- |||||||||| Imfinzi (durvalumab) / AstraZeneca
DURVALUMAB ASSOCIATED ACUTE EOSINOPHILIC PNEUMONIA: A CASE REPORT (Convention Center Exhibit Hall: Rapid Fire Area 2B) - Jul 31, 2024 - Abstract #CHEST2024CHEST_1071;
Our case highlights the importance of keeping PD-L1 inhibitors, especially durvalumab as a possible cause of AEP, and to strongly consider alternative therapy if diagnosis is suspected. Prompt therapy with steroids leads to improvement in symptoms and radiographic abnormalities.
- |||||||||| Journal, Metastases: Approaches to Treating High Risk and Advanced Renal Cell Carcinoma (RCC): Key Trial Data That Impacts Treatment Decisions in the Clinic. (Pubmed Central) - Jul 29, 2024
Subsequently, adjuvant pembrolizumab has shown a benefit in overall survival, whereas trials of neoadjuvant and adjuvant nivolumab, adjuvant atezolizumab, and adjuvant ipilimumab plus nivolumab have all been negative...The CARMENA study raised important questions about the role of cytoreductive nephrectomy given the advances in VEGFR TKI therapy but was characterized by accrual difficulties and a significant number of patients not receiving treatment according to the study protocol. Two ongoing studies (NORDIC-SUN and PROBE) seek to further address the role of cytoreductive nephrectomy in the doublet therapy era.
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Review, Journal: Treatment Strategies for Locoregional Recurrence in Esophageal Squamous-Cell Carcinoma: An Updated Review. (Pubmed Central) - Jul 27, 2024
For patients with lymph node recurrence in multiple regions, chemotherapy (5-fluorouracil [5-FU] plus cisplatin) and combination therapy with nivolumab and ipilimumab have shown comparable oncological efficacy. Further prospective studies are needed to improve the treatment outcomes in patients with esophageal cancer with locoregional recurrence.
- |||||||||| Journal, Adverse events, Checkpoint inhibition: Adverse Events of PD-1, PD-L1, CTLA-4, and LAG-3 Immune Checkpoint Inhibitors: An Analysis of the FDA Adverse Events Database. (Pubmed Central) - Jul 26, 2024
The LAG-3 inhibitor relatlimab reported fewer AEs, including pyrexia and pneumonia...This study provides a detailed overview of the 25 most common AEs associated with ICIs, offering valuable insights for clinical decision-making and AE management. Further research is necessary to elucidate the mechanisms underlying these AEs and to develop targeted interventions to enhance the safety and efficacy of ICI therapy in patients with cancer.
- |||||||||| Clinical, Retrospective data, Review, Journal, PD(L)-1 Biomarker, IO biomarker, Metastases: Efficacy and safety evaluation of frontline immunotherapy combinations in advanced esophageal squamous cell carcinoma: a network meta-analysis highlighting the value of PD-L1 expression positivity scores. (Pubmed Central) - Jul 26, 2024
In advanced ESCC patients irrespective of PD-L1 expression, both sintilimab-chemotherapy and toripalimab-chemotherapy regimens demonstrated comparable OS benefits (HR=0.92, 95% CI: 0.64-1.33)...Notably, camrelizumab-chemotherapy (HR=0.83, 95% CI: 0.59-1.16) and nivolumab-ipilimumab (HR=0.84, 95% CI: 0.60-1.17) demonstrated significant safety profiles over chemotherapy alone...Among patients with PD-L1 expression ?10%, camrelizumab-chemotherapy (HR=0.52, 95% CI: 0.35-0.78) emerged as the most efficacious in improving OS, while serplulimab-chemotherapy (HR=0.48, 95% CI: 0.34-0.68) was associated with the longest PFS benefit...Since most of the patients in this study originated from Asia, the above findings are more applicable to the Asian population. https://www.crd.york.ac.uk/prospero/, identifier CRD42024504992.
- |||||||||| Yervoy (ipilimumab) / BMS
A randomized phase I/II study of neoadjuvant therapy with [ 177Lu ] Lu -PSMA-617) with or without ipilimumab in patients with high-risk prostate cancer who are candidates for radical prostatectomy (NEPI Trial) CA184-608, EudraCT No.: 2021-004894-30 (Foyer Hall 1) - Jul 26, 2024 - Abstract #DGU2024DGU_451;
The only moderate effectiveness of checkpoint inhibitors in prostate cancer can be enhanced by synergistic radiotherapy.Materials and Patients with operable high-risk prostate cancer (ISUP-GG 4+5 and cT3 plus cN+ or PSA > 20ng/ml) receive neoadjuvant treatment with ADT plus [177Lu]Lu-PSMA-617 (LuPSMA) with randomized allocation with or without ipilimumab.The safety and feasibility of the combination will be reviewed after 6-12 patients based on the severity of toxicity or delay in operability (max. Co-primary endpoints of the study are the feasibility of radical prostatectomy after the above-mentioned neoadjuvant therapy, as well as the complete pathological response.Secondary endpoints are the evaluation of the safety profile of the neoadjuvant treatment according to the "National Cancer Institute Common Terminology Criteria for Adverse Events" (NCI CTCAE) v5.0 and disease-free survival.Hypothesis (conclusion): Since both ipilimumab in combination with radiotherapy and LuPSMA have been shown to be effective in prostate cancer, we propose the Hypothesized that CTLA-4 inhibitors have synergistic effects on tumor damage and immune priming induced by LuPSMA radioligand therapy.
- |||||||||| Opdivo (nivolumab) / BMS, Cabometyx (cabozantinib tablet) / Exelixis, Yervoy (ipilimumab) / BMS
Trial completion date, Trial primary completion date: A Phase II Study of Nivolumab with Ipilimumab and Cabozantinib in Patients with Untreated Renal Cell Carcinoma Brain Metastases (clinicaltrials.gov) - Jul 26, 2024
P2, N=40, Recruiting,
Co-primary endpoints of the study are the feasibility of radical prostatectomy after the above-mentioned neoadjuvant therapy, as well as the complete pathological response.Secondary endpoints are the evaluation of the safety profile of the neoadjuvant treatment according to the "National Cancer Institute Common Terminology Criteria for Adverse Events" (NCI CTCAE) v5.0 and disease-free survival.Hypothesis (conclusion): Since both ipilimumab in combination with radiotherapy and LuPSMA have been shown to be effective in prostate cancer, we propose the Hypothesized that CTLA-4 inhibitors have synergistic effects on tumor damage and immune priming induced by LuPSMA radioligand therapy. Trial completion date: Jul 2024 --> Dec 2025 | Trial primary completion date: Jul 2024 --> Dec 2025
- |||||||||| abequolixron (RGX-104) / Inspirna
Enrollment closed, Trial completion date, Trial primary completion date, Metastases: A Study of RGX-104 in Patients With Advanced Lung & Endometrial Cancer (clinicaltrials.gov) - Jul 25, 2024
P1, N=146, Active, not recruiting,
Trial completion date: Jul 2024 --> Dec 2025 | Trial primary completion date: Jul 2024 --> Dec 2025 Recruiting --> Active, not recruiting | Trial completion date: May 2024 --> Sep 2024 | Trial primary completion date: Dec 2023 --> Sep 2024
- |||||||||| Opdivo (nivolumab) / BMS, Cabometyx (cabozantinib tablet) / Exelixis, Yervoy (ipilimumab) / BMS
Trial completion, Trial completion date, Trial primary completion date: Study of Ipilimumab, Nivolumab, and Cabozantinib in Patients With Cutaneous Melanoma (clinicaltrials.gov) - Jul 24, 2024
P2, N=4, Completed,
Recruiting --> Active, not recruiting | Trial completion date: May 2024 --> Sep 2024 | Trial primary completion date: Dec 2023 --> Sep 2024 Active, not recruiting --> Completed | Trial completion date: Jun 2031 --> Jul 2024 | Trial primary completion date: Jun 2027 --> Sep 2023
- |||||||||| relatlimab (BMS-986016) / BMS, Ono Pharma, Yervoy (ipilimumab) / BMS
Phase classification, Trial termination, Combination therapy, Metastases: A Study to Assess Safety of Relatlimab With Ipilimumab in Participants With Advanced Melanoma Who Progressed on Anti-Programmed Cell Death Protein 1 (Anti-PD-1) Treatment (clinicaltrials.gov) - Jul 24, 2024
P1, N=11, Terminated,
Furthermore, an NLR of???4.8 and CRP of???1.0 Phase classification: P1/2 --> P1 | Completed --> Terminated; Business objectives have changed.
- |||||||||| seribantumab (MM-121) / Elevation Oncology
Seribantumab Results in Robust and Durable Responses in NRG1 Fusion-Positive Non-Small Cell Lung Cancer: A Multi-Center Case Series (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_2509;
Targeted agents, such as the pan-ERBB kinase inhibitor afatinib, fare slightly better, with an ORR in the eNRGy1 registry of 25%...Following four cycles of neoadjuvant intent cisplatin/pemetrexed/durvalumab therapy, resection was aborted when pleural studding was noted intraoperatively, pathologically confirmed as adenocarcinoma...He was initially treated with dual immunotherapy (nivolumab/ipilimumab), then an investigational PGE2-receptor antagonist in combination with pembrolizumab...Patient three was a 59-year-old woman with bilateral metastatic recurrence of NSCLC, ITGB1-NRG1 fusion, previously treated with multiple resections, radiation, and systemic therapy including carboplatin/pemetrexed and nivolumab with progression...Conclusions : NRG1 fusion-positive lung cancer remains a challenging clinical entity, with poor response to standard-of-care therapy in the advanced and metastatic setting. In patients with lung cancer positive for various NRG1-fusions with progression on prior lines of therapy, inhibition of HER3 with seribantumab has resulted in deep and prolonged responses, representing a promising treatment for this unique group of patients.
- |||||||||| volrustomig (MEDI5752) / AstraZeneca
eVOLVE-Meso: A Global Phase 3 Study of First-Line Volrustomig Plus Chemotherapy in Unresectable Pleural Mesothelioma (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_2463;
P1, P3
In patients with lung cancer positive for various NRG1-fusions with progression on prior lines of therapy, inhibition of HER3 with seribantumab has resulted in deep and prolonged responses, representing a promising treatment for this unique group of patients. Approximately 600 patients will be randomized in a 1:1 ratio to volrustomig + carboplatin + pemetrexed; or investigator
- |||||||||| Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
A Real-World Multicenter Retrospective Study of Treatment Outcomes with Ipilimumab and Nivolumab in Mesothelioma (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_2457;
However, more irAEs including grade 3 or 4 toxicities were noted in the PL group bringing to light the potential benefit of upfront I/N rather than upon progression on systemic chemo in-terms of tolerability. This is the first real world study conducted in the US evaluating the outcomes of patients with unresectable mesothelioma.
- |||||||||| Avastin (bevacizumab) / Roche, Kaitanni (cadonilimab) / Akesobio
Cadonilimab Plus Bevacizumab and Chemotherapy as First Line Therapy in Unresectable Pleural Mesothelioma: A Single-Arm Phase II Study (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_2297;
P2
The immunotherapies nivolumab and ipilimumab improved survival compared with platinum-pemetrexed, particularly in non-epithelioid histology...Patients will receive carboplatin AUC 5, pemetrexed 500 mg/m2, bevacizumab 7.5 mg/kg, cadonilimab 10 mg/kg intravenously on day 1 of a 3-weekly schedule for a maximum of six cycles...A total of 38 patients will be recruited to account for dropout. Enrolment began in November 2023 and the study is currently ongoing.
- |||||||||| Avastin (bevacizumab) / Roche, Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Clinical Insights and Survival Outcomes of Malignant Pleural Mesothelioma: An Experience from a Tertiary Care Centre in India (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_2278;
Of 25 patients 18 (72%) received systemic chemotherapy, with pemetrexed-platinum (either cis- or carbo-platin)...10 patients received subsequent lines of systemic therapy which included immunotherapy (nivolumab + ipilimumab), gemcitabine (with or without bevacizumab) and oral metronomic therapy (containing cyclophosphamide, etoposide and pazopanib)...Conclusions : With the response rates of 44.4% and median survival of 26 months, the outcomes of systemic therapy in MPM are comparable with the global population. Given the aggressive nature and grim prognosis of the disease, it is imperative to advance our comprehension of its biology and treatment efficacy factors.
- |||||||||| Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Effect of Cytotoxic Chemotherapy Following Ipilimumab Puls Nivolumab Combination Therapy for Malignant Pleural Mesothelioma (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1630;
As for safety, serious adverse events were observed in 3 patients, one anaphylactic shock and two grade 3 or higher renal dysfunction, which compelled treatment discontinuation. Conclusions : Our findings suggest that the effectiveness of platinum plus pemetrexed successive to ipilimumab plus nivolumab was comparable to the data of first-line cisplatin plus pemetrexed reported in EMPHACIS study in which the mPFS was 5.7 months.
- |||||||||| Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Incidence of Pseudoprogression and Hyperprogression in Patients with Pleural Mesothelioma Treated with Ipilimumab and Nivolumab (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1625;
The relatively high incidence of pseudoprogression we observed suggests that in the absence of significant clinical deterioration, PM patients on immunotherapy with suspected disease progression at the initial scan should consider continuing treatment until subsequent imaging is performed. Ongoing analyses evaluate the impact of hyperprogression on overall survival; correlate the incidence of pseudoprogression with objective response rate, response duration, and overall survival; and employ radiomics to discriminate between pseudoprogression and true progression.
- |||||||||| Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Incidence of Pseudoprogression and Hyperprogression in Patients with Pleural Mesothelioma Treated with Ipilimumab and Nivolumab (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1614;
The relatively high incidence of pseudoprogression we observed suggests that in the absence of significant clinical deterioration, PM patients on immunotherapy with suspected disease progression at the initial scan should consider continuing treatment until subsequent imaging is performed. Ongoing analyses evaluate the impact of hyperprogression on overall survival; correlate the incidence of pseudoprogression with objective response rate, response duration, and overall survival; and employ radiomics to discriminate between pseudoprogression and true progression.
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Comparison of Immunotherapy for Metastatic Non-Small Cell Lung Cancer in Real-World Practice: A Japanese Registry Study (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1174;
Conclusions : Our findings suggest that immune-chemo therapy, particularly pembrolizumab combined with chemotherapy, significantly enhances OS in stage IV NSCLC patients without driver alterations who are eligible for chemotherapy. This advantage was not observed with the combination of nivolumab and ipilimumab with chemotherapy, highlighting the importance of regimen selection in this patient population.
- |||||||||| NSCLC Immune Hemogram Index (NIHX) A Predictive Score for Immunotherapy Response in PD-L1 Negative Advanced NSCLC (Exhibit Hall) - Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_1171;
Conclusions : Our study demonstrates that pretreatment NIHX, based on NLR and PLR, serves as a promising predictive tool for treatment response in PD-L1 negative advanced NSCLC patients. NIHX stratification into good, intermediate, and poor groups correlates with PFS and RR, highlighting its potential utility in guiding ICI therapy selection for this patient population.
- |||||||||| Inlyta (axitinib) / Pfizer, Yervoy (ipilimumab) / BMS
Trial completion date, Trial primary completion date, Metastases: Axitinib + Ipilimumab in Advanced Melanoma (clinicaltrials.gov) - Jul 24, 2024
P2, N=25, Recruiting,
Conclusions : This study provides the first real-world data on subsequent treatment options for patients with PM who progressed on nivo/ipi, with a mOS of 8.2 months after second-line chemotherapy. Trial completion date: Aug 2027 --> Mar 2027 | Trial primary completion date: Aug 2024 --> Mar 2026
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Leukine (sargramostim) / Partner Therap, Yervoy (ipilimumab) / BMS
Enrollment closed, Trial completion date, Trial primary completion date, Metastases: Metastatic Solid Cancer Clinical Trial (clinicaltrials.gov) - Jul 23, 2024
P2, N=32, Active, not recruiting,
The detection of even subtle abnormalities in these parameters should prompt immediate consultation with an endocrinologist. Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024
- |||||||||| Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Enrollment closed, Enrollment change: ATLAS: Study of Nivolumab-Ipilimumab and cfDNA in Lung Cancer (clinicaltrials.gov) - Jul 22, 2024
P2, N=5, Active, not recruiting,
Phase classification: P1/2 --> P2 Recruiting --> Active, not recruiting | N=50 --> 5
- |||||||||| relatlimab (BMS-986016) / BMS, Opdivo (nivolumab) / BMS, Yervoy (ipilimumab) / BMS
Enrollment change, Trial completion date, Trial termination, Trial primary completion date: T-cell Therapy in Combination With Nivolumab, Relatlimab and Ipilimumab for Patients With Metastatic Ovarian Cancer (clinicaltrials.gov) - Jul 22, 2024
P1/2, N=5, Terminated,
Recruiting --> Active, not recruiting | N=50 --> 5 N=18 --> 5 | Trial completion date: Dec 2023 --> Jul 2024 | Recruiting --> Terminated | Trial primary completion date: Dec 2022 --> Mar 2024; Slow recruitment
- |||||||||| Retrospective data, Review, Journal, Metastases: Radiation and systemic immunotherapy for metastatic uveal melanoma: a clinical retrospective review. (Pubmed Central) - Jul 19, 2024
The only FDA approved immunotherapy medication for metastatic uveal melanoma is the HLA-A02:01 restricted bispecific T cell engager drug, Tebentafusp...Twenty-three (92%) patients received systemic therapy, 13 patients (52%) received ipilimumab-nivolumab as the first-line, while 4 patients (16%) received pembrolizumab...Within our cohort, there was no overall survival benefit for patients receiving treatment of metastatic disease within 6 months of mUM diagnosis, versus those electing later or no treatment at all. There was remarkable clinical activity of ipilimumab and nivolumab in a subset of patients with mUM, in agreement with prior studies, and metastatic PD-L1 positive tumors were associated with a prolonged survival.
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