The phase II trial aimed to evaluate the combined efficacy and safety of TUC and Tras in HER2-altered solid tumor pts.
The primary endpoint was cORR. Secondary endpoints include OS, DCR, DOR, PFS, and safety.
The study found that combined therapy was well-tolerated and showed promising antitumor activity in pts.

Biliary tract cancer (BTC) is a deadly cancer with few treatment options. Tucatinib (TUC) is a drug that targets HER2, a protein that is often found in BTC.

Researchers aimed to evaluate the combined efficacy and safety of TUC and Trastuzumab (Tras) in patients (pts) with HER2-altered solid tumors.

The study included pts who had previously received and experienced disease progression after one or more lines of systemic therapy for metastatic disease. The eligible pts need to have locally confirmed HER2-positive status, either HER2 overexpression (assessed by immunohistochemistry as 3+) or HER2 amplification (determined through in situ hybridization assay or next-generation sequencing).

Treatment consisted of a 21-day cycle involving the oral drug TUC (300 mg taken twice daily) and intravenous Tras (starting with 8 mg/kg followed by 6 mg/kg every 3 weeks). Disease status was assessed using RECIST v1.1 criteria, with evaluations conducted every 6 weeks for the first 24 weeks and then every 12 weeks. The primary endpoint was the confirmed objective response rate (cORR) determined by the investigator. Secondary endpoints included overall survival (OS), disease control rate (DCR), duration of response (DOR), progression-free survival (PFS), and safety.

About 30 pts were enrolled in the BTC cohort. The median follow-up duration was 8.3 months. The cORR was 46.7% [90% CI, 30.8, 63.0], with 14 responses, including 1 complete and 13 partial responses. The median DOR was 6.0 months [90% CI, 5.5, not estimable]. The DCR was 76.7% (n=23; 90% CI, 60.6, 88.5), and the median PFS was 5.5 months [90% CI, 3.9, 8.1]. At the data cutoff, 13 pts (43.3%) had passed away, and the 12-month OS rate was 53.8% [90% CI, 35.2, 69.1%]. The most commonly reported treatment-emergent adverse events (TEAEs) were pyrexia (43.3%) and diarrhea (40.0%). Grade ≥3 TEAEs were reported in 18 (60.0%) of 30 pts; however, only 6 (20.0%) and 2 (6.7%) of these pts had Grade ≥3 TEAEs related to TUC and Tras, respectively, 2 pts (6.7%) discontinued TUC due to TEAEs, specifically cholangitis and liver disorder. No deaths were attributed to TEAEs.

The study found that combined therapy was well-tolerated and showed promising antitumor activity in pts.

Source: https://ascopubs.org/doi/abs/10.1200/JCO.2023.41.16_suppl.4007

Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT04579380

Yoshiaki Nakamura, Nobumasa Mizuno, Yu Sunakawa, Erika P. Hamilton, Hidetoshi Hayashi, Seung Tae Kim, Keun-Wook Lee, Bradley J. Monk, Danny Nguyen, Alicia Frances Clare Okines, David M. O’Malley, Paula R Pohlmann, Martin Reck, Evan Y. Yu, Roman Groisberg, Jorge Ramos, Qianwen Tan, Tom Stinchcombe, and Tanios S. Bekaii-Saab. DOI: 10.1200/JCO.2023.41.16_suppl.4007 Journal of Clinical Oncology 41, no. 16_suppl (June 01, 2023) 4007-4007.

Amivantamab Shows Efficacy In Pts With Advanced NSCLC

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The phase 1 CHRYSALIS study evaluated amivantamab (ami) for treating advanced non-small cell lung cancer with EGFR Ex20ins mutations.
Patients who had experienced disease progression on platinum-based chemotherapy were enrolled in the study.
The study demonstrated the effectiveness of amivantamab in treating advanced NSCLC with EGFR Ex20ins mutations across diverse patient groups and prior treatment backgrounds.

The CHRYSALIS study reported the long-term outcomes of utilizing amivantamab (ami) to treat advanced non-small cell lung cancer (NSCLC).

Patients with EGFR Ex20ins advanced NSCLC who had experienced disease progression on platinum-based chemotherapy were selected for recruitment in the CHRYSALIS study. Those who were administered the approved phase II dose of 1050 mg (1400 mg if their weight was ≥80 kg) by June 8, 2020, were eligible for inclusion. The investigator evaluated the response to the treatment.

The trial included 114 individuals, with a median follow-up duration of 19.2 mo and 48 (42%) pts alive. Investigators assessed the overall response rate (ORR) at 37% (95% CI, 28-46) with a median duration of response at 12.5 months (95% CI, 6.9-19.3), the median progression-free survival (PFS) was 6.9 months (95% CI, 5.6-8.8), and the median overall survival was 23 months (95% CI, 18.5-29.5). The activity was observed across all subgroups, including the elderly (with an ORR of 32% and 33% for age ≥65 and ≥75, respectively), heavily pretreated pts (with an ORR of 53% for >2 prior lines, 42% for prior immunotherapy, and 52% for prior EGFR TKI therapy), or those sensitive or resistant to prior platinum-based chemotherapy (with an ORR of 36% and 31%, respectively). No new safety concerns were found. Rash (89%) and infusion reactions (67%) were common side effects. 42% of pts (n=48) were administered ami for 12+ cycles (28-day). Additionally, 13% of pts (n=15) are still undergoing treatment, with 11 positive responses and four with stable diseases. Patients took ami for a median of 2.6 years. An analysis will be presented by comparing sustained clinical benefit vs. no benefit (≥12 cycles on ami), including plasma ctDNA data.

Ami showed efficacy in post-platinum pts suffering from EGFR Ex20ins NSCLC, regardless of age, prior treatments, platinum sensitivity, or refractory status. Moreover, a subgroup of pts experienced extended benefits, which will undergo further scrutiny and examination.

Source: https://oncologypro.esmo.org/meeting-resources/european-lung-cancer-congress/long-term-efficacy-safety-and-predictors-of-response-to-amivantamab-among-patients-with-post-platinum-egfr-ex20ins-mutated-advanced-nsclc

Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT02609776

Lopez, P.G., Girard, N., Cho, B.C., Sabari, J., Spira, A., Sanborn, R.E.E., Goto, K., Yang, J.C., Curtin, J., Lyu, X., He, A., Penton, J., Edwards, J., Massin, G.L., Xia, K., Chioda, M., Thayu, M., Knoblauch, R.E., Mahadevia, P., Leighl, N. Journal of Thoracic Oncology (2023).

PSCA-Targeted CAR T Cells Show Promise in mCRPC Patients

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The phase I trial aimed to evaluate the safety and efficacy of PSCA-targeted 4-1BB-co-stimulated CAR T cell therapy in patients with mCRPC.
CAR T cells were manufactured and infused into patients with disease progression after at least 1 androgen receptor-targeted therapy.
The study found that PSCA-CAR T cells can potentially treat mCRPC, but a lower therapy dose may be more beneficial.

Prostate stem cell antigen (PSCA) is a good target for chimeric antigen receptor (CAR) T cell therapy in metastatic castration-resistant prostate cancer (mCRPC). The study aimed to evaluate the safety and efficacy of PSCA-targeted 4-1BB-co-stimulated CAR T cell therapy in patients with mCRPC.

The study included the CAR T cells manufactured at City of Hope’s cGMP facility and infused into patients with disease progression after at least 1 androgen receptor-targeted therapy. The primary objective was to identify dose-limiting toxicities (DLT) and outline initial bioactivity and effectiveness. CAR T-cell persistence and cytokine levels were assessed using flow cytometry and Luminex. Circulating tumor cells (CTC) were measured using an unselected assay by Kuhn’s method.

Results demonstrated that 14 patients received treatment, with a median age of 69 and a median baseline PSA of 88. Among them, 12 (86%) had prior chemotherapy, mostly with taxanes. The majority of screened patients showed significant PSCA expression. Initial lymphodepletion (LD) dosing led to severe side effects, so the protocol was adjusted to a reduced dose of 300 mg/m² cyclophosphamide on Days 1-3. In fact, no severe side effects occurred after the adjustment. Treatment showed positive outcomes in terms of CAR T cell expansion, PSA levels, and cytokine release, especially in patients with anti-tumor effects. Decreases in cancer cells were observed in both bone marrow and peripheral blood.

The study found that PSCA-CAR T cells exhibit anti-cancer effects in mCRPC, though they lead to severe cystitis. Lowering the LD dose decreases toxicity while maintaining expansion and activity.

Source: https://ascopubs.org/doi/abs/10.1200/JCO.2023.41.16_suppl.5019#:~:text=Conclusions%3A%20PSCA%2DCAR%20T%20cells,Clinical%20trial%20information%3A%20NCT03873805.

Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT03873805

Tanya B. Dorff, Suzette Blanchard, Hripsime Martirosyan, Lauren Adkins, Gaurav Dhapola, Stephanie Shishido, Jamie R Wagner, Tracey Stiller, Massimo D’Apuzzo, Peter Kuhn, Stephen J. Forman, and Saul Priceman. DOI: 10.1200/JCO.2023.41.16_suppl.5019 Journal of Clinical Oncology 41, no. 16_suppl (June 01, 2023) 5019-5019.

CheckMate 214 Study: Clinical Efficacy of NIVO+IPI in sRCC Patients

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Phase 3 of CheckMate 214 trial was conducted to study the long-term efficacy and suitability of NIVO+IPI as a 1L treatment for patients with Untreated Advanced or Metastatic Renal Cell Carcinoma with Sarcomatoid features.
139 patients were randomized in an open-label trial to compare the NIVO+IPI combination with SUN monotherapy, where NIVO+IPI proved superior in terms of OS, PFS, and ORR.
The minimum follow-up of Phase 3 was 5 years, in which the efficacy benefits of NIVO+IPI were maintained irrespective of the tumor PD-L1 expression. However, the magnitude of benefits was greater among tumor PD-L1 ≥ 1% of patients. No new safety signals were discovered in the longer follow-up.

In the CheckMate 214 study, Nivolumab plus Ipilimumab (NIVO+IPI) was explored as a first-line treatment and therapeutic option for patients with advanced RCC (renal cell carcinoma) with Sarcomatoid features (sRCC) with no prior treatments as an alternative to Sunitinib (SUN) treatment. Phase 3 of the study was an exploratory analysis with a minimum follow-up of 5 years to report the long-term efficacy of NIVO+IPI.

In this trial, 139 patients were identified with intermediate/poor-risk sRCC by reviewing the tumor tissue or as per the classification in the local pathology report. They were randomized into the two arms of the study, with the NIVO+IPI arm (n=74) receiving four doses of 3mg/kg NIVO with 1mg/kr IPI every 3 weeks, followed by 3mg/kg NIVO every 2 weeks. And the SUN arm (n=65) received a daily dose of 50mg SUN for 4 weeks in 6-week cycles.

The primary endpoints of the trial were the Overall Survival (OS), Progression-Free Survival (PFS), and Objective Response Rate (ORR) measured using the Response Evaluation Criteria in Solid Tumors V.1.1. The safety outcomes were reported based on the evaluation of these results.

The median OS of NIVO+IPI versus SUN was 48.6 vs 14.2 months (HR 0.46) at 5 years minimum follow-up. The median PFS and ORR were 26.5 vs 5.5 months (HR 0.50) and 60.8% vs 23.1%, respectively. 12% of the NIVO+IPI patients chose to remain on treatment at the 5 years data cutoff, while none of the SUN patients did so. The median DOR was longer with NIVO+IPI patients (not reached vs 25.1 months), with more patients completing responses (23.0% vs 6.2%). The OS, PFS, and ORR benefits of the NIVO+IPI treatment were greater among sRCC patients with tumor PD-L1 expression of ≥1%. However, NIVO+IPI remained superior irrespective of the tumor PD-L1 expression.
The primary results were supported in this 5 years follow-up data, demonstrating the superior long-term efficacy, durability, and tolerability of the NIVO+IPI combination over SUN as the preferred first-line therapy for previously untreated patients with intermediate/poor-risk sRCC.

Source Link: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9791431/

Trial Link: https://clinicaltrials.gov/ct2/show/NCT02231749

Citation: Rini, B. I., Signoretti, S., Choueiri, T. K., McDermott, D. F., Motzer, R. J., George, S., Powles, T., Donskov, F., Tykodi, S. S., Pal, S. K., Gupta, S., Lee, C. W., Jiang, R., & Tannir, N. M. (2022). Long-term outcomes with nivolumab plus ipilimumab versus sunitinib in first-line treatment of patients with advanced sarcomatoid renal cell carcinoma. Journal for immunotherapy of cancer, 10(12), e005445. https://doi.org/10.1136/jitc-2022-005445

ctDNA Testing in mCRPC Patients with HRR Gene Alterations

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The phase 3 PROfound study included patients with mCRPC whose plasma samples were retrospectively sequenced using circulating tumor DNA (ctDNA) Next-Generation Sequencing (NGS) to test for BRCA/ATM alterations.
The efficacy of Olaparib was consistent, irrespective of the method used to identify the BRCA/ATM alterations.
The study demonstrated that ctDNA NGS might be used to identify mCRPC patients with BRAC/ATM alterations as an alternative to tissue-based NGS testing.

The Phase III PROfound study was conducted to demonstrate the clinical utility of identifying patients with metastatic Castration-Resistant Prostate Cancer (mCRPC) and BRCA1, BCRA2, and ATM (BRCA/ATM) alterations who may be eligible for Olaparib treatment, using the circulating tumor DNA (ctDNA) Next-Generation Sequencing (NGS) testing instead of tumor-based NGS testing. Additionally, the efficacy of Olaparib was evaluated as compared to Abiraterone or Enzalutamide (control) in treating patients with mCRPC with tumor Homologous Recombination Repair (HRR) gene alterations.

During the screening of the study, plasma samples were collected and later retrospectively sequenced to test for BRCA1, BRCA2 (BRCA), and ATM alterations in ctDNA with the help of the FoundationOne®Liquid CDx test. The patients who tested positive for BRCA/ATM alterations in the tissue testing were grouped in Cohort A (n=245), and only these patients were evaluated.

73.9% of the Cohort A patients (n=181) consented to plasma sample ctDNA testing. 76.8% of them (139 patients) yielded a result with 111 patients (79.9%) identified with BRCA/ATM alterations. These patients were then grouped into the ctDNA group (n=73) and received Olaparib. The remaining 38 patients received the control drug. Notably, the characteristics and baseline demographics of the patients, along with the prevalence of the HRR alterations, were at par with the Cohort A ITT (intention-to-treat) population.

Clinical outcomes of Cohort A and ctDNA subgroup were compared. The Radiological Progression Free Survival (rPFS) was the primary outcome measure and was longer in the Olaparib group at a median of 7.4 versus 3.5 months in the control group and hazard ratio (HR), 0.33; 95% confidence interval (CI), 0.21–0.53; nominal P < 0.0001. The results of the Cohort A ITT population were consistent at HR, 0.34; 95% CI, 0.25–0.47.

The Phase III PROfound study was concluded with the observation that ctDNA NGS testing proved to be a reliable alternative to testing the BRAC/ATM alterations in mCRPC patients that are eligible for Olaparib treatments when Tumor Tissue Testing has failed or is not feasible. The testing method does not affect the efficacy of the Olaparib treatment.

Source: https://aacrjournals.org/clincancerres/article/29/1/92/711958/Olaparib-Efficacy-in-Patients-with-Metastatic

Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT02987543

Citation: Matsubara, N., de Bono, J., Olmos, D., Procopio, G., Kawakami, S., Ürün, Y., van Alphen, R., Flechon, A., Carducci, M. A., Choi, Y. D., Hotte, S. J., Korbenfeld, E., Kramer, G., Agarwal, N., Chi, K. N., Dearden, S., Gresty, C., Kang, J., Poehlein, C., Harrington, E. A., … Hussain, M. (2023). Olaparib Efficacy in Patients with Metastatic Castration-resistant Prostate Cancer and BRCA1, BRCA2, or ATM Alterations Identified by Testing Circulating Tumor DNA. Clinical cancer research : an official journal of the American Association for Cancer Research, 29(1), 92–99. https://doi.org/10.1158/1078-0432.CCR-21-3577

Comparing HRQOL in R/R Large B-cell Lymphoma: Liso-cel vs SOC

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A phase 3 clinical trial (TRANSFORM) was conducted to evaluate the efficacy of liso-cel compared to SOC as second-line therapy for relapsed/refractory LBCL.
HRQOL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire – 30 items and the Functional Assessment of Cancer Therapy-Lymphoma subscale.
Results revealed a significant improvement in global health status/quality of life (QOL) for the liso-cel arm compared to the SOC arm from day 126 to month 6.
Mean scores for other domains were maintained or improved in both arms.
The study indicated that HRQOL was either improved or maintained from baseline in patients with relapsed/refractory LBCL in the liso-cel arm versus SOC arm as second-line treatment.

Lisocabtagene maraleucel (liso-cel) has demonstrated encouraging efficacy in clinical trials for individuals with relapsed or refractory large B-cell lymphoma (LBCL). The health-related quality of life (HRQOL) results presented here are from the TRANSFORM study, the first to directly compare liso-cel to SOC as second-line therapy for this group of patients.

Patients who had LBCL that had been resistant to or had relapsed ≤ 12 months after first-line therapy and were candidates for autologous stem cell transplantation were randomly assigned to receive either liso-cel or SOC at a 1:1 ratio (3 cycles of immunochemotherapy in which responders proceeded to high-dose chemotherapy and autologous stem cell transplantation). Human health quality of life was evaluated using the Functional Assessment of Cancer Therapy–Lymphoma subscale and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (30-item version).

Patients with ≥ 1 examination postbaseline were considered (liso-cel, n = 47; SOC, n = 43). Significantly more patients in the liso-cel arm than in the SOC arm experienced notable improvement in global health status/quality of life (QOL) from day 126 to month 6, while fewer patients in the SOC arm experienced deterioration. When compared between the two groups, significant declines in global health status/QOL at month 6, fatigue at day 29 and month 6, and pain at month 6 with SOC were observed, while scores for all other domains were either stable or better.

Time to confirm deterioration in global health status/QOL was longer in the liso-cel arm than in the SOC arm (median: not reached vs. 19.0 weeks, respectively; hazard ratio, 0.47; 95% confidence range, 0.24-0.94). Patients with relapsed or resistant LBCL treated with liso-cel as second-line therapy had better HRQOL than those treated with SOC.

Source: https://ashpublications.org/bloodadvances/article/6/23/5969/486699/Health-related-quality-of-life-with-lisocabtagene

Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT03575351

Abramson JS, Johnston PB, Kamdar M, Ibrahimi S, Izutsu K, Arnason J, Glass B, Mutsaers P, Lunning M, Braverman J, Liu FF, Crotta A, Montheard S, Previtali A, Guo S, Shi L, Solomon SR. Health-related quality of life with lisocabtagene maraleucel vs standard of care in relapsed or refractory LBCL. Blood Adv. 2022 Dec 13;6(23):5969-5979. doi: 10.1182/bloodadvances.2022008106. PMID: 36149968; PMCID: PMC9713278.

Clinical Outcomes with High-Dose Once-Daily Thoracic Radiotherapy

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The phase 3 trial (CALGB 30610/RTOG 0538) assessed the efficacy of higher-dose once-daily radiotherapy versus twice-daily radiotherapy in patients with limited-stage small-cell lung cancer.
Results showed that overall survival was not improved on the once-daily arm, with a median survival of 28.5 and 30.1 months and 5-year OS of 29% and 32% for twice-daily and once-daily treatment, respectively.
This study provides essential information to guide radiotherapy decisions for limited-stage small-cell lung cancer.

Although 45 Gy of radiation twice a day is supported by level 1 evidence as the standard for limited-stage small-cell lung cancer, most patients undergo higher-dose once-daily regimens. Whether or not a higher dose of radiation results in better outcomes remains unproven.

CALGB 30610/RTOG 0538 was two stages, phase III clinical investigation. Beginning with the first or second of four total rounds of chemotherapy, individuals with limited-stage illness were randomly assigned to undergo 45-Gy twice daily, 70-Gy once daily, or 61.2-Gy concomitant-boost radiation. After the interim toxicity analysis was completed as scheduled, the 61.2-Gy arm was removed from the study, and the other 2 arms continued. The primary endpoint was overall survival (OS) in the study’s primary analysis population.

Accrual in the trial began on March 15, 2008, and ended on December 1, 2019. All 313 patients who received 45 Gy twice daily and 325 patients who received 70 Gy once daily were included in this study. There was no difference in OS between the once-daily and twice-daily groups after a median follow-up of 4.7 years (hazard ratio for death, 0.94; 95% CI, 0.76 to 1.17; P =.594). The 5-year OS rates are 29% for those who receive treatment twice daily and 32% for those who receive treatment once daily. The median survival time for both treatment schedules is 28.5 months. Tolerability was high, with both groups experiencing an exact rate of severe side events such as esophageal and pulmonary toxicity.

This study offers the most comprehensive evidence available to guide the choice of thoracic radiation regimen for patients with limited-stage small-cell lung cancer, even if 45-Gy twice-daily radiotherapy remains the standard of care.

Source:https://ascopubs.org/doi/10.1200/JCO.22.01359?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed

Clinical Trial: https://clinicaltrials.gov/ct2/show/NCT00632853

Bogart J, Wang X, Masters G, Gao J, Komaki R, Gaspar L, Heymach J, Bonner J, Kuzma C, Waqar S, Petty W, Stinchcombe T, Bradley J, Vokes E. High-Dose Once-Daily Thoracic Radiotherapy in Limited-Stage Small-Cell Lung Cancer: CALGB 30610 (Alliance)/RTOG 0538. J Clin Oncol. 2023 Jan 9:JCO2201359. doi: 10.1200/JCO.22.01359. Epub ahead of print. PMID: 36623230.

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