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breast cancer
immunotherapy

Sara A. Hurvitz, MD: New Findings on Neoadjuvant Trastuzumab Deruxtecan and Anastrozole in Early-Stage Breast Cancer

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).

breast cancer
immunotherapy

Sara A. Hurvitz, MD, on Updated Survival Results on T-DXd vs T-DM1 in Metastatic Breast Cancer

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).

Skin Cancer
Immunotherapy

Addition of First-Line Atezolizumab to Vemurafenib/Cobimetinib in BRAF V600–Mutant Advanced Melanoma

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 ...

Multiple Myeloma
Immunotherapy

Addition of Daratumumab to Bortezomib Plus Dexamethasone in Relapsed or Refractory Multiple Myeloma: CASTOR Trial Final Overall Survival Analysis

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...

Breast Cancer
Immunotherapy

T-DXd Yields Superior Outcomes Over Chemotherapy-Based Regimens in Patients Previously Treated With T-DM1: DESTINY-Breast02

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 ...

Breast Cancer
Immunotherapy

Neoadjuvant T-DXd Shows Clinical Activity in Patients With HER2-Low Breast Cancer

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...

Lung Cancer
Immunotherapy

Machine Learning–Based Scoring of TILs and Outcomes With Immunotherapy in Patients With NSCLC

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...

kidney cancer
immunotherapy

Sumanta Pal, MD, on Renal Cell Carcinoma: CRISPR-Engineered CAR T Cells in Advanced Disease

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).

Skin Cancer
Immunotherapy

Adjuvant Pembrolizumab May Improve Quality of Life in Patients With High-Risk Resected Melanoma

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...

Solid Tumors
Immunotherapy

Avelumab Plus Talazoparib in Patients With Advanced Solid Tumors

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 ...

Leukemia
Immunotherapy

ELIANA Trial 3-Year Update: Tisagenlecleucel in Pediatric and Young Adult Patients With Relapsed or Refractory B-Cell ALL

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...

bladder cancer
immunotherapy

Roger Li, MD, on Bladder Cancer: Boosting Immune Checkpoint Blockade With an Oncolytic Adenovirus

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).

immunotherapy

Michael B. Atkins, MD, on Reconciling Differences in Phase II and III Immuno-oncology Trial Data

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.

lung cancer
immunotherapy

Kishu Ranjan, PhD, on Non–Small Cell Lung Cancer: New Findings on a Biomarker and Immunotherapy Resistance

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).

Gastroesophageal Cancer
Gastrointestinal Cancer
Immunotherapy

T-DXd in Pretreated Patients With HER2-Low Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

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...

lung cancer
immunotherapy

Jonathan Chen, MD, PhD, on NSCLC: Predicting Response to Immunotherapy

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).

skin cancer
immunotherapy

Saman Maleki, PhD, on Melanoma: Reducing Primary Resistance to Immunotherapy

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).

breast cancer
immunotherapy

Julia Tchou, MD, PhD, on Triple-Negative Breast Cancer: Radiation Boost Plus Pembrolizumab

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).

COVID-19
Immunotherapy

Effect of Baseline Immunosuppression on COVID-19 Severity and Risk of Cytokine Storm in Patients Receiving Immunotherapy for Cancer

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,...

Lymphoma
Cost of Care
Immunotherapy

Cost-Effectiveness of Polatuzumab Vedotin-piiq Plus R-CHP and CAR T-Cell Therapy vs Standard of Care in DLBCL

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...

Leukemia
Immunotherapy

Coadministration of CD19- and CD22-Directed CAR T-Cell Therapy in Pediatric B-Cell ALL

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...

Gynecologic Cancers
Immunotherapy

Comparison of Bevacizumab Durations in Front-Line Therapy for Advanced Ovarian Cancer

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...

Leukemia
Immunotherapy

CAR T-Cell Therapy Outcomes Similar Across Different Socioeconomic Levels Among Patients With Pediatric ALL

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...

Lung Cancer
Immunotherapy

POSEIDON Trial: First-Line Durvalumab With or Without Tremelimumab Plus Chemotherapy in Metastatic NSCLC

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...

Breast Cancer
Immunotherapy

Margetuximab-cmkb vs Trastuzumab With Chemotherapy in Previously Treated Advanced HER2-Positive Breast Cancer: Final Overall Survival Analysis of the SOPHIA Trial

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...

solid tumors
immunotherapy

Antoni Ribas, MD, PhD, on Solid Tumors: Safety and Efficacy of TCR T-Cell Therapy

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).

immunotherapy

Michael A. Postow, MD, on Using the Novel Radiotracer Crefmirlimab Berdoxam for Imaging to Assess Immunotherapy Responsiveness

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).

cns cancers
immunotherapy

David Reardon, MD, on Glioblastoma: A Microbiome-Based Vaccine, Nivolumab, and Bevacizumab

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).

lung cancer
immunotherapy

Wade T. Iams, MD, on NSCLC: Combining an Antigen-Presenting Cell Activator With Pembrolizumab

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).

immunotherapy
lung cancer

Talal El Zarif, MD, and Abdul Rafeh Naqash, MD: For Patients Living With HIV and Cancer, New Data on Immune Checkpoint Inhibitors

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).

Skin Cancer
Immunotherapy

New Phase I/II Data on the CD40 Antibody Sotigalimab in Combination With Pembrolizumab in Patients With Metastatic Melanoma

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...

Skin Cancer
Immunotherapy

Management of Severe Immune-Related Adverse Events With Ipilimumab/Nivolumab and Survival in Advanced Melanoma

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...

Lung Cancer
Genomics/Genetics
Immunotherapy

First-Line Pembrolizumab vs Chemotherapy in Advanced PD-L1–Positive NSCLC Without EGFR/ALK Alterations

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...

Lung Cancer
Immunotherapy

Immune Checkpoint Inhibitors for Patients Living With HIV: Safe and Effective in Metastatic NSCLC

Immune checkpoint inhibitors are safe and effective for people living with HIV who have metastatic non–small cell lung cancer (NSCLC), according to data presented by El Zarif et al at the Society for Immunotherapy of Cancer (SITC) 2022 Annual Meeting (Abstract 437). Findings from the first matched...

Multiple Myeloma
Immunotherapy

Potential Treatment Options for Patients With Relapsed Multiple Myeloma Following CAR T-Cell Therapy

Researchers have identified potential therapies to treat patients with multiple myeloma whose cancer has relapsed following chimeric antigen receptor (CAR) T-cell therapy, according to a novel study published by Van Oekelen et al in Blood. CAR T-cell therapy has been a revolutionary treatment for...

Immunotherapy

Hormone Therapy May Lower Risk of Immune Checkpoint Inhibitor–Associated Myocarditis in Female Patients

Researchers may have discovered the underlying cause of sex differences in immune checkpoint inhibitor–associated myocarditis after immune checkpoint inhibitor treatment, according to a novel study published by Zhang et al in Science Translational Medicine. Their findings pointed to possible...

Lung Cancer
Immunotherapy

FDA Approves Tremelimumab in Combination With Durvalumab and Platinum-Based Chemotherapy for Metastatic NSCLC

On November 10, the U.S. Food and Drug Administration (FDA) approved tremelimumab (Imjudo) in combination with durvalumab (Imfinzi) and platinum-based chemotherapy for adult patients with metastatic non–small cell lung cancer (NSCLC) with no EGFR mutations or ALK genomic tumor aberrations. ...

Lymphoma
Immunotherapy

FDA Approves Brentuximab Vedotin in Combination With Chemotherapy for Pediatric Patients With Classical Hodgkin Lymphoma

On November 10, the U.S. Food and Drug Administration (FDA) approved the CD30-directed antibody-drug conjugate brentuximab vedotin (Adcetris) in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide for pediatric patients aged 2 years and older with previously...

Hepatobiliary Cancer
Immunotherapy

Expert Point of View: Robin Kate Kelley, MD

Robin Kate Kelley, MD, Professor of Clinical Medicine at the University of California, San Francisco, was invited to discuss the results of LEAP-002.1 She said the main takeaway is that lenvatinib monotherapy is active as a preferred first-line agent for fit patients who have contraindications to...

Hepatobiliary Cancer
Immunotherapy

Lenvatinib Plus Pembrolizumab in Hepatocellular Carcinoma: LEAP-002 Fails to Meet Co-primary Endpoints

The highly anticipated final analysis of the phase III LEAP-002 trial failed to meet expectations, as first-line treatment with lenvatinib plus pembrolizumab did not significantly improve outcomes in unresectable advanced hepatocellular carcinoma. Both progression-free survival and overall survival ...

Head and Neck Cancer
Immunotherapy

Expert Point of View: Glenn J. Hanna, MD, and Sherene Loi, MD, PhD

The ASCO Post asked for comment from Glenn J. Hanna, MD, Director of the Center for Salivary and Rare Head and Neck Cancers, Dana-Farber Cancer Institute, and Assistant Professor of Medicine at Harvard Medical School. Dr. Hanna said it is important to put the findings of KEYNOTE-4121 into context...

Head and Neck Cancer
Immunotherapy

KEYNOTE-412: Pembrolizumab Plus Chemoradiation Falls Short in Locally Advanced Head and Neck Cancer

Pembrolizumab plus chemoradiation failed to demonstrate a statistically significant improvement in event-free survival vs chemoradiation alone in patients with locally advanced head and neck squamous cell carcinoma, but favorable numerical trends were demonstrated, according to results of the phase ...

Breast Cancer
Immunotherapy

Expert Point of View: Shom Goel, MBBS, PhD

The invited discussant of the post hoc analysis of TROPiCS-02 was Shom Goel, MBBS, PhD, Laboratory Group Leader at the University of Melbourne and a consultant oncologist at the Peter MacCallum Cancer Centre in Australia. Dr. Goel noted there remains much to learn about the HER2-low subset of...

Breast Cancer
Immunotherapy

TROPiCS-02: Efficacy of Sacituzumab Govitecan Within HER2-Negative Subsets of Breast Cancer

In a post hoc analysis of the phase III TROPiCS-02 trial, sacituzumab govite­can-hziy improved efficacy outcomes in HER2-negative immunohistochemistry (IHC) subgroups.1 Results were consistent with those of the intent-to-treat population of hormone receptor–positive/HER2-negative advanced breast...

Lung Cancer
Immunotherapy

POSEIDON Follow-up Suggests Chemoimmunotherapy Triplet Extends Survival in Difficult-to-Treat NSCLC Mutational Subtypes

After 4 years, a limited course of five cycles of tremelimumab added to durvalumab plus chemotherapy extended overall survival in patients with metastatic non–small cell lung cancer (NSCLC) compared with chemotherapy alone, according to an updated exploratory analysis of the phase III POSEIDON...

Skin Cancer
Immunotherapy

Expert Point of View: Ignacio Melero, MD, PhD

Ignacio Melero, MD, PhD, Professor of Immunology and Co-Director of the Department of Immunology and Immunotherapy at the Clinica Universidad de Navarra in Spain, was the invited discussant of the M14TIL study. He noted that a 50% relative reduction in the risk of disease progression is impressive...

Skin Cancer
Immunotherapy

Prolonging Remission in Anti–PD-1 Refractory Melanoma With Tumor-Infiltrating Lymphocyte Therapy

For the first time in a multicenter randomized trial, T-cell therapy has been shown to improve outcomes in a solid tumor. In the phase III M14TIL trial, first-line or second-line treatment with tumor-infiltrating lymphocytes (TIL) led to a 50% reduction in disease progression or death from advanced ...

Lymphoma
Immunotherapy

ECHELON-1 Shows Benefit for First-Line Brentuximab Vedotin Plus AVD in Advanced Hodgkin Lymphoma

The results of ECHELON-1 were presented by David J. Straus, MD, of Memorial Sloan Kettering Cancer Center, New York, at the 2022 National Comprehensive Cancer Network (NCCN) Annual Congress: Hematologic Malignancies. Dr. Straus said: “It is a great honor and privilege to present updated results...

Lymphoma
Immunotherapy

High-Dose Chemotherapy and Stem Cell Transplant vs CAR T-Cell Therapy for Resistant DLBCL

Which is the preferred second-line treatment option for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL): high-dose chemotherapy and autologous stem cell transplantation (ASCT) or chimeric antigen receptor (CAR) T-cell therapy? This was the subject of a debate at the...

Lymphoma
Immunotherapy

Addition of Brentuximab Vedotin to Chemotherapy in Pediatric High-Risk Hodgkin Lymphoma

As reported in The New England Journal of Medicine by Castellino et al, the phase III Children’s Oncology Group (COG) AHOD1331 trial showed improved event-free survival with brentuximab vedotin plus chemotherapy vs standard chemotherapy in previously untreated pediatric patients with high-risk...

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