On June 3, 2021 Novartis reported that results of the Phase III VISION study evaluating 177Lu-PSMA-617, a targeted radioligand therapy, plus best standard of care (SOC) demonstrated significant improvement in overall survival (OS) compared to SOC alone, in patients with progressive PSMA-positive metastatic castration-resistant prostate cancer (mCRPC)1 (Press release, Novartis, JUN 3, 2021, View Source [SID1234583443]). The difference in OS between study arms was statistically significant (one-sided p<0.001), with an estimated 38% reduction in risk of death in the 177Lu-PSMA-617 arm (n=551) compared to the best standard of care only arm (n=280) (hazard ratio: 0.62 with 95% confidence interval (CI): (0.52, 0.74))1. These results will be presented during the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting plenary session on June 6.

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Patients receiving 177Lu-PSMA-617 also demonstrated a statistically significant (one-sided p<0.001) 60% risk reduction for radiographic progression-free survival or death (rPFS), compared to the best standard of care only arm (hazard ratio: 0.40 with 99.2% CI: (0.29 0.57))1. There was a higher rate of drug-related treatment emergent adverse events reported in the 177Lu-PSMA-617 treatment arm (85.3%) compared to standard of care alone (28.8%)1.

Across both arms of the study, rates of treatment discontinuation associated with treatment-emergent adverse events occurred as follows: In the 177Lu-PSMA-617 plus standard of care (SOC) arm, 11.9% of patients discontinued 177Lu-PSMA-617 and 8.5% discontinued SOC; while in the SOC alone arm 7.8% of patients discontinued treatment1.

"Patients suffering from metastatic CRPC who have progressed through contemporary hormonal treatments and chemotherapy have few meaningful therapeutic options," said Michael J. Morris, MD, who chaired the study’s Scientific Committee and is the Prostate Cancer Section Head, Genitourinary Oncology Service, Division of Solid Tumor Oncology at Memorial Sloan Kettering Cancer Center. "The study demonstrated that 177Lu-PSMA-617 improves disease progression and prolongs survival, which are key measures of clinical benefit in the mCRPC population. I am grateful to be a part of this study that may lead to additional therapeutic options for these patients."

"Men with metastatic prostate cancer have an approximately 3 in 10 chance of surviving 5 years2. These data from the first Phase III study of a radioligand therapy in this advanced prostate cancer setting confirm the potential of 177Lu-PSMA-617 targeted therapy to improve clinical outcomes," said John Tsai, Head of Global Drug Development and Chief Medical Officer for Novartis. "Our comprehensive development program for this targeted therapy seeks to reach eligible patients with advanced prostate cancer, who express the PSMA biomarker1,3-6. And, we won’t stop with prostate cancer, our team is exploring next generation RLT across a number of tumor types."

Two additional studies with 177Lu-PSMA-617 radioligand therapy in earlier lines of treatment for metastatic prostate cancer are planned to start in the first half of 2021, investigating potential clinical utility in the mCRPC pre-taxane setting (PSMAfore) and in the metastatic hormone-sensitive setting (PSMAddition).

Additional VISION data
Median OS (95% CI) for the 177Lu-PSMA-617 plus best standard of care arm in the VISION study was 15.3 months (14.2, 16.9), compared to 11.3 months (9.8, 13.5) in the best standard of care arm only1. The median rPFS (99.2% CI) was 8.7 months (7.9, 10.8) for the 177Lu-PSMA-617 arm compared to 3.4 months (2.4, 4.0) for the best standard of care only arm1.

Key secondary endpoints were also met. The median time to first symptomatic skeletal event was 11.5 months (95% CI: 10.3, 13.2) in 177Lu-PSMA-617 arm compared to 6.8 months (95% CI: 5.2, 8.5) in the best standard of care only arm (hazard ratio: 0.50 (95%CI: 0.40, 0.62)); two-sided p-value: <0.0011. Significant differences were also seen in overall response rate in patients with measurable or non-measurable disease at baseline (29.8% partial or complete response in the 177Lu-PSMA-617 arm compared to 1.7% partial response in the best standard of care only arm (two-sided p-value: <0.001)) and disease control rate (89.0% in 177Lu-PSMA-617 arm compared to 66.7% in the best standard of care only arm (two-sided p-value: <0.001))1.

Grade ≥3 drug-related treatment emergent adverse events occurred in 28.4% of the 177Lu-PSMA-617 arm compared to 3.9% in the best standard of care only arm1. The most common treatment emergent adverse events regardless of drug relatedness (above 2% respectively for the 177Lu-PSMA-617 and best standard of care arm) were anemia (12.9% vs. 4.9%), thrombocytopenia (7.9% vs. 1%), lymphopenia (7.8% vs. 0.5%), fatigue (5.9% vs. 1.5%), urinary tract infection (3.8% vs 0.5%), neutropenia (3.4% vs 0.5%), hypertension (3.2% vs 1.5%), back pain (3.2% vs. 3.4%), acute kidney injury (3.0% vs 2.4%), leukopenia (2.5% vs. 0.5%), bone pain (2.5% vs. 2.4%), hematuria (2.5% vs 0.5%), and spinal cord compression (1.3% vs. 5.4%)1.

Serious drug-related treatment emergent adverse events occurred in 9.3% of patients in the 177Lu-PSMA-617 arm compared to 2.4% in the best standard of care only arm1.

Visit View Source for the latest information from Novartis, including our commitment to the Oncology community, and access to our ASCO (Free ASCO Whitepaper)21 Virtual Scientific Program data presentations (for registered participants).

About Advanced Prostate Cancer
Prostate cancer is a form of cancer that develops in the prostate gland, a small walnut shaped gland in the pelvis of men. In castration resistant prostate cancer (CRPC), the tumor shows signs of growth, such as rising Prostate Specific Antigen (PSA) levels, despite the use of hormone treatments that lower testosterone7. In metastatic CRPC (mCRPC), the tumor spreads to other parts of the body, such as neighboring organs or bones and remains unresponsive to hormone treatment7. The five-year survival rate for patients with metastatic prostate cancer is approximately 30%2.

About Phenotypic Precision Medicine in Advanced Prostate Cancer
Despite advances in prostate cancer care, there is a high unmet need for new targeted treatment options to improve outcomes for patients with mCRPC. More than 80% of prostate cancer tumors highly express a phenotypic biomarker6 called Prostate Specific Membrane Antigen (PSMA) 3-5,8-9, making it a promising diagnostic (through positron emission tomography (PET) scan imaging) and potential therapeutic target for radioligand therapy10. This differs from ‘genotypic’ precision medicine which targets specific genetic alterations in cancer cells6.

About 177Lu-PSMA-617
177Lu-PSMA-617 is an investigational PSMA-targeted radioligand therapy for metastatic castration-resistant prostate cancer. It is a type of precision cancer treatment combining a targeting compound (ligand) with a therapeutic radioisotope (a radioactive particle)11-13. After administration into the bloodstream, 177Lu-PSMA-617 binds to prostate cancer cells that express PSMA14, a transmembrane protein, with high tumor-to-normal tissue uptake11,15,16. Once bound, emissions from the radioisotope damage tumor cells, disrupting their ability to replicate and/or triggering cell death17-19. The radiation from the radioisotope works over very short distances to limit damage to surrounding cells10,11,15.

About VISION
VISION is an international, prospective, randomized, open-label, multicenter, phase III study to assess the efficacy and safety of 177Lu-PSMA-617 (7.4 GBq administered by intravenous infusion every 6 weeks for a maximum of 6 cycles) plus investigator-chosen best standard of care in the investigational arm, versus best standard of care in the control arm20. Patients with PSMA PET-scan positive mCRPC, and progression after prior taxane and androgen receptor pathway inhibitors, were randomized in a 2:1 ratio in favor of the investigational arm20. The alternate primary endpoints were rPFS and OS20. The study enrolled 831 patients1.

On June 3, 2021 AstraZeneca reported that Results from the OlympiA Phase III trial showed MSD’s Lynparza (olaparib) demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival (iDFS) versus placebo in the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm) high-risk human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (Press release, AstraZeneca, JUN 3, 2021, View Source [SID1234583441]).

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The results will be presented during the plenary session of the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on 6 June 2021 (abstract LBA#1) and were published today in The New England Journal of Medicine.

An estimated 2.3 million people were diagnosed with breast cancer worldwide in 2020 and BRCA mutations are found in approximately 5% of breast cancer patients.1,2

Sue Friedman, Executive Director, Facing Our Risk of Cancer Empowered (FORCE) and member of the OlympiA trial steering committee, said: "While there have been great strides in the early treatment of breast cancer, the fear of cancer returning is still at the forefront of patients’ minds. New targeted treatment approaches are needed in the adjuvant setting that can help keep cancer and that fear at bay."

Andrew Tutt, chair of the OlympiA trial steering committee and professor of Oncology at The Institute of Cancer Research, London and Kings College London, said: "We are thrilled that our global academic and industry partnership in OlympiA has been able to help identify a possible new treatment option for patients with early-stage breast cancer and who have inherited mutations in their BRCA1 or BRCA2 genes. Patients with early-stage breast cancer who have inherited BRCA mutations are typically diagnosed at a younger age compared to those without such a mutation. Olaparib has the potential to be used as a follow-on to all the standard initial breast cancer treatments to reduce the rate of life-threatening recurrence and cancer spread for many patients identified through genetic testing to have mutations in these genes."

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: "This is the first time that any medicine targeting a BRCA mutation has demonstrated the potential to change the course of early-stage breast cancer and offer hope for a cure. By providing a treatment which significantly reduces the risk of breast cancer returning in these high-risk patients, we hope Lynparza will set a new benchmark demonstrating sustained clinical benefit. We are working with regulatory authorities to bring Lynparza to these patients as quickly as possible."

Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: "Results of the OlympiA trial represent a potential step forward for patients with high-risk early breast cancer. These new data support the importance of testing at diagnosis for BRCA1/2 mutations, which are actionable biomarkers that can help identify patients with early breast cancer who may be eligible for adjuvant treatment with Lynparza. Testing for BRCA mutations in addition to hormone receptor status and the expression of the HER2 protein will allow clinicians to better inform potential treatment plans for their patients."

In the overall trial population of patients who had completed local treatment and standard neoadjuvant or adjuvant chemotherapy, results showed Lynparza reduced the risk of invasive breast cancer recurrences, second cancers or death by 42% (based on a hazard ratio [HR] of 0.58; 99.5% confidence interval [CI] 0.41-0.82; p<0.0001). At three years, 85.9% of patients treated with Lynparza remained alive and free of invasive breast cancer and second cancers versus 77.1% on placebo.

Lynparza also demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of distant disease-free survival (DDFS) in the overall trial population. Lynparza reduced the risk of distant disease recurrence or death by 43% (based on an HR of 0.57; 99.5% CI 0.39-0.83; p<0.0001). At the time of this initial data cut-off, fewer deaths had occurred in patients receiving Lynparza, but the difference in overall survival (OS) did not reach statistical significance. The trial will continue to assess OS as a secondary endpoint.

In February 2021, the Independent Data Monitoring Committee recommended for the OlympiA trial to move to early primary analysis and reporting. Based on the planned interim analysis, the IDMC concluded that the trial crossed the superiority boundary for its primary endpoint of iDFS and demonstrated a sustainable and clinically relevant treatment effect for Lynparza versus placebo.

Summary of OlympiA results

Lynparza

(n=921)

Placebo

(n=915)

iDFS (primary endpoint)

HR (99.5% CI)

0.58 (0.41, 0.82)

p-value

p<0.0001

iDFS rates

One year

93.3%

88.4%

Two years

89.2%

81.5%

Three years

85.9%

77.1%

DDFS (secondary endpoint)

HR (99.5% CI)

0.57 (0.39, 0.83)

p-value

p<0.0001

DDFS rates

One year

94.3%

90.2%

Two years

90.0%

83.9%

Three years

87.5%

80.4%

OS at interim (secondary endpoint)ii

HR (99% CI)

0.68 (0.44, 1.05)

p-value

p=0.024

OS rates

One year

98.1%

96.9%

Two years

94.8%

92.3%

Three years

92.0%

88.3%

i The data cut-off date for the interim analysis was 27 March 2020.
ii Statistical significance not reached based on the interim analysis plan for alpha conservation for future survival analyses.

The safety and tolerability profile of Lynparza in this trial was in line with that observed in prior clinical trials. The most common adverse events (AEs) were nausea (57%), fatigue (40%), anaemia (23%) and vomiting (23%). Grade 3 or higher AEs were anaemia (9%), neutropenia (5%), leukopenia (3%), fatigue (2%), and nausea (1%). Approximately 10% of patients treated with Lynparza discontinued treatment early due to AEs.

OlympiA is a global collaborative Phase III trial coordinated by the Breast International Group (BIG) worldwide, in partnership with NRG Oncology, the US National Cancer Institute (NCI), Frontier Science & Technology Research Foundation (FSTRF), AstraZeneca and MSD.3 The trial is sponsored by NRG Oncology in the US and by AstraZeneca outside the US.

Lynparza is approved in the US, Japan, and a number of other countries for gBRCAm, HER2-negative, metastatic breast cancer previously treated with chemotherapy; in the EU, this includes locally advanced breast cancer.

Early breast cancer
Breast cancer is the most common cancer among women worldwide and an estimated 70% of all breast cancer is diagnosed at an early stage.4,5 Breast cancer is one of the most biologically diverse tumour types with various factors underlying its development and progression.6 The discovery of biomarkers in the development of breast cancer has greatly impacted scientific understanding of the disease and treatment of patients who develop the disease.7

OlympiA
OlympiA is a Phase III, double-blind, placebo-controlled, multicentre trial testing the efficacy and safety of Lynparza tablets versus placebo as adjuvant treatment in patients with gBRCAm, high-risk, HER2-negative early breast cancer, who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy. The primary endpoint of the trial is iDFS defined as time from randomisation to date of first loco-regional or distant recurrence, new cancer or death from any cause. Key secondary endpoints include OS and DDFS, which is defined as time from randomisation until documented evidence of first distant recurrence of breast cancer or death without distant recurrence.3

BIG
The Breast International Group (BIG) is an international not-for-profit organisation for academic breast cancer research groups from around the world, based in Brussels, Belgium.

Founded by leading European opinion leaders in 1999, the organisation aims to address fragmentation in breast cancer research and now represents a network of over 50 like-minded research groups affiliated with specialised hospitals, research centres and leading experts across approximately 70 countries on six continents.

BIG’s research is supported in part by its philanthropy unit, known as BIG against breast cancer, which is used to interact with the general public and donors, and to raise funds for BIG’s purely academic breast cancer trials and research programmes.

FSTRF
Frontier Science & Technology Research Foundation (FSTRF) is a non-profit, research organisation which supports research networks, pharmaceutical companies and investigators to conduct scientifically meaningful high-quality clinical trials. The OlympiA trial involved research staff in the US and in the Affiliate office in Scotland.

FSTRF works with scientists and technicians in more than 800 laboratories, universities and medical centres around the world to provide a comprehensive range of research services throughout the clinical trial process including design, analysis and reporting.

Through its work, FSTRF aims to advance the application of statistical science and practice and data management techniques in science, healthcare and education.

NRG Oncology
NRG Oncology is a network group funded by the US National Cancer Institute (NCI), a part of the National Institutes of Health. NRG Oncology brings together the National Surgical Adjuvant Breast and Bowel Project (NSABP), the Radiation Therapy Oncology Group (RTOG), and the Gynecologic Oncology Group (GOG), with the mission to improve the lives of cancer patients by conducting practice-changing multi-institutional clinical and translational research. NRG Oncology sponsored OlympiA in the US and collaborated with the other adult cancer clinical trials research groups funded by the NCI, Alliance, ECOG/ACRIN and the Southwest Oncology Group. The NCI and AstraZeneca are collaborating under a Cooperative Research and Development Agreement between the parties.

BRCA1 and BRCA2
BRCA1 and BRCA2 are human genes that produce proteins responsible for repairing damaged DNA and play an important role maintaining the genetic stability of cells. When either of these genes is mutated or altered such that its protein product either is not made or does not function correctly, DNA damage may not be repaired properly, and cells become unstable. As a result, cells are more likely to develop additional genetic alterations that can lead to cancer and confer sensitivity to PARP inhibitors including Lynparza.8-11

Lynparza
Lynparza (olaparib) is a first-in-class PARP inhibitor and the first targeted treatment to block DNA damage response (DDR) in cells/tumours harbouring a deficiency in homologous recombination repair (HRR), such as mutations in BRCA1 and/or BRCA2. Inhibition of PARP with Lynparza leads to the trapping of PARP bound to DNA single-strand breaks, stalling of replication forks, their collapse and the generation of DNA double-strand breaks and cancer cell death. Lynparza is being tested in a range of PARP-dependent tumour types with defects and dependencies in the DDR pathway.

Lynparza is currently approved in a number of countries, including those in the EU, for the maintenance treatment of platinum-sensitive relapsed ovarian cancer. It is approved in the US, the EU, Japan, China, and several other countries as 1st-line maintenance treatment of BRCA-mutated advanced ovarian cancer following response to platinum-based chemotherapy. It is also approved in the US, EU and Japan as a 1st-line maintenance treatment with bevacizumab for patients with HRD-positive advanced ovarian cancer (BRCAm and/or genomic instability). Lynparza is approved in the US, Japan, and a number of other countries for germline BRCA-mutated, HER2-negative, metastatic breast cancer, previously treated with chemotherapy; in the EU, this includes locally advanced breast cancer. It is also approved in the US, the EU, Japan and several other countries for the treatment of germline BRCAm metastatic pancreatic cancer. Lynparza is approved in the US for HRR gene-mutated metastatic castration-resistant prostate cancer (BRCAm and other HRR gene mutations) and in the EU and Japan for BRCAm metastatic castration-resistant prostate cancer. Regulatory reviews are underway in several countries for ovarian, breast, pancreatic and prostate cancers.

Lynparza, which is being jointly developed and commercialised by AstraZeneca and MSD, has been used to treat over 40,000 patients worldwide. Lynparza has the broadest and most advanced clinical trial development programme of any PARP inhibitor, and AstraZeneca and MSD are working together to understand how it may affect multiple PARP-dependent tumours as a monotherapy and in combination across multiple cancer types. Lynparza is the foundation of AstraZeneca’s industry-leading portfolio of potential new medicines targeting DDR mechanisms in cancer cells.

The AstraZeneca and MSD strategic oncology collaboration
In July 2017, AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US, known as MSD outside the US and Canada, announced a global strategic oncology collaboration to co-develop and co-commercialise Lynparza, the world’s first PARP inhibitor, and Koselugo (selumetinib), a mitogen-activated protein kinase (MEK) inhibitor, for multiple cancer types. Working together, the companies will develop Lynparza and Koselugo in combination with other potential new medicines and as monotherapies. Independently, the companies will develop Lynparza and Koselugo in combination with their respective PD-L1 and PD-1 medicines.

AstraZeneca in breast cancer
Driven by a growing understanding of breast cancer biology, AstraZeneca is starting to challenge, and redefine, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death.

AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment. AstraZeneca aims to continue to transform outcomes for HR-positive breast cancer with foundational medicines Faslodex (fulvestrant) and Zoladex (goserelin) and the next-generation SERD and potential new medicine camizestrant. PARP inhibitor, Lynparza (olaparib) is a targeted treatment option for metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD continue to research Lynparza in metastatic breast cancer patients with an inherited BRCA mutation and are exploring new opportunities to treat these patients earlier in their disease state.

Building on the first approval of Enhertu (trastuzumab deruxtecan), a HER2-directed antibody-drug conjugate (ADC), in previously treated HER2-positive metastatic breast cancer, AstraZeneca and Daiichi Sankyo are exploring its potential in earlier lines of treatment and in new breast cancer settings. To bring much needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is testing immunotherapy Imfinzi (durvalumab) in combination with other oncology medicines, including Lynparza and Enhertu, assessing the potential of AKT kinase inhibitor, capivasertib, in combination with chemotherapy, and collaborating with Daiichi Sankyo to explore the potential of TROP2-directed ADC, datopotamab deruxtecan.

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

On June 3, 2021 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported that Ron Peck, M.D., Chief Medical Officer, and Sean Cassidy, Chief Financial Officer, will participate in a fireside chat at the 42nd Annual Goldman Sachs Global Healthcare Conference on Thursday, June 10 at 10:30 a.m. ET (Press release, Arvinas, JUN 3, 2021, View Source [SID1234583440]).

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A live audio webcast of the presentation will be available here and on Arvinas’ website at www.arvinas.com. A replay of the webcast will be archived on Arvinas’ website for 30 days following the presentation.

On June 3, 2021 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported that Shehnaaz Suliman, M.D., MBA, M.Phil., president and chief operating officer of Alector, will participate in fireside chats at the following upcoming virtual investor conferences (Press release, Alector, JUN 3, 2021, View Source [SID1234583439]):

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The Goldman Sachs 42nd Annual Global Healthcare Conference – Thursday, June 10, 2021, at 4:40 p.m. ET
The BofA Securities 2021 Napa Biopharma Virtual Conference – Monday, June 14, 2021, at 5:30 p.m. ET
Live webcasts of both presentations will be available on the "Events & Presentations" page within the Investors section of the Alector website at View Source Replays of the webcasts will be available on the Alector website for 30 days following the presentation dates.

On June 3, 2021 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that members of its management team will participate in the Goldman Sachs 42nd Annual Global Healthcare Conference on Thursday, June 10, 2021 at 2:10 p.m. ET (Press release, Syndax, JUN 3, 2021, View Source [SID1234583438]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A live webcast of the presentation can be accessed from the Investor section of the Company’s website at www.syndax.com, where a replay of the event will also be available for a limited time.