On June 4, 2023 Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit," "we," or the "Company") reported promising data for its novel, potential first-in-class investigational bispecific antibody, ivonescimab, that is being presented today from 8:00 to 11:00am at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL (Press release, Summit Therapeutics, JUN 4, 2023, View Source [SID1234632441]).

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AK112-201 (NCT04736823) is an open-label Phase II study evaluating ivonescimab plus chemotherapy for 174 patents across three cohorts of patients. The poster features data from 135 patients in Cohort 1 of this study: patients who are treatment-naïve with advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors do not have actionable genomic alterations (i.e., patients’ tumors do not have actionable mutations in endothelial growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK)).

Notably, this Phase II data set summarizes results to date from 63 patients with squamous histology. These patients experienced a median progression-free survival (PFS) of 11.0 months (95% CI: 9.5 to 16.8 months) and an overall response rate (ORR) of 67% (95% CI: 53% to 78%). After a median follow-up time of 13.3 months, median overall survival (OS) was not reached; although, estimated 9-month OS was 93.2%. The frequency of Grade ≥3 treatment-related adverse events (TRAEs) was 41%. The most frequent treatment-emergent adverse events were anemia, decreased neutrophil counts, and alopecia.

Summit has begun clinical development activities on the Phase III HARMONi-3 study, which intends to evaluate ivonescimab combined with chemotherapy in first-line metastatic squamous NSCLC patients. Summit intends to treat patients in the HARMONi-3 trial during the second half of 2023.

The poster is being presented by Dr. Li Zhang, Sun Yat-Sen University Cancer Center,1 with data generated and analyzed by our collaboration and licensing partner, Akeso, Inc. (HKEX Code: 9926.HK).

In addition to the patients with squamous histology described above, Cohort 1 includes updated data from 72 patients with non-squamous histology. Median PFS experienced by these patients was 12.3 months (95% CI: 8.3 to 19.3 months) and median overall survival was not reached after 13.3 months of median follow-up time. The frequency of Grade ≥3 TRAEs was 19%. The most frequent treatment-emergent adverse events were anemia, decreased neutrophil counts and constipation.

The poster also contains brief updates related to the two other cohorts in this trial:

Cohort 2: Advanced or metastatic non-squamous EGFR-mutated NSCLC patients whose tumor has progressed following treatment with an EGFR-TKI
Cohort 3: Advanced or metastatic NSCLC patients whose tumor has progressed following PD-(L)1 therapy combined with doublet-platinum chemotherapy.
Of the 19 patients in Cohort 2, median PFS of 8.5 months was experienced; median overall survival was not reached. The ORR for patients in this cohort was 68% and the median duration of response (DOR) was 8.5 months. Approximately 32% of patients in this cohort remained on treatment at 12 months.

There were 20 patients in Cohort 3; these patients experienced a median PFS of 7.1 months and median OS was 15.6 months. The ORR for patients in this cohort was 40% and the median DOR was 12.4 months. Approximately 35% of patients in this cohort remained on treatment at 12 months.

Ivonescimab had an acceptable safety profile in combination with platinum-doublet chemotherapy for patients with advanced or metastatic NSCLC who had progressed following an EGFR-TKI, as well as in combination with chemotherapy for patients who had progressed following treatment with a PD-(L)1 inhibitor plus platinum-doublet chemotherapy in this clinical study.

In May 2023, the first patient was treated in Summit’s license territories in the Phase III HARMONi clinical trial. HARMONi intends to evaluate ivonescimab combined with chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who have progressed after treatment with a third-generation EGFR tyrosine kinase inhibitor (TKI) (AK112-301, NCT05184712).

Ivonescimab, known as SMT112 in the United States, Canada, Europe, and Japan, and as AK112 in China and Australia, is a novel, potential first-in-class investigational bispecific antibody combining the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects associated with blocking VEGF into a single molecule. There is higher expression (presence) of both PD-1 and VEGF in tumor tissue and the tumor microenvironment (TME) as compared to normal, healthy tissue in the body. Ivonescimab’s tetravalent structure (four binding sites) enables higher avidity (accumulated strength of multiple binding interactions) with over 10 fold increased binding affinity to PD-1 in the presence of VEGF in vitro in tumor cells.2 This tetravalent structure, the intentional design of the molecule, and bringing these two targets into a single bispecific antibody have the potential to steer ivonescimab to the tumor tissue versus healthy tissue, which is intended to improve side effects and safety concerns associated with these targets and has the potential to focus the antitumor activity of both targets. Over 750 patients have been treated with ivonescimab across multiple clinical studies in different indications in China and Australia.

Lung cancer is believed to impact approximately 238,0003 people in the United States each year and approximately 477,0004 in Europe. NSCLC is the most prevalent type of lung cancer and represents approximately 80% to 85% of all incidences.5 Among patients with non-squamous NSCLC, approximately 15% have EGFR-sensitizing mutations in the United States and Europe.6 Patients with squamous histology represent approximately 25% to 30% of NSCLC patients.7

About the ASCO (Free ASCO Whitepaper) Poster

Poster Title: Phase II results of Ivonescimab (AK112/SMT112) a novel PD-1/VEGF bispecific in combination with chemotherapy for first line treatment of advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations (AGA) in EGFR/ALK

ASCO Poster Board Number: 75

ASCO Abstract No.: 9087

ASCO Poster Session: Lung Cancer – Non-Small Cell Metastatic Poster Session.

Session Date & Time: Sunday June 4, 8:00 to 11:00am CT

On June 4, 2023 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported the presentation of biomarker findings from a Phase II study of alisertib plus paclitaxel versus paclitaxel alone (Clinicatrials.gov identifier NCT02187991) in metastatic hormone receptor positive (HR+) and triple negative (TN) breast cancer at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting held June 2-6 in Chicago and online (Press release, Puma Biotechnology, JUN 4, 2023, View Source [SID1234632440]). The Phase II trial was conducted through The US Oncology Network. The results of this trial were published by Joyce O’Shaughnessy et al. (Jama Network Open, April 2021) and showed that the addition of alisertib to paclitaxel improved progression-free survival (PFS) among enrolled patients compared with paclitaxel alone (HR, 0.56; 95%CI, 0.37-0.84; P = .005).

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The poster (Abstract #1037, poster #258), entitled, "Association of C-MYC, MYC target gene, and unfolded protein response (UPR) expression with clinical benefit from the oral aurora kinase A (AURKA) inhibitor, alisertib (A), in combination with paclitaxel (P) compared with P alone in patients (Pts) with HER2-negative metastatic breast cancer (MBC)," was presented at the Breast Cancer – Metastatic Poster Session by Sara A. Byron, Ph.D., Integrated Cancer Genomics Division, Translational Genomics Research Institute (TGen), part of City of Hope, on June 4 at 8:00 a.m. CDT. A copy of the poster is available on the Puma Biotechnology website.

Archival tissue samples from patients enrolled in the clinical study were analyzed at TGen. Of the 140 patients enrolled in the trial, 45 from the alisertib plus paclitaxel arm and 51 from the paclitaxel arm had sufficient tissue available for next generation sequencing, and 31 from the alisertib plus paclitaxel arm and 35 from the paclitaxel arm had enough for RNA sequencing/gene set enrichment analysis. The most frequently mutated genes were PIK3CA (45%) and TP53 (44%). No mutations were significantly associated with response or resistance to alisertib plus paclitaxel, including those in PIK3CA, TP53, AKT1, HER2, and CDH1.

Increased MYC RNA expression was observed in tumors from patients who did not derive clinical benefit from paclitaxel alone (defined as PFS less than 6 months) compared to those with benefit from paclitaxel alone (defined as PFS greater than or equal to 6 months). Increased MYC RNA expression was not observed in patients who did not appear to benefit from alisertib plus paclitaxel. Elevated expression of genes involved in MYC activation and in unfolded protein response (a pro-survival mechanism) were enriched in alisertib plus paclitaxel responders compared to paclitaxel responders and were associated with poor response to paclitaxel alone. In 12 patients with exceptional response to alisertib plus paclitaxel (defined as PFS greater than or equal to 12 months), increased expression of genes involved in MYC activation and in epithelial to mesenchymal transition (a hallmark of cancer progression and metastasis) was observed in comparison to cancers from patients whose disease progressed within 6 months of initiating alisertib + paclitaxel (n=11) or those with exceptional response to paclitaxel alone (n=4).

"There continues to be a need for new drugs for the treatment of metastatic ER-positive, HER2-negative breast cancer and triple negative breast cancer," said Joyce A. O’Shaughnessy, M.D., the Celebrating Women Chair in Breast Cancer Research at Baylor University Medical Center, Texas Oncology, and Chair of Breast Cancer Research for the US Oncology Network in Dallas, Texas. "The results of this study and the subsequent biomarker analysis demonstrate that the addition of alisertib to paclitaxel may help to identify which patients are likely to derive the most benefit from alisertib and helps to identify biomarker focused populations that can be studied in future clinical trials of alisertib."

Sara Byron, Ph.D., Research Associate Professor in the Integrated Cancer Genomics Division at TGen, added, "We are pleased to have collaborated with Dr. O’ Shaughnessy on evaluating the effect of alisertib in this breast cancer trial. The biomarkers that were associated with clinical benefit to alisertib appeared to be the ones associated with an aurora kinase A inhibitor like alisertib, and we are hopeful that this work will help identify future patient populations that may benefit from alisertib."

Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology, said, "We are very pleased with the results of this biomarker analysis. We are committed to and focused on the development of alisertib in biomarker defined populations who may derive the greatest benefit from treatment with alisertib. This biomarker analysis will be very helpful to the design of the future trials of alisertib that we are planning in hormone receptor positive HER2-negative breast cancer."

On June 4, 2023 VITRAC Therapeutics, LLC (VITRAC) reported a poster on the Phase 1a/1b clinical trial of aurora kinase A (AURKA) inhibitor, VIC-1911, as monotherapy and in combination with KRAS G12C inhibitor, sotorasib (Press release, VITRAC Therapeutics, JUN 4, 2023, View Source [SID1234632439]). The study targets the treatment of KRAS G12C-mutant non-small cell lung cancer (NSCLC). The findings were presented at the prestigious 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago on June 4.

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The clinical investigators involved in the study include S. B. Goldberg, MD, MPH, Principal Investigator (PI) and Study Chair at Yale Cancer Center, S. R. Punekar, MD, PI, NYU Langone-Laura and Isaac Perlmutter Cancer Center, V. Velcheti, MD, PI, New York University Perlmutter Cancer Center, J. W. Riess, MD, PI, University of California Davis Comprehensive Cancer Center, K. A. Scilla, MD, PI, University of Maryland Cancer Center, J. W. Carlisle, MD, PI, Emory University Winship Cancer Center, K. Politi, PhD, J.W. Lee, PhD, and B. Burtness, MD, Yale School of Medicine and Yale Cancer Center, T. Myers, MD, and L. Paradiso, DVM, Vitrac Therapeutics.

VIC-1911 is a highly selective, orally administered small molecule inhibitor of AURKA. Overexpression of the AURKA is found in multiple tumors, including NSCLC. New treatment approaches are urgently needed to mitigate and overcome resistance to KRAS G12C inhibitors.

Preclinical studies indicate that AURKA could play a role in resistance to KRAS G12C inhibitors. VIC-1911, both as monotherapy and in combination with a KRAS G12C inhibitors sotorasib and adagrasib, has shown effectiveness against NSCLC with intrinsic and acquired resistance to KRAS G12C inhibitors in preclinical models. These findings suggest the potential of VIC-1911, both as a monotherapy and in combination with sotorasib, for patients with KRASG12C-mutated NSCLC.

"We now have two approved KRAS G12C inhibitors, sotorasib and adagrasib, to treat patients with KRAS G12C-mutated NSCLC," stated Sarah Goldberg, MD, Study Chair. "Despite the satisfactory response rates in patients naïve to KRAS G12C inhibitor therapy, over 50% of patients exhibit primary resistance. Moreover, many patients who do respond soon develop acquired resistance and relapse. With this innovative approach combining AURKA and KRAS G12C inhibitors, we aim to enhance therapeutic outcomes for our patients with KRAS G12C-mutant NSCLC."

"VIC-1911 is a potent, selective AURKA inhibitor. The supporting preclinical studies strongly advocate for the combination of AURKA inhibition with VIC-1911 and KRAS G12C inhibitors in KRAS G12C-mutant NSCLC," said Thomas Myers, MD, Chief Medical Officer at VITRAC. "Through this multi-targeted approach, we hope to deliver more effective therapeutic outcomes for patients with KRAS G12C-mutant NSCLC

On June 4, 2023 Servier, a leader in oncology committed to bringing innovative therapies to the patients we serve, today presented results from the pivotal Phase 3 INDIGO clinical trial investigating vorasidenib, an investigational, oral, selective, highly brain-penetrant dual inhibitor of mutant IDH1/2 enzymes in patients with residual or recurrent isocitrate dehydrogenase 1 or 2 (IDH1/2) mutant low-grade glioma who have been treated with surgery only (Press release, Servier, JUN 4, 2023, View Source [SID1234632436]). INDIGO succeeded in meeting its primary endpoint of progression free survival (PFS) per blinded independent review committee (BIRC) and key secondary endpoint of time to next intervention (TTNI) at the prespecified second interim analysis. The data were presented as a late breaking abstract during the plenary session at the 2023 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), and simultaneously published in the New England Journal of Medicine.

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The primary endpoint, PFS per BIRC, was statistically significant and clinically meaningful in favor of the vorasidenib arm (HR, 0.39; 95% CI, 0.27 to 0.56; 1-sided P=0.000000067), median PFS for vorasidenib and placebo was 27.7 vs 11.1 months, respectively. TTNI was also statistically significant (HR, 0.26; 95% CI, 0.15 to 0.43; 1-sided P=0.000000019). Median TTNI was not reached for vorasidenib and 17.8 months for placebo.

"Grade 2 gliomas are progressive, malignant brain tumors with a poor prognosis, and the current treatment paradigm, which can be associated with short- and long-term toxicities, has not seen progress in more than two decades," said Ingo K. Mellinghoff, M.D., Chair, Department of Neurology, Memorial Sloan Kettering Cancer Center. "For patients living with IDH mutant low-grade glioma, as determined by molecular testing, treatment with a targeted therapy such as vorasidenib has the potential to provide transformative benefits."

"The overwhelmingly positive INDIGO results convincingly demonstrate the impact of targeting IDH mutations early in cancer biology where a monotherapy approach can lead to a profoundly meaningful outcome for patients with recurrent or residual IDH-mutant grade 2 gliomas," said Susan Pandya, M.D., Vice President Clinical Development and Head of Cancer Metabolism Global Development Oncology & Immuno-Oncology, Servier. "IDH mutations are disease defining alterations in IDH-mutant diffuse gliomas and these pivotal data coupled with vorasidenib’s especially high penetration of the blood-brain barrier, offer opportunities to evolve the treatment landscape for patients living with this malignancy. We look forward to working with the FDA on its review of vorasidenib as a potential therapy in IDH-mutant diffuse glioma."

INDIGO is a registration-enabling Phase 3 global, randomized, double-blinded placebo-controlled study of vorasidenib in patients with residual or recurrent grade 2 glioma with an isocitrate dehydrogenase 1/2 (IDH1/2) mutation who have undergone surgery as their only treatment. IDH1/2 mutations occur in approximately 80% and 4% of grade 2 gliomas, respectively.

As of September 6, 2022 (2nd planned interim analysis data cutoff), 331 patients were randomized globally to receive vorasidenib (n=168) 40 mg daily or placebo (n=163) continuously in 28-day cycles. Of the 331 patients, 172 had oligodendroglioma (88 vorasidenib; 84 placebo) and 159 patients had astrocytoma (80 vorasidenib; 79 placebo). Median time from the last surgery until randomization was 2.5 years on the vorasidenib arm vs 2.2 years on the placebo arm.

The safety profile for vorasidenib was well tolerated and consistent with Phase 1 results. The most common Grade ≥3 adverse events for patients receiving vorasidenib vs placebo were alanine aminotransferase increased (9.6% vs 0), aspartate aminotransferase increased (4.2% vs 0) and seizure (4.2% vs 2.5%).

Vorasidenib was granted fast track designation by the U.S. Food & Drug Administration (FDA) in March 2023. Servier is working to determine timelines for submission of a New Drug Application (NDA) for vorasidenib to the FDA.

"Patients with brain cancer live with the constant fear of what their future looks like. For over twenty years, the lack of new treatment options has put patients in a position of making the difficult decision to accept a treatment that has significant side effects or to preserve cognitive function for as long as possible," said Brock Greene, Founder of Oligo Nation, a leading brain cancer patient organization. "Servier’s positive clinical trial data for a targeted therapy in IDH-mutant glioma that may possibly improve outcomes for patients provides this community with new hope that they have been waiting decades for."

About the INDIGO Phase 3 Trial

INDIGO is a registration-enabling Phase 3 global, randomized, double-blinded placebo-controlled study of vorasidenib in patients with residual or recurrent grade 2 glioma with an isocitrate dehydrogenase 1/2 (IDH1/2) mutation who have undergone surgery as their only treatment. (NCT04164901).

About Glioma1

Gliomas are tumors that arise from glial or precursor cells within the central nervous system (CNS). The 2021 WHO classification recognizes four general groups of gliomas, one of which is adult-type diffuse gliomas. These diffuse gliomas are the most common primary malignant brain tumors in adults. The pathogenesis and prognosis of these tumors are tightly linked to mutations (or lack thereof) in the metabolic enzyme isocitrate dehydrogenase (IDH), and molecular testing is required for proper diagnosis. As of 2021, adult-type diffuse gliomas are sub-divided into only three categories:

Astrocytoma, IDH-mutant (CNS WHO grades 2-4)
Oligodendroglioma, IDH-mutant and1p19q-codeleted (CNS WHO grades 2-3)
Glioblastoma, IDH-wildtype (CNS WHO grade 4)

On June 4, 2023 A Phase 3 trial has reported that patients with advanced Stage (3 or 4) classic Hodgkin lymphoma who underwent initial treatment with nivolumab, a PD-1 checkpoint inhibitor, and AVD chemotherapy (N-AVD) had a significantly lower risk of their cancer getting worse than patients treated with brentuximab vedotin, a monoclonal antibody, and AVD (BV-AVD) a year after starting treatment (Press release, City of Hope, JUN 4, 2023, View Source [SID1234632437]).

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Ninety-four percent of adolescent and adult patients in the N-AVD group had progression-free survival compared with 86% in the BV-AVD arm. N-AVD was also well-tolerated as there were few serious immune-related side effects in the S1826 trial. The median follow-up was 12.1 months.

SWOG Cancer Research Network trial, led by City of Hope researcher, shows potential new therapy for a lymphoma

These late-breaking findings will be presented by City of Hope’s Alex Herrera, M.D., at ASCO (Free ASCO Whitepaper)’s 2023 Plenary Session, June 4, at 2:53 p.m. CT in Hall B1 and will be featured in the official ASCO (Free ASCO Whitepaper) press program.

Lead investigator on the study, Herrera is chief of the Division of Lymphoma at City of Hope, one of the largest cancer research and treatment organizations in the United States, and is an investigator with the SWOG Cancer Research Network, a clinical trials group funded by the National Cancer Institute (NCI), part of the National Institutes of Health.

"The results are remarkable. The combination of nivolumab and chemotherapy is potent and safe in patients with Stage 3 or 4 classic Hodgkin lymphoma as an initial treatment," said Herrera, "The therapy is poised to be a standard for treatment of advanced Hodgkin lymphoma. This is indeed great news for patients with this cancer as there is another effective and safe treatment option for them."

Georgie Garabet, 43, of Glendora, California, was one of the patients who participated in the trial. When Garabet began to feel sick in early 2020, he was a 40-year-old father of two children under the age of 3. His symptoms included uncontrollable itching all over his body and severe weight loss. After a few trips to emergency rooms and to his primary care doctor, he was eventually diagnosed with Stage 3 Hodgkin lymphoma.

"I panicked when I heard the word cancer," Garabet said. At the same time, he was relieved to know what was causing his symptoms.

Garabet met Herrera and instantly felt he was in good hands. "He explained everything so well," he added. Garabet enrolled in the trial. After his first infusion, he felt exhausted but that was the worst he felt during treatment. After only four infusions, he was in remission. He was advised to continue the treatment in case any cancer lingered, and he did. "Now when people tell me they have cancer, I tell them not to panic. There are a lot of cures now," he added.

The S1826 trial, supported by the NCI and led by SWOG, is the largest classic Hodgkin lymphoma study ever conducted in the NCI’s National Clinical Trials Network and is also representative of a diverse patient population. About a quarter of the enrolled patients were Black or Hispanic. A partnership with the Children’s Oncology Group (COG) helped ensure the trial included young adolescents, and a quarter of enrolled patients were younger than 18 years old. Nearly two-thirds of all patients had Stage 4 cancer.

"This study speaks to the power of the National Clinical Trials Network and is an excellent example of the transformative work that the NCI funds," said Jonathan Friedberg, M.S., M.M.Sc., senior author of the study, chair of the SWOG Cancer Research Network’s lymphoma committee and director of the Wilmot Cancer Institute at the University of Rochester. "Hodgkin lymphoma is not a common disease and the NCTN enabled a large network of more than 200 pediatric and adult community providers and academic medical centers to work together. Because of that, we were able to get data very quickly and directly impact patient care. This was a critical investment in cancer research and treatment."

Patients with Stage 3 or 4 classic Hodgkin lymphoma who had not been previously treated and were age 12 or older were eligible for the trial. Of a total of 976 eligible patients, 489 were enrolled in the N-AVD arm (nivolumab plus Adriamycin, vinblastine and dacarbazine), while 487 were part of the BV-AVD group. Each group received six infusion cycles of each combination therapy.

As expected with combination chemotherapy, the most common side effects included gastrointestinal and hematologic toxicities, and fatigue. However, less than 1% of patients needed radiation after trial treatment, which is a dramatic reduction in the proportion of patients being initially treated for Hodgkin lymphoma who need radiation, especially among pediatric patients.

"The ability to maintain high rates of relapse-free survival with minimal use of radiation therapy in children with newly diagnosed advanced stage Hodgkin lymphoma will be a paradigm shift," said Sharon Castellino, M.D., M.Sc., chair of the COG Hodgkin lymphoma committee and director of the Leukemia and Lymphoma Program at the Aflac Cancer and Blood Disorders Center, Children’s Healthcare of Atlanta, Winship Cancer Institute at Emory University.

Brentuximab vedotin was the first antibody-drug conjugate developed for classic Hodgkin lymphoma. Several studies have demonstrated that incorporating the therapy into frontline treatment improves progression-free survival and overall survival. Despite improved outcomes, there are still serious side effects; relapses can occur.

"There is definitely a need to improve frontline therapies for Hodgkin lymphoma, particularly because a disproportionate number of patients with this disease are teens and young adults," Herrera added.

PD-1 checkpoint inhibitors are a powerful and growing form of immunotherapy used to treat melanoma, kidney cancer, head and neck cancers, relapsed or difficult to treat Hodgkin lymphoma and other cancers. The PD-L1 protein is expressed on Hodgkin lymphoma tumor cells and aids the cancer by signaling to immune cells, such as T cells, to stop working against tumors.

Checkpoint inhibitors block the PD-L1 protein to help the immune system and, specifically, T cells, do what they’re designed to do, eradicate cancer. In this study, adding nivolumab to chemotherapy worked so well that some patients experienced remission after only a few treatments.

Next steps for the trial include following patients to measure the durability of progression-free survival, overall survival and other patient outcomes.

Funding was provided by: National Cancer Institute of the National Institutes of Health U10CA180888, U10CA180819, U10CA180820, U10CA180821, U10CA180863, U10CA180886 and Bristol-Myers Squibb through a Cooperative Research and Development Agreement between the NCI and BMS. Brentuximab vedotin was provided by Seagen.

In addition to Herrera and Friedberg, co-authors on the presentation include Michael L. LeBlanc, Ph.D., SWOG Statistical Center and Fred Hutchinson Cancer Center; Sharon M. Castellino, M.D., M.Sc., Emory University, Aflac Cancer and Blood Disorders Center, Children’s Healthcare of Atlanta; Hongli Li, M.S., SWOG Statistical Center and Fred Hutchinson Cancer Center; Sarah C. Rutherford, M.D., Weill Cornell Medicine-New York Presbyterian Hospital; Andrew M Evens, D.O., M.Sc., Rutgers Cancer Institute of New Jersey; Kelly Davison, M.D., McGill University; Angela Punnett, M.D., Hospital for Sick Children, Toronto; David C. Hodgson, M.D., M.P.H., Department of Radiation Oncology, Princess Margaret Cancer Centre, University Health Network; Susan K Parsons, M.D., M.R.P., Tufts Medical Center, Tufts University School of Medicine; Sairah Ahmed, M.D., University of Texas MD Anderson Cancer Center; Carla Casulo, M.D., Division of Hematology/Oncology, University of Rochester; Nancy L. Bartlett, M.D., Washington University School of Medicine in St. Louis; Joo Y. Song, M.D., Department of Pathology, City of Hope; Richard F. Little, M.D., Cancer Therapy Evaluation Program, National Cancer Institute; Brad S. Kahl, M.D., Washington University School of Medicine in St. Louis; John P. Leonard, M.D., Weill Cornell Medicine-New York Presbyterian Hospital; Sonali M. Smith, M.D., Department of Oncology, University of Chicago; and Kara M. Kelly, M.D., Department of Pediatric Oncology, Roswell Park Comprehensive Cancer Center.