On May 26, 2022 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing next-generation multifunctional biotherapeutics, reported new clinical data for the HER2-targeted bispecific antibody zanidatamab in both HER2-positive breast cancer and gastric/gastroesophageal junction adenocarcinoma (Press release, Zymeworks, MAY 26, 2022, View Source [SID1234615109]). The data are being presented in two separate poster sessions at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting June 3-7, 2022 in Chicago, IL.

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"These encouraging new data sets presented at ASCO (Free ASCO Whitepaper) provide further validation of zanidatamab’s potential in the treatment of advanced HER2-positive cancers and follow the release of other promising data in gastroesophageal and breast cancer in 2021," said Neil Josephson, M.D., Chief Medical Officer at Zymeworks. "These new data continue to demonstrate the potential for zanidatamab to be an important advancement in the treatment of a wide range of HER2-expressing cancers, including in first-line treatment regimens."

The presentations detailed below are available to conference registrants on the ASCO (Free ASCO Whitepaper) conference website as well as to the general public at www.zymeworks.com/publications.

Poster Session: Zanidatamab in Combination with Chemotherapy and Tislelizumab in HER2-Positive Gastric/Gastroesophageal Junction Cancer – Clinical Results – Saturday, June 4, 08:00-11:00 am CDT

Zanidatamab, a HER2-targeted bispecific antibody, in combination with chemotherapy and tislelizumab as first-line therapy for patients with advanced HER2-positive gastric/gastroesophageal junction adenocarcinoma (G/GJEC): Preliminary results from a Phase 1b/2 study

Presenter: Keun Wook Lee, Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea

Over one million patients are diagnosed with gastric cancer every year worldwide, and it is the fourth most common cause of cancer-related deaths1. Human epidermal growth factor receptor 2 (HER2)-positive disease accounts for 15–25% of gastric cancers2. For these patients, trastuzumab in combination with chemotherapy is the global standard of care treatment but with an expected overall survival of less than 18 months, there remains a significant unmet need.

1
Globocan 2020. Available at: View Source Accessed April 2022

2
Nakamura Y, et al. Nat Rev Clin Oncol 2021;18:473–87

In 33 response-evaluable patients with advanced HER2-positive gastric/gastroesophageal junction adenocarcinoma treated with zanidatamab and tislelizumab in combination with the CAPOX chemotherapy regimen the cORR was 75.8% (25/33). The DCR was 100% (33/33) and duration of response (DOR) ranged from 2.1+ to 18.2+ months. Twenty patients (61%) remain on study at the time of data cut-off.

In addition, the data demonstrate that zanidatamab and tislelizumab in combination with the CAPOX chemotherapy is generally well tolerated, with the majority of treatment-related adverse events (TRAEs) considered mild to moderate in severity (Grade 1 or 2). The most common grade ≥ 3 TRAE was diarrhea, which was manageable in the outpatient setting; introduction of prophylactic loperamide reduced the incidence from 33% to 21%. Immune mediated adverse events occurred in 27% of patients, including ≥ Grade 3 events in 21% of patients and resulted in discontinuation of tislelizumab in 3 patients (9%). This manageable safety profile compares favorably to the current standard of care as well as to emerging treatments and is consistent with previous reports.3

This new data set further supports the launch of Zymeworks’ global Phase 3 study (HERIZON-GEA-01; NCT05152147), which is investigating zanidatamab in combination with chemotherapy with or without tislelizumab for first-line treatment of locally advanced, unresectable, or metastatic HER2-positive gastroesophageal adenocarcinoma. Zymeworks, along with its Asia-Pacific partner BeiGene, plan to enroll 714 patients at approximately 300 sites across 38 countries. Enrollment is expected to be completed by the end of 2023. The study design will be presented in a Trials in Progress poster (Poster ID: P-26) at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer taking place in Barcelona, Spain from June 29-July 2, 2022. The presentation will be available to conference registrants on the conference website as well as to the general public at www.zymeworks.com/publications at the time of presentation at the conference.

Poster Session: Zanidatamab in Combination with Docetaxel in HER2-Positive Breast Cancer – Clinical Results – Monday, June 6, 08:00-11:00 am CDT

Zanidatamab, a HER2-targeted bispecific antibody, in combination with docetaxel as first-line therapy for patients with advanced HER2-positive breast cancer: Preliminary results from a Phase 1b/2 study

Presenter: Keun Seok Lee, National Cancer Center, Center for Breast Cancer, Goyang, Republic of Korea

Worldwide, breast cancer is the most commonly diagnosed cancer and the leading cause of cancer deaths in women, with over 650,000 deaths in 20201,4. HER2-positive breast cancer accounts for approximately 20% of all breast cancers5,6,7. Though HER2-targeted agents have improved outcomes in HER2-positive breast cancer, most patients treated for advanced disease eventually relapse and develop resistant disease8,9.

In 21 response-evaluable patients with advanced HER2-positive breast cancer treated with zanidatamab and docetaxel the cORR was 90.5%, with 15 patients (78.9%) having an ongoing response at the time of the data cut. The median follow-up was 7.0 months (range 1.1-17.4 months) and the six-month progression-free survival rate was 95.2%.

3
Ku G, et al. Ann Oncol 2021;32:S1044

4
Bray F, et al. CA Cancer J Clin 2018; 68:394–424

5
Harris L, et al. J Clin Oncol 2007; 25(33)

6
Wolff AC, et al. Arch Pathol Lab Med 2007; 131(1):18–43

7
Giordano SH, et al. J Clin Oncol 2014;32(19):2078–99

8
Ayoub NM, et al. Breast Cancer 2019:11;53–69

9
Rier HN, et al. Oncologist 2017;22:901–9

The combination of zanidatamab and docetaxel had a manageable safety profile with the incidence of TRAEs consistent with standard of care therapy. The most common TRAEs were neutrophil count decreased (13 patients; 54.2%), diarrhea (13 patients; 54.2%), and anemia (nine patients; 37.5%), and the most common ≥ Grade 3 TRAEs were neutrophil count decreased (12 patients; 50.0%), diarrhea (3 patients; 12.5%), and white blood cell count decreased (2 patients; 8.3%).

"We will continue to support ongoing R&D efforts to generate and report robust data highlighting and reinforcing the potential applications of our therapeutics and technology platforms in the treatment of a wide range of diseases," said Kenneth Galbraith, Chair and CEO of Zymeworks. "We remain focused on exploring potential research and collaboration opportunities that can lead to a broader portfolio of innovative therapies for patients in need around the world with difficult-to-treat cancers."

Conference Call and Webcast

Zymeworks will host a conference call and webcast on Monday, June 6th at 4:30 pm ET to discuss the clinical data presented at ASCO (Free ASCO Whitepaper) and provide an overview on the clinical development strategy for zanidatamab. The event will be led by Kenneth Galbraith, Zymeworks’ Chair and CEO, and Neil Josephson, M.D., Zymeworks’ Chief Medical Officer. Members of Zymeworks’ executive team will be available to answer questions at the conclusion of the call.

Interested parties can access the live webcast via the Zymeworks’ website at View Source A recorded replay will be accessible after the event through the Zymeworks website.

About Zanidatamab

Zanidatamab is a bispecific antibody, based on Zymeworks’ Azymetric platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design results in multiple mechanisms of action including dual HER2 signal blockade, increased binding, and removal of HER2 protein from the cell surface, and potent effector function leading to encouraging antitumor activity in patients. Zymeworks is developing zanidatamab in multiple Phase 1, Phase 2, and pivotal clinical trials globally as a targeted treatment option for patients with solid tumors that express HER2. The FDA has granted Breakthrough Therapy designation for zanidatamab in patients with previously treated HER2 gene-amplified biliary tract cancer (BTC), and two Fast Track designations to zanidatamab, one as a single agent for refractory BTC and one in combination with standard of care chemotherapy, for first-line gastroesophageal adenocarcinoma (GEA). These designations mean zanidatamab is eligible for Accelerated Approval, Priority Review and Rolling Review, as well as intensive FDA guidance on an efficient drug development program. Zanidatamab has also received Orphan Drug designations for the treatment of biliary tract, gastric and ovarian cancers, as well as Orphan Drug designation for the treatment of gastric cancer from the European Medicines Agency.

On May 26, 2022 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that Dr. Shakeel Modak, MD from Memorial Sloan Kettering ("MSK") will present results from the naxitamab-based chemoimmunotherapy trial in patients with chemoresistant high-risk neuroblastoma ("HR-NB"), at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Annual Meeting to be held June 3-7, 2022 (Press release, Y-mAbs Therapeutics, MAY 26, 2022, View Source [SID1234615108]).

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This clinical trial studied the combination of Humanized anti-GD2 antibody naxitamab, Irinotecan, Temozolomide and Sargramostim (GM-CSF), ("HITS") protocol, and included cohort of patients that were treated at MSK in a phase 2 protocol, and at Hospital Sant Joan de Déu ("HJSD") per protocol on compassionate use basis. Health authorities have not established the safety and efficacy of the HITS protocol, as it is investigational and has not been approved by health authorities.

Eligibility criteria included evaluable or measurable chemoresistant disease. Prior anti-GD2 or irinotecan/temozolomide therapy was permitted. Each cycle, administered 3-5 weeks apart, comprised irinotecan, temozolomide, naxitamab and GM-CSF. The primary endpoint of the phase 2 trial at MSK was complete response ("CR") and partial response ("PR") after 4 cycles.

Of 90 previously heavily treated patients, (38 at MSK in the phase 2 trial, and 52 at HJSD), eight had HR-NB refractory to induction chemotherapy and 82 had up to six prior relapses.

The primary endpoint was reached in the MSK phase 2 trial: Objective Response Rate ("ORR") according to the International Neuroblastoma Response Criteria ("INRC") of 30.6 %, with a lower boundary of 20.4%. In the entire cohort, responses were 26% for CR, 11% for PR, 9% for mixed response, 27% for stable disease and 27% for progressing disease ("PD"). In the MSK phase 2 trial, the ORR was 64% for all patients, with soft tissue (48%) and skeletal MIBG uptake (66%). CR in bone marrow was seen in 57% of the patients. The ORR in patients with MYCN-amplification was 25%, in patients with refractory disease 100%, and in patients with relapsed disease 61%. Moreover, in patients who had previously received irinotecan/temozolomide or naxitamab, the ORR was 64% and 68%, respectively. In patients who had previously received dinutuximab/irinotecan/temozolomide, the ORR was 42% (five out of 12 patients).

Toxicities included myelosuppression and diarrhea as expected with irinotecan/temozolomide, pain and hypertension as expected with naxitamab, plus febrile neutropenia. No other >grade 2 unexpected toxicities occurred, and the treatment was outpatient. In this trial, human anti-human antibody did not develop in any of the 50 patients providing samples for testing.

"We are very pleased to present data for the HITS protocol," stated Thomas Gad, Founder, President and Interim CEO. "Responses in patients with relapsed or progressive high-risk neuroblastoma are challenging, as chemo-resistant disease is considered an obstacle, so we are excited to see this study met its primary endpoint. This further demonstrates the potential role for DANYELZA in HR-NB. No other GD2 antibody has been studied in such a heavily pre-treated patient population."

Researchers at Memorial Sloan Kettering Cancer Center MSK developed naxitamab, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the compound.

On May 26, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported that Marc Stapley, chief executive officer, and Rebecca Chambers, chief financial officer, will participate in two upcoming investor conferences (Press release, Veracyte, MAY 26, 2022, View Source [SID1234615107]). Veracyte will present at the William Blair 42nd Annual Growth Stock Conference on Wednesday, June 8, and will participate in a fireside chat at the Goldman Sachs 43rd Annual Global Healthcare Conference on Monday, June 13 .

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Event: William Blair 42nd Annual Growth Stock Conference
Date: Wednesday, June 8, 2022
Time: 10:40 a.m. PT / 1:40 p.m. ET

Event: Goldman Sachs 43rd Annual Global Healthcare Conference
Date: Monday, June 13, 2022
Time: 2:40 p.m. PT / 5:40 p.m. ET

Live audio webcasts of the company’s presentations will be available by visiting Veracyte’s website at View Source Replays of the webcasts will be available for 90 days following the conclusion of each live presentation broadcast.

On May 26, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported that new data from a large, population-based study reinforce the clinical utility of the Decipher Prostate genomic classifier (Press release, Veracyte, MAY 26, 2022, View Source [SID1234615106]). The findings, which will be shared for the first time at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, suggest that the Decipher Prostate tests are helping to guide prostate cancer treatment decisions and improve patient care.

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"This is the first study linking patient data from SEER, the most commonly used cancer database in the United States, and the Decipher Prostate genomic classifier, to explore the association between Decipher Prostate test results and prostate cancer treatment decisions," said Elai Davicioni, Ph.D., Veracyte’s medical director for urology and an author on the study. "The resulting data are exciting, because they demonstrate that population-based prostate cancer treatment patterns are independently associated with Decipher classifier scores."

Researchers identified 10,528 patients with a primary prostate cancer diagnosis from 2010 to 2018 in the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) database who had undergone testing with either Decipher Prostate Biopsy (n=5,015) or Decipher Prostate RP (n=5,513) between 2014 and 2020. They then evaluated the association between these patients’ Decipher scores (range 0-1) and risk groups (low, intermediate and high), and the use of active surveillance and watchful waiting (AS/WW) as well as adverse pathology at the time of radical prostatectomy (RP).

Results show that use of AS/WW was highest among those men with low risk Decipher Prostate Biopsy results (41%), as compared to men who had intermediate (32%) or high risk (17%) Decipher scores. Conversely, RP usage increased based on individuals’ Decipher test risk group (19% of low, 25% of intermediate, and 34% of high risk). Researchers observed a similar association and trend by Decipher risk group in the use of radiation therapy (13% of low, 19% of intermediate, and 29% of high Decipher risk).

"These findings provide a powerful demonstration that the Decipher Prostate genomic classifiers are giving physicians and patients valuable information to help them make important and often challenging treatment decisions. In other words, the test is positively impacting patient care, as intended," said Dr. Davicioni. "We are thrilled to be collaborating with the National Cancer Institute’s SEER program and academic researchers from leading comprehensive cancer centers and believe that these data will substantially enrich SEER’s prostate cancer registry and provide a valuable resource for oncology researchers."

About Decipher Prostate

Decipher Prostate is a 22-gene, microarray-based genomic test intended to help inform treatment decisions for men with localized prostate cancer at initial diagnosis (Decipher Prostate Biopsy) and after surgical removal of the prostate (Decipher Prostate RP). The test reports the Decipher Score, which prognosticates a patient’s risk of metastasis within five years and provides risk estimates of prostate cancer-specific outcomes. Decipher Prostate can help guide physicians to better select the appropriate therapy for a specific patient, which in turn can result in improved patient outcomes.

On May 26, 2022 Veracyte, Inc. (Nasdaq: VCYT) reported that new data from a clinical research study demonstrating the ability of its Immunoscore Immune Checkpoint (IC) assay to predict which patients with metastatic non-small cell lung cancer (NSCLC) may benefit from immune checkpoint inhibitors (ICIs) (Press release, Veracyte, MAY 26, 2022, View Source [SID1234615105]). The findings will be shared in an oral presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago on June 6 at 1:15 p.m. CDT.

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"Immune checkpoint inhibitors have revolutionized therapeutic management of patients with metastatic non-small cell lung cancer," said Jérôme Galon, Ph.D., of Inserm, the National Institute of Health and Medical Research in France, and Veracyte. "Unfortunately, current biomarkers are limited for identifying responders as only a handful of these patients benefit from ICIs. Our findings are exciting because they underscore the Immunoscore IC assay as a tool for predicting which patients may benefit from ICIs, potentially avoiding the use of costly drugs and unnecessary additional toxicity for non-responder patients."

For the study, researchers evaluated the Immunoscore IC assay in two independent cohorts totaling 265 patients who were treated with anti-PD1 or anti-PD-L1 antibodies (immune checkpoint inhibitors). The Immunoscore IC assay provided a risk score that was significantly associated with patients’ progression-free survival and overall survival. Within the two cohorts, all patients (100 percent) with a "high-risk" Immunoscore IC result relapsed in less than 18 months. In contrast, 34 percent and 33 percent of patients with a "low-risk" Immunoscore IC result did not relapse for a period of at least 36 months, in each cohort.

"These findings suggest that the Immunoscore IC assay may help biopharmaceutical companies select the right patients, helping to improve the success rate of their clinical trials, notably in combination trials including ICIs," said Corinne Danan, general manager for Veracyte’s Biopharma business unit. "Further, we believe the test’s use could help enable patients who are unlikely to respond to ICIs to enter into novel, combination-immunotherapy trials."

About Immunoscore IC

Immunoscore IC is a novel assay designed to help predict a patient’s response to immune checkpoint inhibitors. The assay measures the densities of PD-L1+ and CD8+ cells, as well as the proximity among these cells on a single tissue section using imaging tools, and then produces a risk score based on a proprietary algorithm. The Immunoscore IC assay is available as a service for biopharmaceutical companies and is part of the Immunoscore family of assays. These assays measure the immune reaction in and around the tumor and help to determine drugs’ mechanisms of action and their impact on the tumor microenvironment (TME). The Immunoscore Colon Cancer test is available clinically and analyzes T lymphocyte infiltration at the tumor site to help guide treatment decisions in localized colon cancer.