On September 7, 2021 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that it will present new research data across its antibody drug conjugate (ADC) portfolio in a broad range of cancers at the 2021 European Society for Medical Oncology (#ESMO21) Virtual Congress to be held September 16 to 21, 2021 (Press release, Daiichi Sankyo, SEP 7, 2021, https://www.businesswire.com/news/home/20210907005291/en/Daiichi-Sankyo-Advances-Leadership-in-Oncology-with-Potentially-Practice-Changing-Data-at-2021-ESMO-Congress [SID1234587334]). Four late-breaking presentations, including a Presidential Symposium, showcase Daiichi Sankyo’s growing leadership in creating transformative medicines for patients with cancer.

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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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Data demonstrating superior progression-free survival results in a head-to-head comparison of ENHERTU (trastuzumab deruxtecan) versus trastuzumab emtansine (T-DM1) in patients with previously treated HER2 positive metastatic breast cancer from the DESTINY-Breast03 phase 3 trial will be highlighted during a Presidential Symposium.

Other late-breaking ENHERTU data at ESMO (Free ESMO Whitepaper) includes primary data from the HER2 mutated metastatic non-small cell lung cancer (NSCLC) cohort of the DESTINY-Lung01 phase 2 trial and the first results from the DESTINY-Gastric02 phase 2 trial in patients with HER2 positive unresectable gastric or gastroesophageal junction (GEJ) adenocarcinoma. Updated overall survival data from the DESTINY-Breast01 phase 2 trial also will be presented.

"At this year’s ESMO (Free ESMO Whitepaper), Daiichi Sankyo’s growing leadership in oncology will be demonstrated through the potentially practice-changing results from the DESTINY-Breast03 and DESTINY-Lung01 trials, which showcase the transformative nature of ENHERTU in HER2 positive metastatic breast cancer and HER2 mutated metastatic non-small cell lung cancer," said Ken Takeshita, MD, Global Head, Research and Development, Daiichi Sankyo. "Other impressive data across our ADC portfolio, including datopotamab deruxtecan and DS-7300, continue to demonstrate the strength of Daiichi Sankyo’s ADC technology across multiple cancers."

The fourth late-breaking presentation will highlight promising results from a sub-group analysis of the patients with advanced/metastatic NSCLC and actionable genomic alterations from the TROPION-PanTumor01 phase 1 trial of datopotamab deruxtecan (Dato-DXd) in solid tumors.

Preliminary results from the phase 1/2 clinical trial of DS-7300, a B7-H3 directed ADC, in patients with advanced solid tumors will be featured as a Proffered Paper presentation. Preclinical research on DS-6000, a CDH6 directed ADC, also will be presented during the meeting.

Daiichi Sankyo will hold a conference call for investors and analysts on Tuesday, September 21, 2021 at 6:30 pm EDT. Ken Takeshita, MD, Global Head, Research and Development, Daiichi Sankyo, will provide an overview of the ESMO (Free ESMO Whitepaper) and World Conference on Lung Cancer (WCLC) research data and address questions from investors and analysts.

Following is an overview of the late-breaking research data from the oncology portfolio of Daiichi Sankyo to be presented at ESMO (Free ESMO Whitepaper) 2021:

Presentation Title

Author

Abstract ID

Presentation Details

Late-Breaking Presentations

ENHERTU

Breast

Trastuzumab Deruxtecan (T-DXd) vs.
Trastuzumab Emtansine (T-DM1) in
Patients With HER2+ Metastatic Breast
Cancer (mBC): Results of the Randomized
Phase 3 DESTINY-Breast03 Study

J. Cortés

#LBA1

Presidential Symposium
Saturday, September 18
15:05 – 15:20 CEST

Lung

Primary Data from DESTINY-Lung01: A
Phase 2 Trial of Trastuzumab Deruxtecan
(T-DXd) in Patients With HER2 Mutated
(HER2m) Metastatic Non–Small Cell Lung
Cancer (NSCLC)

B. Li

#LBA45

Proffered Paper Session
NSCLC, Metastatic
Saturday, September 18
14:10 – 14:20 CEST

Gastric

Primary Analysis of a Phase 2 Single-Arm
Trial of Trastuzumab Deruxtecan (T-DXd)
in Western Patients With HER2 Positive
(HER2+) Unresectable or Metastatic
Gastric or Gastroesophageal Junction (GEJ)
Cancer Who Progressed on or After a
Trastuzumab-containing Regimen

E. Van Cutsem

#LBA55

Mini Oral Session
Gastrointestinal Tumors, Non-colorectal
Friday, September 17
17:45 – 17:50 CEST

Dato-DXd

Lung

Efficacy of Datopotamab Deruxtecan
(Dato-DXd) in Patients With
Advanced/Metastatic Non-Small Cell Lung
Cancer (NSCLC) and Actionable Genomic
Alterations (AGAs): Preliminary Results
from the Phase 1 TROPION-PanTumor01
Study

E. Garon

#LBA49

Mini Oral Session
NSCLC, Metastatic
Sunday, September 19
17:30 – 17:35 CEST

Other data presentations from the oncology portfolio of Daiichi Sankyo to be presented include:

Presentation Title

Author

Abstract ID

Presentation Details

DS-7300

Solid Tumors

A Phase 1/2 Multicenter, First-in-Human Study
of DS-7300 (B7-H3 DXd-ADC) in Patients With
Advanced Solid Tumors

M. Johnson

Presentation

#513O

Proffered Paper Session
Developmental Therapeutics

Friday, September 17

14:10 – 14:20 CEST

ENHERTU

Breast

Trastuzumab Deruxtecan (T-DXd) in Patients
With HER2 Positive Metastatic Breast Cancer
(MBC): Updated Survival Results from a Phase 2
Trial (DESTINY-Breast01)

C. Saura

#279P

ePoster

Phase 3 Study of Trastuzumab Deruxtecan (T-DXd)
With or Without Pertuzumab vs a Taxane,
Trastuzumab and Pertuzumab in First Line (1L),
Human Epidermal Growth Factor Receptor 2–positive
(HER2+) Metastatic Breast Cancer (mBC):
DESTINY-Breast09

S. Tolaney

#328TiP

ePoster

Open-label, Multinational, Multicenter, Phase
3b/4 Study of Trastuzumab Deruxtecan (T-DXd)
in Patients With or Without Baseline Brain
Metastasis With Previously Treated
Advanced/Metastatic Human Epidermal Growth
Factor Receptor 2–positive Breast Cancer
(HER2+ BC): DESTINY-Breast12

N. Lin

#335TiP

ePoster

A Retrospective Population-based Observational
Study in Metastatic HER2 Positive Breast Cancer
Patients in Denmark Previously Treated With
T-DM1

A. Due

#289P

ePoster

Burden of Illness of HER2+ in Metastatic Breast
Cancer (MBC) Patients: A Systematic Literature
Review (SLR)

G. Vondeling

#287P

ePoster

NSCLC

Trastuzumab Deruxtecan (T-DXd) in Patients
with HER2 Mutated (HER2m) Metastatic Non-Small
Cell Lung Cancer (NSCLC): A Phase 2 Study
(DESTINY-Lung02)

E. Smit

#1361TiP

ePoster

Gastric

Trastuzumab Deruxtecan (T-DXd) in Patients
With HER2 Positive Gastric Cancer (GC) or
Gastroesophageal Junction (GEJ)
Adenocarcinoma Who Have Progressed On or
After a Trastuzumab-Containing Regimen
(DESTINY-Gastric04, DG-04): A Randomized

Phase 3 Study

K. Shitara

#1436TiP

ePoster

Colorectal

Exploratory Biomarker Analysis of DESTINY-CRC01,
a Phase 2, Multicenter, Open-Label Study of
Trastuzumab Deruxtecan (T-DXd, DS-8201)
in Patients With HER2-Expressing Metastatic
Colorectal Cancer (mCRC)

S. Siena

#386O

Proffered Paper Session
Gastrointestinal Tumors, Colorectal
Saturday, September 18
13:40 – 13:50 CEST

Pan-Tumor

A Phase 2, Multicenter, Open-label Study
Evaluating Trastuzumab Deruxtecan (T-DXd)
For the Treatment of Select HER2 Expressing
Solid Tumors (DESTINY-PanTumor02)

F. Meric-Bernstam

#1869TiP

ePoster

DS-6000

Pre-Clinical

DS-6000a, a Novel CDH6-targeting Antibody-Drug
Conjugate With a Novel DNA Topoisomerase I
Inhibitor DXd, Demonstrates Potent Antitumor
Activity in Preclinical Models

H. Suzuki

#10P

ePoster

About the DXd ADC Portfolio of Daiichi Sankyo

The DXd ADC portfolio of Daiichi Sankyo currently consists of seven ADCs with six in clinical development across multiple types of cancer. The company’s three lead ADCs include ENHERTU, a HER2 directed ADC, and datopotamab deruxtecan (Dato-DXd), a TROP2 directed ADC, which are being jointly developed and commercialized globally with AstraZeneca; and patritumab deruxtecan (HER3-DXd), a HER3 directed ADC. Three additional ADCs including DS-7300 (B7-H3), DS-6157 (GPR20) and DS-6000 (CDH6) are being developed through a strategic collaboration with Sarah Cannon Research Institute.

Each ADC is designed using Daiichi Sankyo’s proprietary DXd ADC technology to target and deliver chemotherapy inside cancer cells that express a specific cell surface antigen. Each ADC consists of a monoclonal antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, via a stable tetrapeptide-based cleavable linker.

ENHERTU (5.4 mg/kg) is approved in Canada, EU, Israel, Japan, UK and U.S. for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting based on the results from the DESTINY-Breast01 trial.

ENHERTU (6.4 mg/kg) is also approved in Israel, Japan and U.S. for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01 trial.

ENHERTU is approved in the U.S. with Boxed WARNINGS for Interstitial Lung Disease and Embryo-Fetal Toxicity. For more information, please see the accompanying full Prescribing Information, including Boxed WARNINGS, and Medication Guide.

Datopotamab deruxtecan, patritumab deruxtecan, DS-7300, DS-6157 and DS-6000 are investigational medicines that have not been approved for any indication in any country. Safety and efficacy have not been established.

U.S. Important Safety Information for ENHERTU

Indications
ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with:

Unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.

This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.
WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO-FETAL TOXICITY

Interstitial lung disease (ILD) and pneumonitis, including fatal cases, have been reported with ENHERTU. Monitor for and promptly investigate signs and symptoms including cough, dyspnea, fever, and other new or worsening respiratory symptoms. Permanently discontinue ENHERTU in all patients with Grade 2 or higher ILD/pneumonitis. Advise patients of the risk and to immediately report symptoms.
Exposure to ENHERTU during pregnancy can cause embryo-fetal harm. Advise patients of these risks and the need for effective contraception.
Contraindications
None.

Warnings and Precautions
Interstitial Lung Disease / Pneumonitis
Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients treated with ENHERTU. Advise patients to immediately report cough, dyspnea, fever, and/or any new or worsening respiratory symptoms. Monitor patients for signs and symptoms of ILD. Promptly investigate evidence of ILD. Evaluate patients with suspected ILD by radiographic imaging. Consider consultation with a pulmonologist. For asymptomatic ILD/pneumonitis (Grade 1), interrupt ENHERTU until resolved to Grade 0, then if resolved in ≤28 days from date of onset, maintain dose. If resolved in >28 days from date of onset, reduce dose one level. Consider corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥0.5 mg/kg/day prednisolone or equivalent). For symptomatic ILD/pneumonitis (Grade 2 or greater), permanently discontinue ENHERTU. Promptly initiate systemic corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥1 mg/kg/day prednisolone or equivalent) and continue for at least 14 days followed by gradual taper for at least 4 weeks.

Metastatic Breast Cancer
In clinical studies, of the 234 patients with unresectable or metastatic HER2-positive breast cancer treated with ENHERTU 5.4 mg/kg, ILD occurred in 9% of patients. Fatal outcomes due to ILD and/or pneumonitis occurred in 2.6% of patients treated with ENHERTU. Median time to first onset was 4.1 months (range: 1.2 to 8.3).

Locally Advanced or Metastatic Gastric Cancer
In DESTINY-Gastric01, of the 125 patients with locally advanced or metastatic HER2‑positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, ILD occurred in 10% of patients. Median time to first onset was 2.8 months (range: 1.2 to 21.0).

Neutropenia
Severe neutropenia, including febrile neutropenia, can occur in patients treated with ENHERTU. Monitor complete blood counts prior to initiation of ENHERTU and prior to each dose, and as clinically indicated. For Grade 3 neutropenia (Absolute Neutrophil Count [ANC] <1.0 to 0.5 x 109/L) interrupt ENHERTU until resolved to Grade 2 or less, then maintain dose. For Grade 4 neutropenia (ANC <0.5 x 109/L) interrupt ENHERTU until resolved to Grade 2 or less. Reduce dose by one level. For febrile neutropenia (ANC <1.0 x 109/L and temperature >38.3ºC or a sustained temperature of ≥38ºC for more than 1 hour), interrupt ENHERTU until resolved. Reduce dose by one level.

Metastatic Breast Cancer
In clinical studies, of the 234 patients with unresectable or metastatic HER2-positive breast cancer who received ENHERTU 5.4mg/kg, a decrease in neutrophil count was reported in 62% of patients. Sixteen percent had Grade 3 or 4 decrease in neutrophil count. Median time to first onset of decreased neutrophil count was 23 days (range: 6 to 547). Febrile neutropenia was reported in 1.7% of patients.

Locally Advanced or Metastatic Gastric Cancer
In DESTINY-Gastric01, of the 125 patients with locally advanced or metastatic HER2‑positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, a decrease in neutrophil count was reported in 72% of patients. Fifty-one percent had Grade 3 or 4 decreased neutrophil count. Median time to first onset of decreased neutrophil count was 16 days (range: 4 to 187). Febrile neutropenia was reported in 4.8% of patients.

Left Ventricular Dysfunction
Patients treated with ENHERTU may be at increased risk of developing left ventricular dysfunction. Left ventricular ejection fraction (LVEF) decrease has been observed with anti-HER2 therapies, including ENHERTU. In the 234 patients with unresectable or metastatic HER2-positive breast cancer who received ENHERTU, two cases (0.9%) of asymptomatic LVEF decrease were reported. In DESTINY-Gastric01, of the 125 patients with locally advanced or metastatic HER2‑positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, no clinical adverse events of heart failure were reported; however, on echocardiography, 8% were found to have asymptomatic Grade 2 decrease in LVEF. Treatment with ENHERTU has not been studied in patients with a history of clinically significant cardiac disease or LVEF <50% prior to initiation of treatment.

Assess LVEF prior to initiation of ENHERTU and at regular intervals during treatment as clinically indicated. When LVEF is >45% and absolute decrease from baseline is 10-20%, continue treatment with ENHERTU. When LVEF is 40-45% and absolute decrease from baseline is <10%, continue treatment with ENHERTU and repeat LVEF assessment within 3 weeks. When LVEF is 40-45% and absolute decrease from baseline is 10-20%, interrupt ENHERTU and repeat LVEF assessment within 3 weeks. If LVEF has not recovered to within 10% from baseline, permanently discontinue ENHERTU. If LVEF recovers to within 10% from baseline, resume treatment with ENHERTU at the same dose. When LVEF is <40% or absolute decrease from baseline is >20%, interrupt ENHERTU and repeat LVEF assessment within 3 weeks. If LVEF of <40% or absolute decrease from baseline of >20% is confirmed, permanently discontinue ENHERTU. Permanently discontinue ENHERTU in patients with symptomatic congestive heart failure.

Embryo-Fetal Toxicity
ENHERTU can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risks to a fetus. Verify the pregnancy status of females of reproductive potential prior to the initiation of ENHERTU. Advise females of reproductive potential to use effective contraception during treatment and for at least 7 months following the last dose of ENHERTU. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ENHERTU and for at least 4 months after the last dose of ENHERTU.

Additional Dose Modifications
Thrombocytopenia
For Grade 3 thrombocytopenia (platelets <50 to 25 x 109/L) interrupt ENHERTU until resolved to Grade 1 or less, then maintain dose. For Grade 4 thrombocytopenia (platelets <25 x 109/L) interrupt ENHERTU until resolved to Grade 1 or less. Reduce dose by one level.

Adverse Reactions
Metastatic Breast Cancer
The safety of ENHERTU was evaluated in a pooled analysis of 234 patients with unresectable or metastatic HER2-positive breast cancer who received at least one dose of ENHERTU 5.4 mg/kg in DESTINY-Breast01 and Study DS8201-A-J101. ENHERTU was administered by intravenous infusion once every three weeks. The median duration of treatment was 7 months (range: 0.7 to 31).

Serious adverse reactions occurred in 20% of patients receiving ENHERTU. Serious adverse reactions in >1% of patients who received ENHERTU were interstitial lung disease, pneumonia, vomiting, nausea, cellulitis, hypokalemia, and intestinal obstruction. Fatalities due to adverse reactions occurred in 4.3% of patients including interstitial lung disease (2.6%), and the following events occurred in one patient each (0.4%): acute hepatic failure/acute kidney injury, general physical health deterioration, pneumonia, and hemorrhagic shock.

ENHERTU was permanently discontinued in 9% of patients, of which ILD accounted for 6%. Dose interruptions due to adverse reactions occurred in 33% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose interruption were neutropenia, anemia, thrombocytopenia, leukopenia, upper respiratory tract infection, fatigue, nausea, and ILD. Dose reductions occurred in 18% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose reduction were fatigue, nausea, and neutropenia.

The most common (≥20%) adverse reactions, including laboratory abnormalities, were nausea (79%), white blood cell count decreased (70%), hemoglobin decreased (70%), neutrophil count decreased (62%), fatigue (59%), vomiting (47%), alopecia (46%), aspartate aminotransferase increased (41%), alanine aminotransferase increased (38%), platelet count decreased (37%), constipation (35%), decreased appetite (32%), anemia (31%), diarrhea (29%), hypokalemia (26%), and cough (20%).

Locally Advanced or Metastatic Gastric Cancer
The safety of ENHERTU was evaluated in 187 patients with locally advanced or metastatic HER2‑positive gastric or GEJ adenocarcinoma in DESTINY‑Gastric01. Patients intravenously received at least one dose of either ENHERTU (N=125) 6.4 mg/kg once every three weeks or either irinotecan (N=55) 150 mg/m2 biweekly or paclitaxel (N=7) 80 mg/m2 weekly for 3 weeks. The median duration of treatment was 4.6 months (range: 0.7 to 22.3) in the ENHERTU group and 2.8 months (range: 0.5 to 13.1) in the irinotecan/paclitaxel group.

Serious adverse reactions occurred in 44% of patients receiving ENHERTU 6.4 mg/kg. Serious adverse reactions in >2% of patients who received ENHERTU were decreased appetite, ILD, anemia, dehydration, pneumonia, cholestatic jaundice, pyrexia, and tumor hemorrhage. Fatalities due to adverse reactions occurred in 2.4% of patients: disseminated intravascular coagulation, large intestine perforation, and pneumonia occurred in one patient each (0.8%).

ENHERTU was permanently discontinued in 15% of patients, of which ILD accounted for 6%. Dose interruptions due to adverse reactions occurred in 62% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose interruption were neutropenia, anemia, decreased appetite, leukopenia, fatigue, thrombocytopenia, ILD, pneumonia, lymphopenia, upper respiratory tract infection, diarrhea, and hypokalemia. Dose reductions occurred in 32% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose reduction were neutropenia, decreased appetite, fatigue, nausea, and febrile neutropenia.

The most common (≥20%) adverse reactions, including laboratory abnormalities, were hemoglobin decreased (75%), white blood cell count decreased (74%), neutrophil count decreased (72%), lymphocyte count decreased (70%), platelet count decreased (68%), nausea (63%), decreased appetite (60%), anemia (58%), aspartate aminotransferase increased (58%), fatigue (55%), blood alkaline phosphatase increased (54%), alanine aminotransferase increased (47%), diarrhea (32%), hypokalemia (30%), vomiting (26%), constipation (24%), blood bilirubin increased (24%), pyrexia (24%), and alopecia (22%).

Use in Specific Populations

Pregnancy: ENHERTU can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risks to a fetus. There are clinical considerations if ENHERTU is used in pregnant women, or if a patient becomes pregnant within 7 months following the last dose of ENHERTU.
Lactation: There are no data regarding the presence of ENHERTU in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with ENHERTU and for 7 months after the last dose.
Females and Males of Reproductive Potential: Pregnancy testing: Verify pregnancy status of females of reproductive potential prior to initiation of ENHERTU. Contraception: Females: ENHERTU can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with ENHERTU and for at least 7 months following the last dose. Males: Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ENHERTU and for at least 4 months following the last dose. Infertility: ENHERTU may impair male reproductive function and fertility.
Pediatric Use: Safety and effectiveness of ENHERTU have not been established in pediatric patients.
Geriatric Use: Of the 234 patients with HER2-positive breast cancer treated with ENHERTU 5.4 mg/kg, 26% were ≥65 years and 5% were ≥75 years. No overall differences in efficacy were observed between patients ≥65 years of age compared to younger patients. There was a higher incidence of Grade 3-4 adverse reactions observed in patients aged ≥65 years (53%) as compared to younger patients (42%). Of the 125 patients with locally advanced or metastatic HER2‑positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg in DESTINY-Gastric01, 56% were ≥65 years and 14% were ≥75 years. No overall differences in efficacy or safety were observed between patients ≥65 years of age compared to younger patients.
Hepatic Impairment: In patients with moderate hepatic impairment, due to potentially increased exposure, closely monitor for increased toxicities related to the topoisomerase inhibitor.
To report SUSPECTED ADVERSE REACTIONS, contact Daiichi Sankyo, Inc. at 1-877-437-7763 or FDA at 1-800-FDA-1088 or fda.gov/medwatch.

Please see accompanying full Prescribing Information, including Boxed WARNINGS, and Medication Guide.

About Daiichi Sankyo in Oncology

The oncology portfolio of Daiichi Sankyo is powered by our team of world-class scientists that push beyond traditional thinking to create transformative medicines for people with cancer. Anchored by our DXd antibody drug conjugate (ADC) technology, our research engines include biologics, medicinal chemistry, modality and other research laboratories in Japan, and Plexxikon, our small molecule structure-guided R&D center in the U.S. We also work alongside leading academic and business collaborators to further advance the understanding of cancer as Daiichi Sankyo builds towards our ambitious goal of becoming a global leader in oncology by 2025.

On September 7, 2021 Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) reported it has commenced a collaboration with Kettering Health (KH), a faith-based network of 13 hospitals, emergency centers, and outpatient facilities located in Southwest Ohio; headquartered at the Kettering Memorial Hospital in Kettering, Ohio, United States (Press release, Telix Pharmaceuticals, SEP 7, 2021, View Source [SID1234587333]).

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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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The parties have signed a Memorandum of Understanding ("MOU") formalising their intent to work together to foster late-stage clinical research into Telix’s investigational PSMA1-targeting radiopharmaceuticals, illuccix (Kit for the preparation of 68Ga-PSMA-11 injection, for diagnostic imaging with positron emission tomography, (PET) and Lu-177 PSMA (TLX591, for radioligand therapy), and to establish Kettering Health as a regional centre of excellence for PET Molecular Imaging (Ml) and Theranostics, with an initial focus on the diagnosis and treatment of prostate cancer.

The MOU outlines the principles of the collaboration between Kettering Health and Telix. The parties intend to develop binding agreements for each aspect of the collaboration, based on the principles set out in the MOU.

Telix and Kettering Health plan to work closely with multiple industry leaders, culminating in the rapid implementation of PET MI technologies (imaging and theranostics) into clinical services for patients in the region. The aim is to capitalize on the growing demand for PET MI, catalysed by the exponential growth of new radiopharmaceuticals in the short term, and over the longer-term, develop a continuous pipeline of new technologies for diagnosis and treatment of multiple diseases.

Dr Martin Satter, Senior Molecular Imaging Scientist at Kettering Health said, "We believe PET Molecular Imaging has the potential to quickly redefine, reimagine and reinvent the diagnosis and treatment of cancer, Alzheimer’s, Parkinson’s, cardiac and other diseases. This belief has evolved and crystalized over our 30-year history in PET MI, and our current re-commitment to this technology including our recent upgrades of a medical cyclotron, radiochemistry lab and clean room, as well as a digital PET/CT2 scanner.

"We are excited to work with Telix – a global leader in the field of radiopharmaceuticals and radioligand therapy to foster research and innovation in a non-academic setting. Telix shares our commitment to bring personalized medicine to our region through these disruptive technologies."

Dr Bernard Lambert, President of Telix Americas said, "This is a collaboration that brings together leading industry, technical, academic and clinical resources to further explore the potential of our PSMA-targeting radiopharmaceuticals. It reinforces Telix’s position as a leading innovator in this field, with a commitment to driving forward both clinical development alongside the supply chain, to support the commercialisation journey."

On September 7, 2021 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients battling cancer, reported that management will present virtually at the following upcoming investor conferences (Press release, Verastem, SEP 7, 2021, View Source [SID1234587332]):

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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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H.C. Wainwright 23rd Annual Global Investment Conference on Monday, September 13, 2021 at 7:00 a.m. Eastern Time
Cantor Virtual Global Healthcare Conference on Monday, September 27, 2021 at 4:00 p.m. Eastern Time
A webcast of the presentations will be available on the investors section of the Company’s website at www.verastem.com. An archived presentation will be available for 90 days.

On September 7, 2021 Sierra Oncology, Inc. (NASDAQ: SRRA), a late-stage biopharmaceutical company on a mission to deliver targeted therapies that treat rare forms of cancer, reported the company will participate in three investor conferences in September 2021 (Press release, Sierra Oncology, SEP 7, 2021, View Source [SID1234587331]). Stephen Dilly, MBBS, PhD, President and Chief Executive Officer of Sierra Oncology will provide a company update at the HC Wainwright 23rd Annual Global Investment Conference and the Oppenheimer Fall Healthcare Life Sciences & Med Tech Summit. He will participate in a fireside chat discussion at the 2021 Cantor Virtual Global Healthcare Conference.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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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Presentation Details:

Conference: HC Wainwright 23rd Annual Global Investment Conference
Date: Monday, September 13, 2021
Time: On demand viewing beginning at 7:00 am ET

Conference: Oppenheimer Fall Healthcare Life Sciences & Med Tech Summit
Date: Tuesday, September 21, 2021
Time: Presentation beginning at 2:05 pm ET

Conference: 2021 Cantor Virtual Global Healthcare Conference
Date: Tuesday, September 28, 2021
Time: Fireside chat beginning at 4:00 pm ET
All three presentations will be webcast and available at the times noted above on the Investors section of Sierra’s corporate website in the Events & Webcast tab.

On September 7, 2021 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported that new oncology data will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, which will be held September 16-21, 2021 (Press release, Genentech, SEP 7, 2021, View Source [SID1234587330]). With one of the broadest oncology pipelines and portfolios in the industry, Genentech presentations include late-breaking abstracts featuring data in early-stage breast cancer and early-stage lung cancer, and a presentation on cancer of unknown primary (CUP), which has been selected for inclusion in the ESMO (Free ESMO Whitepaper) Press Program.

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"Our data at ESMO (Free ESMO Whitepaper) 2021 show how we continue to pursue potentially transformative advances in breast and lung cancer, particularly in earlier stage settings where the chance for cure is highest," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "Furthermore our efforts in personalized healthcare, exemplified by our insights in CUP, will help address the needs of many patients who are diagnosed at a late stage."

Breast Cancer Highlights

First Phase II data will be presented from an interim analysis of giredestrant, a next-generation oral selective estrogen receptor degrader, in neoadjuvant, estrogen receptor-positive, HER2-negative early breast cancer. Over 70% of breast cancer cases are hormone receptor (HR)-positive, and there is a need for more effective and tolerable treatments, since up to 30% of patients develop resistance to standard-of-care treatments and in the adjuvant setting half of patients stop treatment due to the toll of side effects. Our efforts in this area represent a step towards making the treatment of patients with HR-positive breast cancer more effective and less debilitating in order to reduce the burden of treatment. This study further showcases Genentech’s commitment to identifying meaningful treatment options for patients with breast cancer through a comprehensive development program that includes early and late-stage HR-positive, HER2-positive and triple-negative forms of the disease.

Lung Cancer Highlights

New results from the Phase III IMpower010 study, to be presented during Presidential Symposium Three, highlight patterns of relapse and subsequent therapy following treatment with Tecentriq (atezolizumab) versus standard of care in early lung cancer, and help to define how Tecentriq fits into the adjuvant treatment pathway. These findings are particularly important as real-world data, which will also be presented at ESMO (Free ESMO Whitepaper), will provide detail on the proportion of people with early non-small cell lung cancer (NSCLC) in the United States who do not receive adjuvant treatment despite guidelines recommending that they do so. These real-world data also highlight survival outcomes in this setting and reinforce the need for more effective adjuvant therapy in NSCLC, as half of all people with early-stage lung cancer today still experience disease recurrence following surgery.

The Phase III IMpower010 study showed adjuvant Tecentriq improved disease-free survival in PD-L1-positive early-stage lung cancer, compared with best supportive care ‒ a first in cancer immunotherapy. Based on the outcomes from this study, the U.S. Food and Drug Administration recently granted Priority Review under the Real-Time Oncology Review pilot program to Tecentriq as an adjuvant treatment for certain people with early NSCLC, and is expected to make a decision later this year.

Innovation in Personalized Healthcare

Latest results from a preliminary descriptive molecular analysis based on the CUPISCO study, which will be featured in the ESMO (Free ESMO Whitepaper) Press Program, shed further light on the genomic profiles of patients with poor-prognosis CUP. These results highlight the importance of comprehensive genomic profiling for patients with CUP and identify therapeutically relevant genomic alterations in a significant proportion of patients, which may help to inform a more personalized treatment plan. In CUP, doctors cannot identify the location of the original (primary) tumor and can only find metastases. This causes practical problems since traditional treatment approaches rely on the site of origin being known, and as such, most patients are treated with nonspecific chemotherapy. Unfortunately, prognosis remains poor and the median survival following diagnosis is just six to 12 months, reinforcing the need for improved diagnosis and treatment.

Real-world data from the United States examining the use of Foundation Medicine’s comprehensive genomic testing prior to first-line therapy in patients with metastatic colorectal cancer will also be presented and underpin Genentech’s efforts to drive more widespread and earlier testing for patients with cancer.

Keep up to date with ESMO (Free ESMO Whitepaper) news and updates by using the hashtag #ESMO21 and follow Genentech on Twitter via @Genentech and on LinkedIn.

Overview of key presentations featuring Genentech medicines

Medicine

Abstract title

Abstract number

Breast cancer

Giredestrant

Neoadjuvant giredestrant (GDC-9545) + palbociclib (palbo) vs anastrozole (A) + palbo in post-menopausal women with oestrogen receptor-positive, HER2-negative, untreated early breast cancer (ER+/HER2– eBC): Interim analysis of the randomised, open-label, phase 2 coopERA BC study

LBA14

Kadcyla

Trastuzumab emtansine (T-DM1) in Asian patients with previously treated HER2-positive locally advanced (LA) or metastatic breast cancer (MBC): data from the phase 3 EMILIA study

284P

Kadcyla

Trial in progress – ASTEFANIA: A phase 3 study of trastuzumab emtansine (T-DM1) plus atezolizumab or placebo as adjuvant therapy in patients with residual invasive breast cancer after neoadjuvant HER2-targeted therapy and chemotherapy

202TiP

Kadcyla

Trial in progress – KATE3: A phase 3 study of trastuzumab emtansine (T-DM1) in combination with atezolizumab or placebo in patients with previously treated HER2-positive and PD-L1–positive locally advanced or metastatic breast cancer

329TiP

Real-world data

Real-world Outcomes of Hormone Receptor-Positive (HR+) HER2-Negative (HER2-) metastatic Breast Cancer (mBC) with High Tumor Mutational Burden (hTMB) Treated with Immune Checkpoint Inhibitors (ICI)

237P

Lung cancer

Tecentriq

IMpower010: Patterns of relapse and subsequent therapy from a Phase III study of atezolizumab (atezo) vs best supportive care (BSC) after adjuvant chemotherapy (chemo) in stage IB-IIIA non-small cell lung cancer (NSCLC)

LBA9

Tiragolumab

Trial in progress – SKYSCRAPER-03: Phase III, Open-Label Randomised Study of Atezolizumab + Tiragolumab vs Durvalumab in Patients with Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (NSCLC) Who Have Not Progressed After Platinum-based Concurrent Chemoradiation (cCRT)

1190TiP

Tecentriq

Atezolizumab (atezo) vs platinum-based chemo in blood-based tumour mutational burden-positive (bTMB+) patients (pts) with first line (1L) advanced/metastatic (m)NSCLC: results of the Blood First Assay Screening Trial (BFAST) Phase 3 Cohort C

1281O

Real-world data

Real-world Adjuvant Treatment Patterns and Survival Outcomes among early NSCLC US Patients

1158P

Real-world data

Adoption and early clinical outcomes of atezolizumab (atezo) + carboplatin and etoposide (CE) in patients with extensive-stage small cell lung cancer (ES-SCLC) in the real-world (RW) setting

1650P

Bladder cancer

Tecentriq

Cisplatin (cis)-related immunomodulation and efficacy with atezolizumab (atezo) + cis- vs carboplatin (carbo)-based chemotherapy (chemo) in metastatic urothelial cancer (mUC)

658MO

Gastric cancer

Tecentriq

Phase Ib/II open-label, randomised evaluation of second-line atezolizumab (atezo) + linagliptin (lina) vs ramucirumab (ram) + paclitaxel (pac) in MORPHEUS-Gastric Cancer

1382P

Head and neck cancer

Tiragolumab

Trial in progress – SKYSCRAPER-09: A Phase II, Randomised, Double-blinded Study of Atezolizumab (Atezo) + Tiragolumab (Tira) and Atezo + Placebo as First-line (1L) Therapy for Recurrent/Metastatic (R/M) PD-L1+ Squamous Cell Carcinoma of the Head and Neck (SCCHN)

927TiP

Hepatocellular carcinoma

Tecentriq

IMbrave150: exploratory efficacy and safety results in patients with hepatocellular carcinoma without macrovascular invasion (MVI) or extrahepatic spread (EHS) treated with atezolizumab (atezo) + bevacizumab (bev) or sorafenib (sor)

932P

Tumor agnostic treatment and personalized healthcare

Comprehensive genomic profiling

Baseline mutational profiles of patients (pts) with carcinoma-of-unknown-primary-origin (CUP) enrolled onto CUPISCO

1804P

Comprehensive genomic profiling

Fusion and rearrangement (RE) detection using DNA and RNA-based comprehensive genomic profiling (CGP) of sarcomas

1532P

Comprehensive genomic profiling

Circulating tumor DNA (ctDNA) from patients (pts) with advanced colorectal cancer (CRC) is enriched for EGFR extracellular domain (ECD) mutations

457P

Tumor agnostic

Blood tumor mutational burden (bTMB) and efficacy of immune checkpoint inhibitors (ICIs) in advanced solid tumors: SCRUM-Japan MONSTAR-SCREEN

80P

Real-world data

Comprehensive genomic profiling (CGP) and PD-L1 IHC in patients (pts) with advanced non-small cell lung cancer (aNSCLC): Testing and Treatment Patterns in the real-world (RW) setting

1301P

Real-world data

Utilisation and predictors of genomic testing prior to first-line (1L) therapy in patients (pts) with metastatic colorectal cancer (mCRC)

477P

About Tecentriq (atezolizumab)

Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumor cells and tumor-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.

Tecentriq U.S. Indications

Tecentriq is a prescription medicine used to treat adults with:

A type of bladder and urinary tract cancer called urothelial carcinoma.

Tecentriq may be used in patients with urothelial carcinoma if their bladder cancer has spread or cannot be removed by surgery, and if they have any one of the following conditions:

They are not able to take chemotherapy that contains a medicine called cisplatin and their cancer tests positive for "PD-L1" or
They are not able to take chemotherapy that contains any platinum regardless of the levels of "PD-L1" status
The approval of Tecentriq in these patients is based on a study that measured the amount of time until patients’ disease worsened. Continued approval for this use may depend on the results of an ongoing study to confirm benefit.

A type of lung cancer called non-small cell lung cancer (NSCLC).

Tecentriq may be used alone as the first treatment in patients with lung cancer if:

Their cancer has spread or grown, and
Their cancer tests positive for "high PD-L1" and
Their tumor does not have an abnormal "EGFR" or "ALK" gene.
Tecentriq may be used with the medicines bevacizumab, paclitaxel, and carboplatin as the first treatment in patients with lung cancer if:

Their cancer has spread or grown and
Is a type of lung cancer called "non-squamous NSCLC" and
Their tumor does not have an abnormal "EGFR" or "ALK" gene
Tecentriq may be used with the medicines paclitaxel protein-bound and carboplatin as the first treatment in patients with lung cancer if:

Their cancer has spread or grown and
Is a type of lung cancer called "non-squamous NSCLC" and
Their tumor does not have an abnormal "EGFR" or "ALK" gene
Tecentriq may be used alone in patients with lung cancer if:

Their cancer has spread or grown and
They have tried chemotherapy that contains platinum, and it did not work or is no longer working
If a patient’s tumor has an abnormal EGFR or ALK gene, they should have also tried an FDA-approved therapy for tumors with these abnormal genes, and it did not work or is no longer working.
A type of breast cancer called triple-negative breast cancer (TNBC).

Tecentriq may be used with the medicine paclitaxel protein-bound in patients with TNBC when their breast cancer:

Has spread or cannot be removed by surgery and
Their cancer tests positive for "PD-L1"
The approval of Tecentriq in these patients is based on a study that measured the amount of time until patients’ disease worsened. Continued approval for this use may depend on the results of an ongoing study to confirm benefit.

Tecentriq is not for use with the medicine paclitaxel (a different medicine than paclitaxel protein-bound) in patients with TNBC when their breast cancer has spread or cannot be removed by surgery.

A type of lung cancer called small cell lung cancer (SCLC).

Tecentriq may be used with the chemotherapy medicines carboplatin and etoposide as the first treatment in patients with SCLC when their lung cancer:

is a type called "extensive-stage small cell lung cancer," which means that it has spread or grown.
A type of liver cancer called hepatocellular carcinoma (HCC).

Tecentriq may be used with the medicine bevacizumab in patients with HCC if:

Their cancer has spread or cannot be removed by surgery, and
They have not received other medicines by mouth or injection through their vein (IV) to treat their cancer.
A type of skin cancer called melanoma.

Tecentriq may be used with the medicines cobimetinib and vemurafenib when in patients with melanoma when their skin cancer:

has spread to other parts of the body or cannot be removed by surgery, and
has a certain type of abnormal "BRAF" gene.
Healthcare providers will perform a test to make sure this Tecentriq combination is right for the patient.

It is not known if Tecentriq is safe and effective in children.

Important Safety Information

The most important information about Tecentriq is:

Tecentriq can cause the immune system to attack normal organs and tissues and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death. Patients can have more than one of these problems at the same time. These problems may happen anytime during treatment or even after treatment has ended.

Patients should call or see their healthcare provider right away if they get any symptoms of the following problems or these symptoms get worse.

Lung problems

Cough
Shortness of breath
Chest pain
Intestinal problems

Diarrhea (loose stools) or more bowel movements than usual
Blood or mucus in stools or dark, tarry, sticky stools
Severe stomach area (abdomen) pain or tenderness
Liver problems

Yellowing of the skin or the whites of the eyes
Severe nausea or vomiting
Pain on the right side of the stomach area (abdomen)
Drowsiness, dark urine (tea-colored)
Bleeding or bruising more easily than normal and feeling less hungry than usual
Hormone gland problems

Headaches that will not go away or unusual headaches
Eye sensitivity to light
Eye problems
Rapid heartbeat
Increased sweating
Extreme tiredness
Weight gain or weight loss
Feeling more hungry or thirsty than usual
Urinating more often than usual
Hair loss
Feeling cold
Constipation
The voice gets deeper
Dizziness or fainting
Changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
Kidney problems

Urinating less than usual
Blood in the urine
Swelling of ankles
Loss of appetite
Skin problems

Rash
Itching
Skin blistering or peeling
Painful sores or ulcers in mouth or nose, throat, or genital area
Fever or flu-like symptoms
Swollen lymph nodes
Problems can also happen in other organs.

These are not all of the signs and symptoms of immune system problems that can happen with Tecentriq. Patients should call or see their healthcare provider right away for any new or worse signs or symptoms, including:

Chest pain, irregular heartbeat, shortness of breath, or swelling of ankles
Confusion, sleepiness, memory problems, changes in mood or behavior, stiff neck, balance problems, tingling or numbness of the arms or legs
Double vision, blurry vision, sensitivity to light, eye pain, changes in eyesight
Persistent or severe muscle pain or weakness, muscle cramps
Low red blood cells, bruising
Infusion reactions that can sometimes be severe or life-threatening. Signs and symptoms of infusion reactions may include:

Chills or shaking
Itching or rash
Flushing
Shortness of breath or wheezing
Dizziness
Feeling like passing out
Fever
Back or neck pain
Complications, including graft-versus-host disease (GVHD), in people who have received a bone marrow (stem cell) transplant that uses donor stem cells (allogeneic).

These complications can be serious and can lead to death. These complications may happen if a patient underwent transplantation either before or after being treated with Tecentriq. A patient’s healthcare provider will monitor them for these complications.

Getting medical treatment right away may help keep these problems from becoming more serious. A healthcare provider will check patients for these problems during their treatment with Tecentriq. A healthcare provider may treat patients with corticosteroid or hormone replacement medicines. A healthcare provider may delay or completely stop treatment with Tecentriq if patients have severe side effects.

Before receiving Tecentriq, patients should tell their healthcare provider about all of their medical conditions, including if they:

Have immune system problems (such as Crohn’s disease, ulcerative colitis, or lupus)
Have had an organ transplant
Have received or plan to receive a stem cell transplant that uses donor stem cells (allogeneic)
Have received radiation treatment to their chest area
Have a condition that affects the nervous system (such as myasthenia gravis or Guillain-Barre syndrome
Are pregnant or plan to become pregnant. Tecentriq can harm an unborn baby.
Patients should tell their healthcare provider right away if they become pregnant or think they may be pregnant during treatment with Tecentriq.
Females who are able to become pregnant:
Should have a healthcare provider do a pregnancy test before they start treatment with Tecentriq and
Should use an effective method of birth control during their treatment and for at least 5 months after the last dose of Tecentriq
Are breastfeeding or plan to breastfeed. It is not known if Tecentriq passes into breast milk. Patients should not breastfeed during treatment and for at least 5 months after the last dose of Tecentriq
The most common side effects of Tecentriq when used alone include:

Feeling tired or weak
Nausea
Cough
Shortness of breath
Decreased appetite
The most common side effects of Tecentriq when used in lung cancer with other anti-cancer medicines include:

Feeling tired or weak
Nausea
Hair loss
Constipation
Diarrhea
Decreased appetite
The most common side effects of Tecentriq when used in TNBC with paclitaxel protein-bound include:

A decrease in hemoglobin (anemia)
Decreased white blood cells
Hair loss
Tingling or numbness in hands and feet
Feeling tired
Nausea
Diarrhea
Constipation
Cough
Headache
Vomiting
Decreased appetite
The most common side effects of Tecentriq when used in hepatocellular carcinoma (HCC) with bevacizumab include:

High blood pressure
Feeling tired or weak
Too much protein in the urine
The most common side effects of Tecentriq when used in melanoma with cobimetinib and vemurafenib include:

Skin rash
Joint, muscle, or bone pain
Feeling tired or weak
Liver injury
Fever
Nausea
Itching
Swelling of legs or arms
Mouth swelling (sometimes with sores)
Low thyroid hormone levels
Sunburn or sun sensitivity
Tecentriq may cause fertility problems in females, which may affect their ability to have children. Patients should talk to their healthcare provider if they have concerns about fertility.

These are not all the possible side effects of Tecentriq. Patients should ask their healthcare provider or pharmacist for more information. Patients should call their doctor for medical advice about side effects of Tecentriq.

Report side effects to the FDA at (800) FDA-1088 or View Source Report side effects to Genentech at (888) 835-2555.