.1%), rash (4.3%; 3.6%), bone fracture (4%; 2.3%), coronary artery disorders (3.6%; 1.4%), mental impairment (1.6%; 0.5%), falls (1.3%; 0.9%) and heart failure (0.9%; 0.9%).

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Nubeqa (darolutamide) combined with androgen deprivation therapy significantly benefits patients with metastatic hormone-sensitive prostate cancer, reducing risks of radiological progression, death, and progression to metastatic castration-resistant prostate cancer. The ARANOTE study highlighted a 46% reduction in radiological progression risk and a 19% reduction in death risk. Nurses play a crucial role in patient education regarding treatment efficacy, safety, and quality of life. Side effects were comparable between treatment arms, with a lower discontinuation rate in the Nubeqa group, indicating good drug tolerability.

Nubeqa plus hormone therapy improved outcomes in metastatic prostate cancer, reducing disease progression and showing a favorable safety profile.

Nubeqa Combo Improves Outcomes in Metastatic Prostate Cancer

Early and late responders with ESCC experienced comparable OS benefits with Tevimbra plus chemo.

Patients with locally advanced, unresectable or metastatic esophageal squamous cell carcinoma (ESCC) who responded to first-line Tevimbra (tislelizumab) plus chemotherapy showed improved overall survival (OS) with deeper responses and a longer time to maximum response, according to data from the phase 3 RATIONALE-306 study presented at the 

2025 ASCO Gastrointestinal Cancers Symposium.

As of November 24, 2023, 68.3% (207 patients) of patients in the intention-to-treat population who received Tevimbra plus chemotherapy achieved a response, with a median time to response of 6.1 weeks. Most responses (64.7%) were achieved within eight weeks of treatment; 22.2% of responses were achieved after eight weeks, up to and including 14 weeks; and 13% of responses were achieved after 14 weeks.

Overall survival: the time from diagnosis or treatment initiation when a patient with cancer is still alive.

Time to maximum response: time it takes for a patient’s tumor to reach the greatest degree of shrinkage or response to treatment.

Intention-to-treat population: a group of patients who were randomly assigned to receive a particular treatment, whether or not they actually received that treatment or adhered to it.

Depth of response rate: how much a tumor shrinks in response to therapy.

ECOG performance status of 0 or 1: a tool used by clinicians to assess a patient’s overall health and ability to perform daily activities. A status of 0 indicates that a patient is fully active and has no restrictions. With a status of 1, a patient is restricted in strenuous physical activity but is able to carry out light housework or sedentary activities.

Overall response rate: the percentage of patients whose cancer shrinks or disappears entirely after treatment.

PD-L1 tumor area positivity score of 10% or greater: at least 10% of the tumor area of covered by PD-L1-positive cells, which are proteins found on some cancer cells that helps cancer cells evade the immune system.

For patients in these three time-to-response groups, the median OS was 21.8 months, 23.1 months and 29 months, respectively. The median OS after first response in these respective groups were 21.3 months, 21.3 months and 23.2 months.

“In the [Tevimbra] plus chemotherapy arm, 64.7% of responders achieved a response within eight weeks, while still 35.2% of responders achieved response at later assessments,” lead study author Dr. Yi Li, of Fifth Medical Center, Chinese PLA General Hospital in Beijing, China, and colleagues wrote in a poster presentation of the data. “[However,] the [OS] benefits were comparable between early responders and late responders.”

The depth of response rate among responders to Tevimbra plus chemotherapy was 62.1%. Over half (50.2%) of responders achieved a depth of response above 50% up to and including 80%; a depth of response above 30% up to and including 50% was observed in 29.8% of responders; and a depth of response greater than 80% up to and including 100% was observed in 20% of responders. Among these three depth-of-response groups, the median OS was 23.7 months, 16.1 months and 34.5 months, respectively.

Among responders, the median time to maximum response was 19 weeks. Maximum response was achieved within 14 weeks, after 14 weeks up to and including 28 weeks, and after 28 weeks in 32.7%, 34.6% and 32.7% of responders, respectively. The median OS for patients in these respective time to maximum response categories was 14.3 months, 17.4 months and 39.9 months. The median OS after maximum response was 12.6 months, 14.3 months and 24.8 months, respectively.

RATIONALE-306 was a trial that enrolled patients at least 18 years of age with unresectable locally advanced or metastatic ESCC, no prior systemic treatment for advanced disease, an ECOG performance status of 0 or 1, and measurable or evaluable disease. Upon enrollment, patients were randomly assigned to receive Tevimbra or placebo intravenously once every three weeks alongside chemotherapy. Treatment continued until disease progression or unacceptable toxicity.

The study’s primary end point was OS in the intention-to-treat patient population. Key secondary end points included progression-free survival, overall response rate, duration of response, OS in patients with a PD-L1 tumor area positivity score of 10% or greater, and safety. Notably, tumor response was assessed every six weeks for the first 48 weeks and every nine weeks thereafter.

Disclosures: Dr Li has no relationships to disclose.

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Response characteristics of tislelizumab (TIS) plus chemotherapy (chemo) in first-line (1L) treatment of locally advanced or metastatic esophageal squamous cell carcinoma (ESCC): a post hoc analysis of RATIONALE-306. Dr Yi Li, et al. 

Patients with locally advanced, unresectable, or metastatic esophageal squamous cell carcinoma (ESCC) showed improved overall survival (OS) when treated with Tevimbra (tislelizumab) plus chemotherapy, as per the phase 3 RATIONALE-306 study. The study revealed that 68.3% of patients achieved a response, with a median time to response of 6.1 weeks. The depth of response and time to maximum response were significant factors influencing OS. The trial's primary endpoint was OS, with secondary endpoints including progression-free survival and overall response rate.

Early and late responders with esophageal squamous cell carcinoma experienced comparable OS benefits with Tevimbra plus chemo in the RATIONALE-306 trial.

Tevimbra Plus Chemotherapy May Improve Survival in First-Line ESCC

Opdivo and chemo showed long-term survival in advanced gastric, gastroesophageal junction or esophageal cancer.

Chinese patients with advanced gastric cancer, gastroesophageal junction (GEJ) cancer, or esophageal adenocarcinoma demonstrated a clinically meaningful, long-term improvement in overall survival (OS) compared with chemotherapy alone after first-line treatment with Opdivo (nivolumab) plus chemotherapy during the phase 3 CheckMate 649 trial.

 demonstrated that, at a minimum follow-up of 61.2 months for the Chinese population treated during the study, Opdivo plus chemotherapy (99 patients) generated a median OS of 14.3 months compared with 10.3 months for chemotherapy alone (109 patients) The 60-month OS rates were 20% and 7%, respectively.

Among patients with a PD-L1 combined positive score (CPS) of at least 5, those in the Opdivo group (75 patients) achieved a median OS of 15.5 months versus 9.6 months for patients in the chemotherapy group (81 patients). The respective 60-month OS rates were 24% and 8%.

Overall survival (OS): how long patients live after diagnosis.

Progression-free survival (PFS): how long patients live without disease progression.

Objective response rate (ORR): percentage of patients showing tumor shrinkage.

Complete response (CR): tumor is completely gone.

Partial response (PR): tumor shrinks by at least 30%.

Stable disease (SD): tumor neither shrinks nor grows.

Duration of response (DOR): how long a response lasts.

ECOG performance status: a measure of a patient's general health.

PD-L1 combined positive score (CPS): a measure of PD-L1 expression on tumor cells.

Immunologic etiology: immune system-related cause of disease.

The OS benefit with Opdivo plus chemotherapy was consistent across prespecified subgroups in the Chinese population.

In the overall population, the median progression-free survival (PFS) was 8.3 months for the Opdivo group versus 5.6 months for the chemotherapy alone group. In the population with a PD-L1 CPS of at least 5, the median PFS was 8.5 months and 4.3 months for Opdivo plus chemotherapy and chemotherapy alone, respectively.

“These extended follow-up results align with the overall CheckMate 649 trial population, reinforcing Opdivo plus chemotherapy as the standard first-line treatment for Chinese patients with advanced gastric cancer, GEJ cancer, [or] esophageal adenocarcinoma,” lead study author Dr. Lin Shen, and colleagues wrote in a poster presentation of the data.

Shen is vice president of Clinical Oncology at Beijing Cancer Hospital and Peking University, as well as deputy director at Beijing Institute for Cancer Research in China.

In April 2021, the FDA approved Opdivo combined with select types of chemotherapy for the frontline treatment of patients with advanced or metastatic gastric cancer, GEJ cancer, and esophageal adenocarcinoma, based on prior data from CheckMate 649.

Safety and Additional Efficacy Data for the Chinese Population

No new safety signals with Opdivo plus chemotherapy were reported with longer-term follow-up. Any-grade treatment-related side effects (TRAEs) occurred in 99% of patients in the Opdivo group versus 94% of patients in the control group. The rates of grade 3 (severe) or 4 (life-threatening) TRAEs were 66% and 50%, respectively. Serious any-grade TRAEs were reported in 26% of patients in the experimental group versus 13% of patients in the chemotherapy alone group. The respective rates of grade 3 or 4 serious TRAEs were 19% and 10%.

The most common grade 3 or 4 TRAEs reported in the Opdivo group included decreased neutrophil count (17%), decreased platelet count (7%), thrombocytopenia (7%), decreased white blood cell count (6%), anemia (6%) and neutropenia (6%).

In the chemotherapy alone group, the most frequent grade 3 or 4 TRAEs comprised decreased platelet count (11%), decreased neutrophil count (11%), neutropenia (8%) and vomiting (5%).

TRAEs led to treatment discontinuation in 51% of patients in the Opdivo group versus 26% of patients in the chemotherapy alone group. Four treatment-related deaths (4%) were reported in the experimental group versus 1 treatment-related death (1%) in the control group.

Notably, grade 3 or 4 TRAEs with potential immunologic etiology occurred in no more than 7% of Chinese patients in the Opdivo plus chemotherapy group across organ categories; no grade 5 (death) events occurred in either group.

In the overall population, the ORR was 66% in the Opdivo group versus 45% in the chemotherapy alone group. In the experimental group, the complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD) rates were 17%, 49%, 25% and 9%, respectively. These respective rates were 8%, 37%, 30% and 14% in the control group.

The median duration of response (DOR) in the overall population was 12.5 months for the Opdivo group versus 5.6 months for the chemotherapy alone group.

In the PD-L1 CPS of at least 5 population, the ORR was 68% in the Opdivo group versus 48% in the chemotherapy alone group. The respective CR, PR, SD and PD in the Opdivo group were 19%, 49%, 23% and 9%. These respective rates were 11%, 37%, 25% and 17% in the control group. The median DOR in this population was 12.5 months and 6.9 months for the experimental and control groups, respectively.

The OS, PFS and ORR benefits with the Opdivo regimen were consistent across different PD-L1 CPS subgroups.

Among all randomly assigned patients in the experimental group, patients who responded to Opdivo plus chemotherapy (49 patients) experienced a median OS of 21.5 months compared with nine months for those who had SD or PD (33 patients). In the chemotherapy group, responders (42 patients) achieved a median OS of 14.5 months versus 9.1 months for non-responders (34 patients).

In the population of patients with a PD-L1 CPS of at least 5, those who responded to Opdivo plus chemotherapy (40 patients) had a median OS of 23.3 months versus 11.5 months for those who did not respond to the experimental regimen (23 patients). In the chemotherapy group, the median OS was 13.1 months for responders (33 patients) versus 9.1 months for non-responders (22 patients).

The randomized, open-label, global phase 3 study enrolled patients with previously untreated, unresectable, advanced or metastatic gastric cancer, GEJ cancer and esophageal adenocarcinoma. Patients were not permitted to have HER2-positive disease, and an ECOG performance status of 0 to 1 was required.

Patients were randomly assigned in a 1:1:1 fashion. In the first experimental group, patients received Opdivo at 360 milligrams (mg) in combination with XELOX (oxaliplatin and capecitabine) once every three weeks; or Opdivo at 240 mg plus FOLFOX (oxaliplatin, leucovorin and fludarabine) once every two weeks. In the control group, patients received chemotherapy alone in the form of XELOX once every three weeks or FOLFOX once every two weeks. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent or end of study.

In the Opdivo group, 15% of patients received FOLFOX, and 85% were given XELOX. These rates were 13% and 87%, respectively, in the control group.

The study also included a second experimental group where patients received Opdivo at 1 mg per kilogram (mg/kg) plus Yervoy (ipilimumab) at 3 mg/kg once every three weeks for 4 cycles, followed by Opdivo alone at 240 mg once every two weeks.

Blinded independent central review–assessed PFS and OS in the population of patients with a PD-L1 CPS of at least 5 served as the trial’s dual primary end goal. Secondary end goals included OS and PFS in the overall population, the population of patients with a PD-L1 CPS of at least 1 and the population of patients with a PD-L1 CPS of at least 10; and overall response rate.

“First-line (1L) nivolumab (NIVO) plus chemotherapy (chemo) versus chemo in patients (pts) with advanced gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma (GC/GEJC/EAC): 5-year (y) follow-up of Chinese pts from CheckMate 649.” By Dr. Shen L et al. 

Opdivo (nivolumab) combined with chemotherapy significantly improved overall survival (OS) in Chinese patients with advanced gastric, gastroesophageal junction, or esophageal adenocarcinoma compared to chemotherapy alone, as shown in the CheckMate 649 trial. The median OS was 14.3 months for the Opdivo group versus 10.3 months for chemotherapy alone. The treatment was effective across various PD-L1 subgroups, with consistent progression-free survival (PFS) and overall response rate (ORR) benefits. Safety profiles were manageable, with no new safety signals, although treatment-related adverse events were more frequent in the Opdivo group.

Opdivo plus chemo showed long-term survival advantages in Chinese patients with advanced gastric, gastroesophageal junction or esophageal cancer.

Courtney Flaherty

Real-World Study Finds Benefit of Lutathera in Patients With Lung NETs

Nubeqa Combo Improves Outcomes in Metastatic Prostate Cancer

Tevimbra Plus Chemotherapy May Improve Survival in First-Line ESCC

Opdivo Regimen May Prolong Survival in Chinese Patients With Certain GI Cancers

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