Relevance: primary · Type: event
Confidence100%
In the TAISHAN-302 study, patients treated with tambotatug pelitecan had a median overall survival of 13.3 months compared to 9.4 months for those treated with topotecan.
Source: TAISHAN-302
Relevance: primary · Type: event
Confidence100%
Treatment with tambotatug pelitecan reduced the risk of death by 54% compared to topotecan (HR 0.46, 95% CI 0.35-0.62, P<0.0001) in the TAISHAN-302 study.
Source: TAISHAN-302
Relevance: supporting · Type: background
Confidence100%
The median follow-up was 9.2 months in the TAISHAN-302 study.
Source: TAISHAN-302
Relevance: supporting · Type: action
Confidence100%
Li Zhang reported the TAISHAN-302 study results at the World Conference on Lung Cancer in Seoul, South Korea.
Source: World Conference on Lung Cancer proceedings
Relevance: supporting · Type: action
Confidence100%
The TAISHAN-302 trial results were published in the New England Journal of Medicine.
Source: New England Journal of Medicine
Relevance: primary · Type: event
Confidence100%
In the ARTEMIS-008 study, patients treated with risvutatug rezetecan had a median overall survival of 18.5 months compared to 10.3 months for those treated with topotecan.
Source: ARTEMIS-008 study results
Relevance: primary · Type: event
Confidence100%
Treatment with risvutatug rezetecan reduced the risk of death by 54% compared to topotecan (HR 0.46, 95% CI 0.35-0.62, P<0.0001) in the ARTEMIS-008 study.
Source: ARTEMIS-008 study results
Relevance: supporting · Type: background
Confidence100%
The median follow-up was 12.2 months in the ARTEMIS-008 study.
Source: ARTEMIS-008 study results
Relevance: supporting · Type: action
Confidence100%
Jie Wang reported the ARTEMIS-008 study results at the World Conference on Lung Cancer.
Source: World Conference on Lung Cancer proceedings
Relevance: primary · Type: event
Confidence100%
In the TAISHAN-302 study, median progression-free survival was 7.4 months with tambotatug pelitecan versus 2.8 months with topotecan (HR 0.29, 95% CI 0.23-0.37, P<0.001).
Source: TAISHAN-302
Relevance: primary · Type: event
Confidence100%
In the ARTEMIS-008 study, median progression-free survival was 7.2 months with risvutatug rezetecan versus 3.0 months with topotecan (HR 0.33, 95% CI 0.25-0.42).
Source: ARTEMIS-008 study results
Relevance: supporting · Type: event
Confidence100%
The objective response rate was 59.1% with tambotatug pelitecan versus 9.7% with topotecan in the TAISHAN-302 study.
Source: TAISHAN-302
Relevance: supporting · Type: event
Confidence100%
The objective response rate was 58.3% with risvutatug rezetecan versus 12.6% with topotecan in the ARTEMIS-008 study.
Source: ARTEMIS-008 study results
Anne Chiang, MD, PhD
Relevance: supporting · Type: quote
Confidence100%
"Both Tam-Peli and Ris-Rez will be great options for our patients."
Source: medpagetoday.com
Anne Chiang, MD, PhD
Relevance: supporting · Type: quote
Confidence100%
"In my opinion, there is a new standard emerging."
Source: medpagetoday.com
Anne Chiang, MD, PhD
Relevance: supporting · Type: quote
Confidence100%
Anne Chiang predicted that antibody-drug conjugates will become the new second-line treatment for relapsed small-cell lung cancer within the next 2 to 5 years.
Source: medpagetoday.com
Relevance: supporting · Type: background
Confidence100%
The TAISHAN-302 phase III open-label study randomized 451 patients to tambotatug pelitecan and topotecan.
Source: TAISHAN-302 study protocol
Relevance: supporting · Type: background
Confidence100%
Patients receiving tambotatug pelitecan in the TAISHAN-302 study were treated with 2.0 mg/kg IV on day 1 of each 3-week cycle, with a maximum dose of 200 mg.
Source: TAISHAN-302 study protocol
Relevance: supporting · Type: background
Confidence100%
The median patient age was 62 in the TAISHAN-302 study.
Source: TAISHAN-302
Relevance: supporting · Type: background
Confidence100%
Patients who had never smoked accounted for 28.0% in the tambotatug pelitecan group and 30.1% in the topotecan group in the TAISHAN-302 study.
Source: TAISHAN-302
Relevance: supporting · Type: background
Confidence100%
Across the two groups in the TAISHAN-302 study, 96.2% had systemic disease and 34.4% had a history or presence of brain metastases at baseline.
Source: TAISHAN-302
Relevance: supporting · Type: background
Confidence100%
A total of 393 patients (87.1%) in the TAISHAN-302 study had received previous anti-PD-L1 or anti-PD-1 therapy.
Source: TAISHAN-302
Relevance: supporting · Type: background
Confidence100%
48.8% of patients in the TAISHAN-302 study had platinum-resistant disease.
Source: TAISHAN-302
Relevance: supporting · Type: event
Confidence100%
At the data-cutoff date, the median duration of treatment was 7.2 months in the tambotatug pelitecan group and 2.3 months in the topotecan group in the TAISHAN-302 study.
Source: TAISHAN-302
Relevance: supporting · Type: event
Confidence100%
71 patients (31.6%) in the tambotatug pelitecan group and eight patients (3.5%) in the topotecan group were still receiving the assigned treatment at the data-cutoff date in the TAISHAN-302 study.
Source: TAISHAN-302
Relevance: supporting · Type: event
Confidence100%
Adverse events of grade 3 or higher occurred in 55.4% of the tambotatug pelitecan group and 77.9% of the topotecan group in the TAISHAN-302 study.
Source: TAISHAN-302
Relevance: supporting · Type: event
Confidence100%
Serious adverse events occurred in 38.8% of the tambotatug pelitecan group and 43.3% of the topotecan group in the TAISHAN-302 study.
Source: TAISHAN-302
Relevance: supporting · Type: event
Confidence100%
Dose reductions due to an adverse event occurred in 28.1% of patients in the tambotatug pelitecan group and 37.3% in the topotecan group in the TAISHAN-302 study.
Source: TAISHAN-302
Relevance: supporting · Type: event
Confidence100%
Permanent discontinuation due to an adverse event occurred in 7.1% of the tambotatug pelitecan group and 3.7% of the topotecan group in the TAISHAN-302 study.
Source: TAISHAN-302
Relevance: supporting · Type: event
Confidence100%
Interstitial lung disease or pneumonitis occurred in 4.9% of patients on tambotatug pelitecan and 1.4% on topotecan in the TAISHAN-302 study.
Source: TAISHAN-302
Relevance: supporting · Type: background
Confidence100%
The ARTEMIS-008 multicenter, open-label phase III study randomized 461 patients to receive risvutatug rezetecan 8.0 mg/kg every 3 weeks or topotecan 1.2 mg/m2 on days 1 through 5 every 3 weeks.
Source: ARTEMIS-008 study protocol
Relevance: supporting · Type: background
Confidence100%
The median patient age was 61.5 in the risvutatug rezetecan group and 63 in the topotecan group in the ARTEMIS-008 study.
Source: ARTEMIS-008 study results
Relevance: supporting · Type: background
Confidence100%
Patients who had never smoked accounted for 31% of the study population in the ARTEMIS-008 study.
Source: ARTEMIS-008 study results
Relevance: supporting · Type: background
Confidence100%
More than 80% of patients in the ARTEMIS-008 study had previously received PD-L1 inhibitors.
Source: ARTEMIS-008 study results
Relevance: supporting · Type: event
Confidence100%
Median exposure duration was 6.9 months for risvutatug rezetecan and 2.8 months for topotecan in the ARTEMIS-008 study.
Source: ARTEMIS-008 study results
Relevance: supporting · Type: event
Confidence100%
Grade 3 or higher treatment-related adverse events occurred in 60.9% of patients treated with risvutatug rezetecan versus 78.2% with topotecan in the ARTEMIS-008 study.
Source: ARTEMIS-008 study results
Relevance: supporting · Type: event
Confidence100%
Serious treatment-related adverse events occurred in 34.3% of patients treated with risvutatug rezetecan and 37.5% with topotecan in the ARTEMIS-008 study.
Source: ARTEMIS-008 study results
Relevance: supporting · Type: event
Confidence100%
Adverse events leading to dose reductions occurred in 20.4% of patients in the risvutatug rezetecan group and 38.0% in the topotecan group in the ARTEMIS-008 study.
Source: ARTEMIS-008 study results
Relevance: supporting · Type: event
Confidence100%
Adverse events leading to treatment discontinuation occurred in 9.1% of the risvutatug rezetecan group and 4.2% of the topotecan group in the ARTEMIS-008 study.
Source: ARTEMIS-008 study results
Relevance: supporting · Type: event
Confidence100%
The incidence of interstitial lung disease was 11.7% with risvutatug rezetecan versus 1.9% with topotecan in the ARTEMIS-008 study.
Source: ARTEMIS-008 study results
Relevance: primary · Type: event
Confidence100%
Adding local consolidative therapy after induction treatment with nivolumab plus ipilimumab did not improve overall survival or progression-free survival in patients with metastatic non-small cell lung cancer.
Source: news-medical.net
Relevance: supporting · Type: background
Confidence100%
The LONESTAR trial was a phase III open-label, single-center, randomized trial in immunotherapy-naive patients with metastatic non-small cell lung cancer.
Source: news-medical.net
Relevance: supporting · Type: action
Confidence100%
Mehmet Altan reported the LONESTAR trial results at the World Conference on Lung Cancer in Seoul, South Korea.
Source: World Conference on Lung Cancer proceedings
Relevance: supporting · Type: background
Confidence100%
At the June 15, 2026 data cutoff, 166 patients were randomized in the LONESTAR trial: 83 to nivolumab/ipilimumab alone and 83 to local consolidative therapy followed by nivolumab/ipilimumab.
Source: news-medical.net
Relevance: supporting · Type: background
Confidence100%
Seventy-seven patients had oligometastatic disease at randomization in the LONESTAR trial.
Source: LONESTAR trial results
Relevance: supporting · Type: event
Confidence100%
Sixteen patients in the local consolidative therapy arm underwent surgery and 71 patients received radiation to at least one disease site in the LONESTAR trial.
Source: news-medical.net
Relevance: primary · Type: event
Confidence100%
In the overall randomized population of the LONESTAR trial, median overall survival was 52.8 months with nivolumab/ipilimumab alone compared with 43.2 months with local consolidative therapy plus nivolumab/ipilimumab (HR 1.14; 95% CI, 0.75-1.74; P=.54).
Source: news-medical.net
Relevance: primary · Type: event
Confidence100%
Median progression-free survival was 24.3 months with nivolumab/ipilimumab alone versus 31.3 months with local consolidative therapy plus nivolumab/ipilimumab in the overall LONESTAR trial population (HR 0.79; 95% CI, 0.54-1.15; P=.22).
Source: news-medical.net
Relevance: supporting · Type: event
Confidence100%
Among patients with oligometastatic disease in the LONESTAR trial, median overall survival was 75.8 months with nivolumab/ipilimumab alone versus 42 months with local consolidative therapy plus nivolumab/ipilimumab.
Source: news-medical.net
Relevance: supporting · Type: event
Confidence100%
Among patients with oligometastatic disease in the LONESTAR trial, median progression-free survival was 44.0 months with nivolumab/ipilimumab alone versus 35.7 months with local consolidative therapy plus nivolumab/ipilimumab.
Source: news-medical.net
Relevance: supporting · Type: event
Confidence100%
Local consolidative therapy did not increase the overall incidence of grade 3 or higher adverse events in the LONESTAR trial.
Source: news-medical.net
Relevance: supporting · Type: event
Confidence100%
Pneumonitis occurred in 9.5% of patients in the local consolidative therapy arm compared with 4.9% with nivolumab/ipilimumab alone in the LONESTAR trial.
Source: news-medical.net
Mehmet Altan, MD
Relevance: primary · Type: quote
Confidence100%
"Local consolidative therapy after induction dual checkpoint blockade was feasible, but it did not improve overall survival or progression-free survival in the overall population or among patients with oligometastatic disease."
Source: news-medical.net
Mehmet Altan, MD
Relevance: primary · Type: quote
Confidence100%
"Findings do not support routine local consolidation therapy after ipilimumab and nivolumab induction in metastatic non-small cell lung cancer -- without actionable genomic alteration -- outside of a clinical trial."
Source: medpagetoday.com
Relevance: supporting · Type: action
Confidence100%
The LONESTAR study was closed for futility after enrolling 166 patients.
Source: medpagetoday.com
Relevance: supporting · Type: background
Confidence100%
Eligible patients for the LONESTAR trial had stage IV non-small cell lung cancer, were immunotherapy naïve, and had EGFR/ALK wild-type status.
Source: LONESTAR trial protocol
Relevance: supporting · Type: background
Confidence100%
The median age was 66 in the local consolidative therapy-dual immunotherapy arm and 67 in the nivolumab-ipilimumab alone arm in the LONESTAR trial.
Source: medpagetoday.com
Relevance: supporting · Type: event
Confidence100%
A subgroup analysis showed that only patients under age 65 saw an overall survival benefit with local consolidative therapy-dual immunotherapy in the LONESTAR trial (HR 0.43, 95% CI 0.20-0.93).
Source: medpagetoday.com
Relevance: supporting · Type: event
Confidence100%
A post-hoc analysis demonstrated a link between mediastinal radiation and increased lymphopenia in the local consolidative therapy arm of the LONESTAR trial.
Source: LONESTAR trial results
Relevance: primary · Type: event
Confidence100%
Survival in metastatic non-small cell lung cancer did not improve with the addition of sacituzumab govitecan to pembrolizumab in the EVOKE-03 trial.
Source: EVOKE-03 trial results
Relevance: primary · Type: event
Confidence100%
Median progression-free survival in the EVOKE-03 trial improved from 7.7 months with pembrolizumab alone to 11.8 months with sacituzumab govitecan, but the difference did not meet prespecified criteria for statistical significance.
Source: EVOKE-03 trial results
Relevance: primary · Type: event
Confidence100%
An interim analysis of overall survival in the EVOKE-03 trial showed a slight advantage for the control arm (22.8 vs 21.5 months).
Source: EVOKE-03 trial results
Relevance: supporting · Type: action
Confidence100%
Giannis Mountzios reported the EVOKE-03 trial results at the World Conference on Lung Cancer in Seoul, South Korea.
Source: World Conference on Lung Cancer proceedings
Giannis Mountzios, MD, PhD
Relevance: primary · Type: quote
Confidence100%
"At this primary analysis for PFS, the study did not meet its primary endpoint because the difference was not statistically significant."
Source: medpagetoday.com
Giannis Mountzios, MD, PhD
Relevance: supporting · Type: quote
Confidence100%
"Confirmed objective response rates and disease control rates were numerically higher with the combination than with pembrolizumab monotherapy, and median duration of response was similar between the treatment groups."
Source: medpagetoday.com
Giannis Mountzios, MD, PhD
Relevance: primary · Type: quote
Confidence100%
"At the interim analysis for overall survival, a statistically significant difference for this dual primary endpoint was not met, and it is highly unlikely that it will occur in the future."
Source: medpagetoday.com
Relevance: supporting · Type: background
Confidence100%
Investigators in the EVOKE-03 trial randomized 620 patients to pembrolizumab alone or in combination with sacituzumab govitecan.
Source: EVOKE-03 trial protocol
Relevance: supporting · Type: background
Confidence100%
The primary analysis of the EVOKE-03 trial occurred after a median follow-up of 14.7 months.
Source: EVOKE-03 trial results
Relevance: supporting · Type: event
Confidence100%
The 4.1-month improvement in progression-free survival in the EVOKE-03 trial translated into a hazard ratio of 0.81 in favor of the combination, associated with a P-value of 0.0250.
Source: EVOKE-03 trial results
Relevance: supporting · Type: background
Confidence100%
The EVOKE-03 trial protocol specified a P-value of 0.007 for statistical significance.
Source: EVOKE-03 trial protocol
Relevance: supporting · Type: event
Confidence100%
Objective response rate favored the combination of sacituzumab govitecan and pembrolizumab (55.6% vs 43.7%) in the EVOKE-03 trial.
Source: EVOKE-03 trial results
Relevance: supporting · Type: event
Confidence100%
Disease control rate favored the combination of sacituzumab govitecan and pembrolizumab (83.3% vs 73.1%) in the EVOKE-03 trial.
Source: EVOKE-03 trial results
Relevance: supporting · Type: event
Confidence100%
Duration of response was 21.3-21.4 months in both treatment groups in the EVOKE-03 trial.
Source: EVOKE-03 trial results
Ji-Youn Han, MD, PhD
Relevance: supporting · Type: quote
Confidence100%
"Pembrolizumab monotherapy remains a standard for PD-L1-high groups."
Source: medpagetoday.com
Ji-Youn Han, MD, PhD
Relevance: supporting · Type: quote
Confidence100%
"Sacituzumab govitecan plus pembrolizumab should not be pursued in this setting outside of clinical trials."
Source: medpagetoday.com
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