On May 23, 2022 Enterome, a clinical stage biopharmaceutical company developing first-in-class immunomodulatory drugs based on its bacterial Mimicry drug discovery platform, today announces that its CEO, Pierre Belichard, will provide a company update (in person) at the Jefferies Healthcare Conference in New York City, US which will take place June 8-10, 2022 (Press release, Enterome, MAY 23, 2022, View Source [SID1234614931]).

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In his presentation, Dr. Belichard will provide an overview of the progress the Company has made with its advanced OncoMimics pipeline, including its first-in-class off-the-shelf therapeutic cancer vaccine, EO2401, as well as its other fully owned EndoMimics pipeline for immune diseases using its Mimicry drug discovery platform.

On May 23, 2022 AstraZeneca reported that advances its ambition to redefine cancer care with new data to be presented across its diverse and industry-leading portfolio of cancer medicines at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, 3 to 7 June 2022 (Press release, AstraZeneca, MAY 23, 2022, View Source [SID1234614930]).

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A total of 18 approved and potential new medicines from AstraZeneca will be featured across more than 100 abstracts, including nine oral presentations and a plenary presentation of the DESTINY-Breast04 Phase III trial for Enhertu (trastuzumab deruxtecan) in HER2-low metastatic breast cancer.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: "Our five leading Oncology medicines have each set new standards for patient outcomes across many cancers. Our data at ASCO (Free ASCO Whitepaper) will showcase our continued investment in driving innovation with these medicines as well as their long-term impact in real-world settings. In particular, the groundbreaking data from DESTINY-Breast04 will show the potential of Enhertu to treat patients with HER2-low metastatic breast cancer who have never before been eligible for HER2-targeted treatments."

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "At AstraZeneca, we are pioneering new biomarkers and novel therapeutic modalities in our ambition to attack cancer from every angle and deliver personalised medicines to more patients. The results from DESTINY-Breast04 support the potential for Enhertu to redefine the classification and treatment of breast cancer across the spectrum of HER2 expression. We are also excited to share promising clinical data for our bispecific PD1-CTLA4 antibody MEDI5752 in advanced renal cell carcinoma, designed to have both of these clinically validated checkpoint targets in one molecule, delivering efficacy with an improved tolerability profile."

Leading through disruption in breast cancer
A late-breaking plenary presentation will highlight the potentially practice-changing results of the DESTINY-Breast04 trial of Enhertu in patients with HER2-low metastatic breast cancer. DESTINY-Breast04 is the first-ever Phase III trial of a HER2-directed therapy to show statistically significant and clinically meaningful benefit in both progression-free survival (PFS) and overall survival (OS) in patients with HER2-low unresectable and/or metastatic breast cancer regardless of hormone receptor status compared to standard-of-care chemotherapy.

Additionally, data from a retrospective study will estimate the prevalence of HER2-low breast cancer and describe its clinical and pathological characteristics, to help identify patients with HER2-low expressing tumours who may benefit from HER2-targeted therapy.

Further results will be shared from dose-finding and dose-expansion studies of Enhertu in combination with other anti-cancer agents in patients with advanced or metastatic HER2-positive breast cancer (DESTINY-Breast07) and HER2-low breast cancer (DESTINY-Breast08).

Data will also be presented from a safety follow-up of the DESTINY-Breast03 Phase III trial of Enhertu in the treatment of patients with unresectable or metastatic HER2-positive breast cancer previously treated with trastuzumab and a taxane. Enhertu was recently approved in the US for patients in this setting.

Revealing the full potential of an industry-leading portfolio and pipeline
Beyond breast cancer, AstraZeneca will share results from multiple trials highlighting its focus on delivering life-changing cancer medicines for patients with high unmet need. Data will also support the Company’s commitment to realising the full potential of its leading medicines with ongoing analyses, real-world data and research into novel combinations.

· MEDI5752 – An oral presentation will share safety and clinical activity results for MEDI5752 in patients with advanced renal cell carcinoma as a monotherapy treatment. MEDI5752 is a novel bispecific antibody that simultaneously targets the immune checkpoint proteins PD-1 and CTLA-4.

· Calquence (acalabrutinib) – Updated data from the ELEVATE-TN and ASCEND Phase III trials will highlight long-term safety and efficacy results of Calquence in patients with chronic lymphocytic leukaemia (CLL) regardless of line of therapy.

Presentations include updated data with approximately five-years of median follow-up from the ELEVATE-TN trial, which has demonstrated sustained clinical benefit of Calquence either in combination with obinutuzumab or as monotherapy compared to obinutuzumab plus chlorambucil, providing flexibility to tailor treatment for adults with treatment-naïve CLL.

Additionally, updated results from the ASCEND Phase III trial with approximately four years of median follow-up will highlight the sustained reduction of disease progression or death for Calquence compared to idelalisib plus rituximab or bendamustine plus rituximab in patients with relapsed or refractory CLL, as well as a maintained safety profile.

· Imfinzi (durvalumab) – Patient-reported outcomes from the HIMALAYA trial will highlight quality of life for patients treated with a single priming dose of tremelimumab added to Imfinzi in 1st-line unresectable liver cancer (STRIDE regimen). HIMALAYA is the first Phase III trial to show that a dual immunotherapy regimen has improved OS versus sorafenib in this setting. Tremelimumab with Imfinzi was recently accepted under Priority Review in the US by the Food and Drug Administration (FDA) based on this trial.

Patient-reported outcomes will also be presented from the TOPAZ-1 trial of Imfinzi plus standard-of-care chemotherapy (gemcitabine plus cisplatin) in 1st-line advanced biliary tract cancer. TOPAZ-1 is the first Phase III trial to show improved survival with an immunotherapy combination versus chemotherapy alone in this setting.

An additional regional subgroup analysis for the TOPAZ-1 trial will compare efficacy outcomes, including OS, for Asian patients with other geographies. Imfinzi plus chemotherapy was recently granted Priority Review in the US by the FDA based on this trial.

Further clinically relevant safety data from the positive POSEIDON Phase III trial of Imfinzi, tremelimumab and chemotherapy in 1st-line metastatic non-small cell lung cancer (NSCLC) will also be presented.

· Lynparza (olaparib) – Data from the PROpel Phase III trial will further reinforce the safety profile of Lynparza plus abiraterone in the treatment of 1st-line metastatic castration-resistant prostate cancer (mCRPC). These data build on PROpel efficacy data, which demonstrated that this combination significantly delayed disease progression versus standard-of-care abiraterone in 1st-line mCRPC in patients with or without homologous recombination repair gene mutations. Lynparza is the first PARP inhibitor to demonstrate clinical benefit in combination with a new hormonal agent versus abiraterone alone in this setting.

· Tagrisso (osimertinib) – Results will be shared from the externally sponsored OPAL Phase II trial in previously untreated EGFR-mutated (EGFRm) NSCLC that evaluated whether the addition of platinum-based chemotherapy to Tagrisso can improve patient outcomes. This combination is also being tested in the ongoing FLAURA2 Phase III trial.

Real-world data will also be presented to better inform unmet needs and treatment strategies among patients with resectable early-stage NSCLC, providing valuable insights into EGFRm disease prevalence and rates of recurrence, despite adjuvant chemotherapy, in this population. Tagrisso is approved for the adjuvant treatment of early-stage (IB, II and IIIA) EGFRm NSCLC based on the ADAURA Phase III trial.

Collaboration in the scientific community is critical to improving outcomes for patients. AstraZeneca is collaborating with Daiichi Sankyo Company Limited to develop and commercialise Enhertu and with MSD (Merck & Co., Inc. in the US and Canada) to develop and commercialise Lynparza.

Key AstraZeneca presentations during ASCO (Free ASCO Whitepaper) 2022

Lead author

Abstract title

Presentation details

Antibody drug conjugates

Modi, S

Trastuzumab deruxtecan (T-DXd) versus treatment of physician’s choice (TPC) in patients (pts) with HER2-low unresectable and/or metastatic breast cancer (mBC): Results of DESTINY-Breast04, a randomized, phase 3 study.

Abstract #LBA3

Plenary Session

5 June 2022

2:17pm (CDT)

Hamilton, EP

Trastuzumab deruxtecan (T-DXd) versus trastuzumab emtansine (T-DM1) in patients (pts) with HER2-positive (HER2+) unresectable and/or metastatic breast cancer (mBC): Safety follow-up of the randomized, phase 3 study DESTINY-Breast03.

Abstract #1000

Oral Abstract Session Breast Cancer—Metastatic

4 June 2022

1:15pm (CDT)

Andre, F

Dose-finding and -expansion studies of trastuzumab deruxtecan in combination with other anti-cancer agents in patients (pts) with advanced/metastatic HER2+ (DESTINY-Breast07 [DB-07]) and HER2-low (DESTINY-Breast08 [DB-08]) breast cancer (BC).

Abstract #3025

Poster Session Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

5 June 2022

8:00am (CDT)

Immuno-Oncology

Cho, BC

Durvalumab (D) +/- tremelimumab (T) + chemotherapy (CT) in first-line (1L) metastatic (m) NSCLC: AE management in POSEIDON.

Abstract #9035

Poster Session Lung Cancer—Non-Small Cell Metastatic

6 June 2022

8:00am (CDT)

Sangro, B

Patient-reported outcomes from the phase 3 HIMALAYA study of tremelimumab plus durvalumab in unresectable hepatocellular carcinoma.

Abstract #4074

Poster Session Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

4 June 2022

8:00am (CDT)

Burris III, HA

Patient-reported outcomes for the phase 3 TOPAZ-1 study of durvalumab plus gemcitabine and cisplatin in advanced biliary tract cancer.

Abstract #4070

Poster Session Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

4 June 2022

8:00am (CDT)

Vogel, A

Regional subgroup analysis of the phase 3 TOPAZ-1 study of durvalumab (D) plus gemcitabine and cisplatin (GC) in advanced biliary tract cancer (BTC).

Abstract #4075

Poster Session Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

4 June 2022

8:00am (CDT)

Özgüroğlu, M

Adverse events self-reported by patients (pts) with extensive-stage small cell lung cancer (ES-SCLC) treated with durvalumab (D) plus platinum-etoposide (EP) or EP in the CASPIAN study.

Abstract #8571

Poster Session Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

6 June 2022

8:00am (CDT)

Albiges, L

Safety and clinical activity of MEDI5752, a PD-1/CTLA-4 bispecific checkpoint inhibitor, as monotherapy in patients (pts) with advanced renal cell carcinoma (RCC): Preliminary results from an FTIH trial.

Abstract #107

Clinical Science Symposium Bispecifics: Are Two Better Than One?

5 June 2022

10:33am (CDT)

DNA damage response

Pignata, S

Maintenance olaparib in patients (pts) with platinum-sensitive relapsed ovarian cancer (PSROC) by somatic (s) or germline (g) BRCA and other homologous recombination repair (HRR) gene mutation status: Overall survival (OS) results from the ORZORA study.

Abstract #5519

Poster Discussion Session Gynecologic Cancer

4 June 2022

4:30pm (CDT)

Thiery-Vuillemin, A

Tolerability of abiraterone (abi) combined with olaparib (ola) in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC): Further results from the phase III PROpel trial.

Abstract #5019

Poster Discussion Session Genitourinary Cancer—Prostate, Testicular, and Penile

6 June 2022

5:26pm (CDT)

Armstrong, AJ

Olaparib plus abiraterone as first-line therapy in men with metastatic castration-resistant prostate cancer: Pharmacokinetics data from the PROpel trial.

Abstract #5050

Poster Session Genitourinary Cancer—Prostate, Testicular, and Penile

6 June 2022

1:15pm (CDT)

Eskander, RN

Real-world effectiveness of first-line maintenance olaparib in women with BRCA-mutated advanced ovarian cancer: U.S. retrospective cohort study.

Abstract #5518

Poster Discussion Session Gynecologic Cancer

4 June 2022

4:30pm (CDT)

Tumour drivers and resistance

Jones, RH

Fulvestrant plus capivasertib versus fulvestrant plus placebo after relapse or progression on an aromatase inhibitor in metastatic, estrogen receptor–positive breast cancer (FAKTION): Overall survival and updated progression-free survival data with enhanced biomarker analysis.

Abstract #1005

Oral Abstract Session Breast Cancer—Metastatic

4 June 2022

2:39pm (CDT)

Nakamura, A

A phase II study of osimertinib in combination with platinum plus pemetrexed in patients with EGFR-mutated, advanced non–small cell lung cancer: The OPAL study (NEJ032C/LOGIK1801).

Abstract #9097

Poster Session Lung Cancer—Non-Small Cell Metastatic

6 June 2022

8:00am (CDT)

Haematology

Sharman, JP

Acalabrutinib ± obinutuzumab versus obinutuzumab + chlorambucil in treatment-naïve chronic lymphocytic leukemia: Five-year follow-up of ELEVATE-TN.

Abstract #7539

Poster Session Hematologic Malignancies—Lymphoma and Chronic Lymphocytic Leukemia

4 June 2022

8:00am (CDT)

Notes

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 May 22, 2022 Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer, reported that the first patient has been dosed in the single-arm Phase I/II SWATCH Study (the "SWATCH" study), designed to evaluate the safety, tolerability and preliminary efficacy of XPOVIO (selinexor) in combination with the R2 regimen of lenalidomide plus rituximab for the treatment of relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) and relapsed/refractory indolent non-Hodgkin lymphoma (R/R iHNL) (Press release, Antengene, MAY 22, 2022, View Source [SID1234614929]).

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"Antengene is dedicated to making selinexor widely available for patients in China. Formal launch of the product, inclusion in practice guidelines and conduct of additional studies in new indications and with new treatment regimens are all essential parts of our plan. We are very pleased to initiate the SWATCH study in China," said Dr. Kevin Lynch, Antengene’s Chief Medical Officer. "While there have been promising advances in patient care for hematologic malignancies, including R/R DLBCL and R/R iNHL, these cancers are among the top-10 cancer types worldwide and there is still a major need for improved treatments. We are hopeful that the results of the SWATCH study will pave the way to further improve the care of patient with R/R DLBCL and R/R iNHL, in China."

About the SWATCH Study

This open-label, multicenter, single-arm Phase 1/2 SWATCH study is comprised of a dose-escalation phase and a dose-expansion phase. It is designed to evaluate the safety, tolerability, and preliminary efficacy of selinexor in combination with lenalidomide and rituximab (R2) for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) and relapsed/refractory indolent non-Hodgkin lymphoma (R/R iNHL).

The primary endpoints of the SWATCH study are the maximum-tolerated dose (MTD) and/or the recommended Phase II dose (RP2D) of the SR2 regimen determined by the dose-limiting toxicity (DLT) in patients with R/R DLBCL in the dose-escalation phase, as well as the safety and tolerability of the SR2 regimen determined by the key safety measures including adverse events (AEs) and serious AEs (SAEs). Secondary endpoints include the objective response rate (ORR), progression-free survival (PFS), and duration of response (DOR) of the SR2 regimen as assessed per the Lugano 2014 criteria for the assessment of lymphoma (Cheson, 2014).

About Diffuse Large B-Cell Lymphoma

Diffuse large B-cell Lymphoma (DLBCL) is an aggressive hematologic malignancy and the most common subtype of lymphoma in China1. It accounts for 60% of B-cell lymphoma in East Asia2.

While there have been promising medical advances, treatment options are still limited and there remains an enormous unmet medical need in patients with DLBCL. It is estimated that about half of patients with DLBCL will not achieve complete remission after receiving first-line treatment, and approximately 60% of patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) continue to lack effective treatment options.

About Indolent Non-Hodgkin Lymphoma

Indolent Non-Hodgkin Lymphoma (iNHL) is a hematological malignancy that accounts for 21% of all NHL incidences in China3.

Although the first-line treatment with rituximab in combination with various chemotherapies can deliver significant improvement to the overall survival (OS) of patients with iNHL, the majority of patients with R/R iNHL would still relapse and eventually become refractory, thus presenting an urgent need for novel drugs and combination therapies that can effectively improve treatment comes for patients with R/R iNHL.

About XPOVIO (selinexor)

XPOVIO is the first and only oral XPO1 inhibitor approved by the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/refractory multiple myeloma (R/R MM) and relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL). By blocking the nuclear export protein XPO1, selinexor can promote the intranuclear accumulation and activation of tumor suppressor proteins and growth regulating proteins and down-regulate the levels of multiple oncogenic proteins. Based on its novel mechanism of action, selinexor is being evaluated for use in multiple combination regimens in hematological and solid tumor cancers to improve treatment efficacy.

Antengene secured approval of selinexor in China in December 2021 for R/R MM. Antengene has also secured approval for XPOVIO in South Korea for use in R/R MM and R/R DLBCL, in Singapore for use in R/R MM and R/R DLBCL and in Australia for use in R/R MM. Antengene is conducting 10 clinical studies in mainland China (3 in collaboration with Karyopharm Therapeutics Inc. [Nasdaq:KPTI]) for relapsed/refractory hematological malignancies and advanced solid tumors.

On May 21, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported data showing its blood-based multimodal test achieved clinically significant thresholds of sensitivity and specificity in detecting colorectal cancer (CRC) (Press release, Guardant Health, MAY 21, 2022, View Source [SID1234614928]). These data were presented during an oral presentation at Digestive Disease Week 2022.

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The assay used in this analysis integrates genomics and epigenomics for CRC detection. An updated version of this assay that incorporates the use of proteomics, Shield, is now available as a laboratory developed test for eligible individuals by prescription only through healthcare professionals.

"Colorectal cancer is curable if detected early, and yet many adults are not up to date with recommended colorectal screening. Offering eligible individuals a blood-based test could help overcome many barriers associated with currently available methods, such as a colonoscopy or a stool-based test," said Paloma Peinado, MD, HM Hospitales, Madrid, Spain. "These data are the first from a prospective study to suggest that this blood-based multimodal test demonstrates the sensitivity and specificity needed to make it a screening option for colorectal cancer."

The ongoing prospective observational study is being conducted at four hospitals in Spain. The data presented include 557 individuals who had a complete colonoscopy and results from the blood-based multimodal CRC test. The median age was 55 years (range 45-84 years; 21% age 45-49, 75% age 50-74, 4% age 75+), and 52% of the cohort was female. Sensitivity (detection rate) for colorectal cancer was determined at 90% and 95% specificity (true negative rate).

At 90% specificity the assay achieved 100% sensitivity (8/8; Stage I,1/1; Stage II,3/3; Stage III,2/2; Stage IV,2/2). At 95% specificity, the assay achieved sensitivity for CRC at 88% (7/8): Stage I (1/1), Stage II (2/3), Stage III (2/2), Stage IV (2/2).

"We are pleased to report these prospective data further illustrate the promise of our multimodal assay as a highly sensitive blood-based screening test for colorectal cancer," said AmirAli Talasaz, Guardant Health co-CEO. "Though curable if caught early, colorectal cancer remains the third most common cancer worldwide. As a convenient screening tool that only requires a simple blood draw, our multimodal assay has the potential to help increase adherence to recommended screening guidelines to save lives."

On May 21, 2022 Aclys Bio reported that it will be attending the 2022 BIO International Convention in San Diego June 13 – 16 (Press release, Aclys Bio, MAY 21, 2022, View Source [SID1234614926]). Aclys will be scheduling meetings with a number of potential partners to discuss Aclys’s pipeline of antibody-based therapeutics for Precision Oncology.

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