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Even as they’ve revolutionized cancer treatment, immune checkpoint inhibitors have been shown to produce a range of adverse immune-related side effects. Researchers have now identified inherited genetic variations that may place patients at high risk for complications when undergoing treatment with ...
The final results of the phase III CheckMate 651 trial showed no significant overall survival benefit with first-line nivolumab/ipilimumab vs the EXTREME regimen (cetuximab plus cisplatin or carboplatin plus fluorouracil for up to six cycles, followed by cetuximab maintenance) in recurrent or...
In a Dutch-Danish phase III trial reported in The New England Journal of Medicine, Rohaan et al found that tumor-infiltrating lymphocyte (TIL) therapy prolonged progression-free survival vs ipilimumab in patients with advanced melanoma. Study Details The open-label trial included 168 patients...
The bispecific T-cell engager molecule blinatumomab was found to improve overall survival for patients with no measurable residual disease (MRD) after initial treatment for B-lineage acute lymphoblastic leukemia (ALL), according to the phase III ECOG-ACRIN E1910 trial presented by Litzow et al at...
The chimeric antigen receptor (CAR) T-cell therapy axicabtagene ciloleucel was deemed safe and showed encouraging signs of efficacy in a small pilot trial involving patients with lymphoma of the brain and/or spinal cord, according to findings presented by Caron A. Jacobson, MD, MMSc, and colleagues ...
Jiye Liu, PhD, of Dana-Farber Cancer Institute, discusses study findings that demonstrate KDM6A regulates CD38 and CD48 expression in multiple myeloma. Dr. Liu’s team validated combination treatment with an FDA-approved EZH2 inhibitor plus daratumumab, which can overcome daratumumab resistance in preclinical multiple myeloma models, providing the rationale for combination clinical trials to improve patient outcome (Abstract 148).
Francesco Maura, MD, of the University of Miami, Sylvester Comprehensive Cancer Center, discusses his team’s findings in which they defined a comprehensive catalogue of genomic determinants of response to DKRd (carfilzomib, lenalidomide, dexamethasone) in newly diagnosed multiple myeloma. The researchers have identified a number of new genomic alterations that explain resistance to the agents currently used in combination regimens (Abstract 470).
Eileen M. Boyle, MD, PhD, of the Perlmutter Cancer Center, NYU Langone Health, discusses Fc-mediated antibody effector function, inflammation resolution, and oligoclonality and their role in predicting sustained measurable residual disease negativity in patients with newly diagnosed multiple myeloma who were treated with immunotherapy regimens. For the first time, an analysis of T-cell receptors shows that oligoclonal profiles seen on treatment may influence the fitness of the immune response (Abstract 100).
Researchers from the University of Pennsylvania’s Abramson Cancer Center presented preliminary results of an ongoing phase I clinical trial demonstrating successful retreatment with chimeric antigen receptor (CAR) T-cell therapy for patients whose cancers relapsed after previous CAR T-cell therapy. ...
Joseph Schroers-Martin, MD, of Stanford University, discusses immunogenomic features reflecting divergent biology in posttransplant lymphoproliferative disorders (PTLD). These include evidence of mismatch repair defects in Epstein-Barr virus–positive PTLD, tumor microenvironment depletion, and MYC pathway enrichment in certain patients (Abstract 72).
Eunice S. Wang, MD, of Roswell Park Comprehensive Cancer Center, discusses the outcomes of patients newly diagnosed with acute myeloid leukemia (AML) who were treated with cytarabine plus daunorubicin plus gemtuzumab ozogamicin (GO). These patients experienced higher rates of measurable residual disease–negative complete remission and complete remission with incomplete count recovery, compared to those treated with cytarabine plus idarubicin daunorubicin alone. Although adding GO was not associated with improved overall survival, longer follow-up is warranted to determine an absolute survival advantage of this regimen (Abstract 58).
The latest analysis of the TROPiCS-02 breast cancer trial shows that sacituzumab govitecan-hziy is effective in patients with a wide range of Trop-2 expression levels. The findings were reported at the 2022 San Antonio Breast Cancer Symposium by Hope S. Rugo, MD, FASCO, Professor of Medicine and...
In an early-phase trial, nearly three-quarters of patients who received talquetamab—a first-in-class, off-the-shelf, T-cell–redirecting bispecific antibody targeting both the GPRC5D and CD3 receptors—for relapsed or refractory multiple myeloma saw a significant reduction in cancer burden within a...
Tycel J. Phillips, MD, of the City of Hope National Medical Center, discusses data that showed fixed-duration glofitamab monotherapy induced high and durable complete response rates in patients with mantle cell lymphoma (MCL) who received obinutuzumab pretreatment. This is one of the largest data sets and longest follow-ups reported with a CD20/CD3 bispecific monoclonal antibody for patients with relapsed or refractory MCL (Abstract 74).
On December 9, the U.S. Food and Drug Administration (FDA) approved atezolizumab (Tecentriq) for the treatment of adult and pediatric patients aged 2 years and older with unresectable or metastatic alveolar soft-part sarcoma (ASPS). Study ML39345 Efficacy was evaluated in Study ML39345...
On November 8, 2022, cemiplimab-rwlc was approved for use in combination with platinum-based chemotherapy for first-line treatment of patients with advanced non–small cell lung cancer (NSCLC) with no EGFR, ALK, or ROS1 aberrations.1 Supporting Efficacy Data Approval was supported by findings in the ...
On September 2, 2022, durvalumab was approved for use in combination with gemcitabine/cisplatin for the treatment of patients with locally advanced or metastatic biliary tract cancer.1 Supporting Efficacy Data Approval was based on findings in the double-blind TOPAZ-1 trial (NCT03875235), in which...
Sara A. Hurvitz, MD, of the University of California, Los Angeles, Jonsson Comprehensive Cancer Center, discusses phase II results from the TRIO-US B-12 TALENT study, which showed that patients with localized, hormone receptor–positive, HER2-low breast cancer who are treated with fam-trastuzumab deruxtecan-nxki (T-DXd) in the neoadjuvant setting had an overall response rate (ORR) of 68%. When combined with anastrozole, T-DXd led to a 58% ORR. This is the first trial to evaluate T-DXd in HER2-low breast cancer, a potentially curable disease (Abstract GS2-03).
Sara A. Hurvitz, MD, of the University of California, Los Angeles, Jonsson Comprehensive Cancer Center, discusses phase III findings from the DESTINY-Breast03 study, which showed that second-line treatment with fam-trastuzumab deruxtecan-nxki (T-DXd) led to longer overall survival compared with ado-trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic breast cancer. Patients treated with T-DXd had a 36% lower risk of death than those treated with T-DM1 (Abstract GS2-02).
As reported in The Lancet Oncology by Paolo A. Ascierto, MD, and colleagues, the second interim overall survival analysis of the phase III IMspire150 trial has shown a numeric but statistically nonsignificant improvement with the addition of first-line atezolizumab to vemurafenib and cobimetinib in ...
As reported in the Journal of Clinical Oncology by Sonneveld et al, the final overall survival analysis of the phase III CASTOR trial has shown a significant overall survival benefit with daratumumab plus bortezomib/dexamethasone (D-Vd) vs bortezomib/dexamethasone alone (Vd) in patients with...
Compared with capecitabine-based regimens, fam-trastuzumab deruxtecan-nxki (T-DXd) led to higher response rates and longer survival in the third-line setting for patients with HER2-positive metastatic breast cancer previously treated with ado-trastuzumab emtansine (T-DM1), according to results from ...
Patients with localized, hormone receptor (HR)-positive, HER2-low breast cancer treated with fam-trastuzumab deruxtecan-nxki (T-DXd) in the neoadjuvant setting had an overall response rate of 75% without combining the agent with anastrozole and 63% in combination with anastrozole, according to...
In a retrospective study reported in JAMA Oncology, Rakaee et al found that tumor-infiltrating lymphocyte (TIL) levels ascertained via machine learning–based scoring on standard histologic images were associated with response in patients receiving immune checkpoint inhibitor therapy for non–small...
Sumanta Pal, MD, of the City of Hope Comprehensive Cancer Center, discusses phase I results from the COBALT-RCC study, a first-in-human clinical trial exploring CD70 CAR T-cell therapy in patients with clear cell renal cell carcinoma. The agent appeared to show an excellent safety profile with no unexpected toxicities and antitumor activity. One durable complete response is the first to be achieved with allogeneic CAR T-cell therapy in patients with relapsed or refractory solid tumors, offering proof of concept for further exploration of CD70-targeted CAR T cells in renal cell and other CD70-positive malignancies (Abstract 558).
Taken together with the primary clinical results, a secondary analysis of the phase III SWOG S1404 randomized clinical trial demonstrated that pembrolizumab provides superior clinical and patient-reported quality-of-life outcomes compared to standard of care with adjuvant ipilimumab or high-dose...
In the phase Ib/II JAVELIN PARP Medley trial reported in JAMA Oncology, Timothy A. Yap, MBBS, PhD, and colleagues found that the combination of the anti–PD-L1 agent avelumab and the poly (ADP-ribose) polymerase (PARP) inhibitor talazoparib produced objective response rates in patient subgroups with ...
As reported in the Journal of Clinical Oncology by Laetsch et al, the 3-year update of the phase II ELIANA trial showed durable responses and a manageable safety profile with tisagenlecleucel for the treatment of pediatric and young adult patients with relapsed or refractory B-cell acute...
Roger Li, MD, of the H. Lee Moffitt Cancer Center, discusses results from a phase II single-arm study of CG0070, a cancer-selective oncolytic adenovirus that creates mechanistic synergy with immune checkpoint blockade. In this trial, the virus was combined with pembrolizumab in patients with non–muscle-invasive bladder cancer that is unresponsive to bacillus Calmette-Guérin. At 3 months, 88% of the 35 patients enrolled achieved a complete response (Abstract 666).
Michael B. Atkins, MD, of Georgetown Lombardi Comprehensive Cancer Center, explores recent clinical trials in immuno-oncology in which the phase III trial produced markedly different results from the phase II trial. To help understand the potential value to patients of late-stage trials of treatment combinations, the Society for Immunotherapy of Cancer has developed a checklist for investigators, applicable to any regimen in which immune modulation is an important component of the antitumor effect.
Kishu Ranjan, PhD, of Yale University School of Medicine, discusses his study findings, which identified a deficiency in the biomarker TAP2 as a prominent immune evasion mechanism in patients whose non–small cell lung cancer has resisted immunotherapy (Abstract 148).
As reported in the Journal of Clinical Oncology by Yamaguchi et al, an exploratory cohort analysis in a Japanese/South Korean phase II trial (DESTINY-Gastric01) indicated that fam-trastuzumab deruxtecan-nxki (TDX-d) showed activity in previously treated—but anti-HER2 treatment–naive—patients with...
Jonathan Chen, MD, PhD, of Massachusetts General Hospital, discusses “immunity hubs” that interact with a reservoir of stem-like CD8 T cells and appear to be associated with subsequent response to anti–PD-1 blockade in patients with non–small cell lung cancer. Hybrid hubs, Dr. Chen says, are a favorable class of immunity hub notable for CD8-positive and TCF7-positive cells, as well as CCL19 expression (Abstract 956).
Saman Maleki, PhD, of Canada’s Western University and Lawson Health Research Institute, discusses modifying the gut microbiome in patients with advanced melanoma to induce a response to anti–PD-1 therapy and potentially reduce primary resistance to immunotherapy. A fecal microbiota transplant from healthy donors before treatment appears to be beneficial (Abstract 614).
Julia Tchou, MD, PhD, of the University of Pennsylvania, discusses preliminary results of the phase Ib/II BreastVax study, which suggested a single preoperative pembrolizumab dose plus a tumor-targeting radiation boost may result in pathologic response in patients with early-stage triple-negative breast cancer (Abstract 644).
In a registry-based retrospective cohort study reported in JAMA Oncology, Ziad Bakouny, MD, and colleagues in the COVID-19 and Cancer Consortium (CCC19 registry) found that patients receiving cancer immunotherapy who had baseline immunosuppression, but not those without baseline immunosuppression,...
In a study reported in the Journal of Clinical Oncology, Vijenthira et al found that front-line polatuzumab vedotin-piiq plus rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP), second-line chimeric antigen receptor (CAR) T-cell therapy, or the combination would not be likely to be...
In a Chinese phase II study reported in the Journal of Clinical Oncology, Wang et al found that the coadministration of CD19- and CD22-directed chimeric antigen receptor (CAR) T cells produced promising initial outcomes in pediatric patients with B-cell acute lymphoblastic leukemia (ALL) with...
In a European phase III trial (AGO-OVAR 17 BOOST/GINECO OV118/ENGOT Ov-15) reported in the Journal of Clinical Oncology, Jacobus Pfisterer, MD, PhD, and colleagues found no significant progression-free survival benefit with the extension of bevacizumab treatment from 15 to 30 months in patients...
Although socioeconomic status often influences survival outcomes, pediatric patients with relapsed or refractory acute lymphoblastic leukemia (ALL) who were living in poverty and were treated with CAR T-cell therapy achieved similar overall survival and were equally likely to achieve a complete...
As reported in the Journal of Clinical Oncology by Melissa L. Johnson, MD, and colleagues, the pivotal phase III POSEIDON trial has shown significantly improved progression-free and overall survival with the addition of tremelimumab and durvalumab to platinum-based chemotherapy in the first-line...
As reported in the Journal of Clinical Oncology by Hope S. Rugo, MD, FASCO, and colleagues, the final overall survival results of the pivotal phase III SOPHIA trial have shown no significant difference between margetuximab-cmkb plus chemotherapy vs trastuzumab plus chemotherapy in previously...
Antoni Ribas, MD, PhD, of the University of California, Los Angeles, discusses a phase I study that used CRISPR gene editing to simultaneously “knock out” endogenous T-cell receptors and replace them with personalized neoantigen T-cell receptors in patients with solid tumors. The edited TCR T-cell products were safely infused and trafficked to the tumor lesions (Abstract 1478).
Michael A. Postow, MD, of Memorial Sloan Kettering Cancer Center, discusses new findings on the correlation between CD8 cell PET imaging with zirconium-89–crefmirlimab berdoxam and CD8 cell immunohistochemistry in patients with advanced cancer receiving immunotherapy. Noninvasive CD8 PET scanning with crefmirlimab berdoxam permits whole-patient, longitudinal CD8 assessment, which is currently under investigation as a biomarker for immunotherapy responsiveness and may be a useful tool for immunotherapy development and clinical management (Abstract 1472).
David Reardon, MD, of Dana-Farber Cancer Institute, discusses phase I/II results from the EOGBM1-18/ROSALIE study, which showed the EO2401 vaccine plus nivolumab generated systemic immune responses correlating with efficacy in patients with recurrent glioblastoma. Adding bevacizumab to this combination appeared to improve efficacy. (Abstract 642).
Wade T. Iams, MD, of Vanderbilt University Medical Center, discusses phase II efficacy results from the first-line non–small cell lung cancer cohort of the TACTI-002 study. The results suggest that when combined with pembrolizumab, eftilagimod alpha yielded encouraging efficacy across all PD-L1 levels, including patients with PD-L1 low and PD-L1 negative disease (Abstract 1470).
Talal El Zarif, MD, of Dana-Farber Cancer Institute, and Abdul Rafeh Naqash, MD, of Stephenson Cancer Center at The University of Oklahoma, discuss the results of their cohort study of patients living with HIV and metastatic non–small cell lung cancer, who are often underrepresented in clinical trials, and the safety and efficacy of treating this unique population with immune checkpoint inhibitors (ICIs). The data showed that patients living with HIV and lung cancer had similar toxicity profiles and clinical outcomes as did those who did not have HIV and received ICIs (Abstract 437).
New data from an ongoing phase II trial evaluating first-line intratumoral administration of sotigalimab, a CD40 agonist antibody, in combination with systemic pembrolizumab, an anti–PD-1 antibody, in metastatic melanoma was presented by Bentebibel et al at the Society for Immunotherapy of Cancer...
In a Dutch study reported in JAMA Oncology, van Not et al found that management of grade ≥ 3 immune-related adverse events with steroids alone vs steroids plus second-line immunosuppressants was associated with better survival outcomes among patients receiving first-line combination ipilimumab and...
As reported in the Journal of Clinical Oncology by Gilberto de Castro, Jr, MD, PhD, and colleagues, 5-year follow-up of the KEYNOTE-042 trial showed a maintained overall survival benefit with first-line pembrolizumab vs chemotherapy in patients with non–small cell lung cancer (NSCLC) with a PD-L1...