On May 19, 2021 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that it will present new research data for its three lead DXd antibody drug conjugates (ADCs) in multiple types of cancer at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) (#ASCO21) Virtual Scientific Program to be held June 4 to 8, 2021 (Press release, Daiichi Sankyo, MAY 19, 2021, https://www.businesswire.com/news/home/20210519005576/en/Daiichi-Sankyo-Advances-Science-Across-Three-Lead-DXd-ADCs-with-New-Data-in-Multiple-Cancers-at-2021-ASCO-Virtual-Meeting [SID1234580306]).

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

                  Schedule Your 30 min Free Demo!

Presentations will highlight the company’s growing leadership in developing multiple potential treatment approaches for cancer including an oral presentation featuring extended follow-up data from a phase 1 trial of patritumab deruxtecan (HER3-DXd) in patients with locally advanced or metastatic TKI-resistant, EGFR-mutated non-small cell lung cancer (NSCLC). Preliminary data from this trial informed the recently initiated pivotal HERTHENA-Lung01 phase 2 trial. Additionally, a dose analysis from the NSCLC cohort of the TROPION-PanTumor01 trial, which formed the basis of the datopotamab deruxtecan (Dato-DXd) dose being evaluated in the pivotal TROPION-Lung01 phase 3 trial, will be presented.

Final overall survival results from the pivotal DESTINY-Gastric01 phase 2 trial and final results from the DESTINY-CRC01 phase 2 trial of ENHERTU (trastuzumab deruxtecan) also will be featured. ENHERTU was recently highlighted in the Clinical Cancer Advances 2021 report as one of two significant advancements in the "ASCO Clinical Advance of the Year: Molecular Profiling Driving Progress in GI Cancers," based on data from both DESTINY-Gastric01 and DESTINY-CRC01.

"The data being presented at ASCO (Free ASCO Whitepaper) showcase Daiichi Sankyo’s sustained progress in advancing our three lead DXd ADCs across multiple cancers including lung, breast, gastric and colorectal cancers," said Ken Takeshita, MD, Global Head, Research and Development, Daiichi Sankyo. "All of these new data, biomarker research and trial-in-progress updates demonstrate our commitment to translating our innovative science and technology into potential treatment options for patients with cancer."

Additional ENHERTU data to be highlighted at ASCO (Free ASCO Whitepaper) includes updated subgroup analysis of the pivotal DESTINY-Breast01 trial in patients with metastatic HER2 positive breast cancer and brain metastases, initial results from the ENHERTU arm of the BEGONIA phase 1b/2 durvalumab combination trial in patients with triple negative breast cancer (TNBC), and pooled subgroup analysis across two phase 1 studies of patients with HER2 expressing salivary gland cancer.

Daiichi Sankyo will hold two ASCO (Free ASCO Whitepaper) conference calls for investors and analysts on Monday, June 7, 2021 from 6:30 PM-8:00 PM EDT (investors located in Japan) and on Tuesday, June 8, 2021 from 7:00 AM-8:30 AM EDT (investors located outside of Japan). Company executives will provide an overview of the ASCO (Free ASCO Whitepaper) research data, updates for the oncology portfolio and address questions from investors and analysts.

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

Presentation Title

Author

Abstract

Presentation Details

Patritumab deruxtecan (HER3-DXd)

NSCLC

Efficacy and safety of patritumab deruxtecan (HER3-DXd) in EGFR inhibitor–resistant, EGFR-mutated non-small cell lung cancer (NSCLC)

P. Jänne

9007

Oral Presentation

Lung Cancer – Non-Small Cell Metastatic: Friday, June 4, 2021; 1:00 – 4:00 PM EDT

A randomized phase 2 study of patritumab deruxtecan (U3-1402) in patients with previously treated metastatic or locally advanced EGFR-mutated NSCLC

P. Jänne

TPS9139

Poster Presentation

Datopotamab deruxtecan (Dato-DXd)

NSCLC

TROPION-PanTumor01: dose analysis of the TROP2 directed antibody-drug conjugate (ADC) datopotamab deruxtecan (Dato-DXd; DS-1062) for the treatment of advanced or metastatic non-small cell lung cancer

F. Meric-Bernstam

9058

Poster Presentation

A randomized, phase 3 study of datopotamab deruxtecan (Dato-DXd; DS-1062) vs docetaxel in previously treated advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations (TROPION-Lung01)

K. Yoh

TPS9127

Poster Presentation

Breast

BEGONIA: phase 1b/2, open-label, platform study of the safety and efficacy of durvalumab (D) ± paclitaxel (P) with novel oncology therapies for first-line metastatic triple-negative breast cancer (mTNBC): addition of Arm 7, D + datopotamab deruxtecan (Dato-DXd; DS-1062)

P. Schmid

TPS1105

Poster Presentation

ENHERTU (trastuzumab deruxtecan; T-DXd)

Colorectal

Trastuzumab deruxtecan (T-DXd; DS-8201) in patients with HER2 expressing metastatic colorectal cancer (mCRC): final results from a phase 2, multicenter, open-label study (DESTINY-CRC01)

T. Yoshino

3505

Oral Presentation

Gastrointestinal Cancer – Colorecal and Anal: Monday, June 7; 1:15 – 4:15 PM EDT

Trastuzumab deruxtecan in patients with HER2 overexpressing locally advanced, unresectable, or metastatic colorectal cancer (mCRC): a randomized, multicenter, phase 2 study (DESTINY-CRC02)

K. Raghav

TPS3620

Poster Presentation

Gastric

Trastuzumab deruxtecan (T-DXd; DS-8201) in patients with HER2 positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma: final overall survival (OS) results from a randomized, multicenter, open-label, phase 2 study (DESTINY-Gastric01)

K. Yamaguchi

4048

Poster Presentation

Quality-adjusted time without symptoms or toxicity (Q-TWiST) of trastuzumab deruxtecan (T-DXd) versus chemotherapy in patients with advanced gastric cancer from the DESTINY-Gastric01trial

D. Cella

4057

Poster Presentation

Breast

Trastuzumab deruxtecan (T-DXd) in patients with HER2+ metastatic breast cancer with brain metastases: a subgroup analysis of the DESTINY-Breast01 trial

G. Jerusalem

526

Poster Presentation

BEGONIA: phase 1b/2 study of durvalumab (D) combinations in locally advanced/metastatic triple negative breast cancer (TNBC): Initial results from Arm 1, D+paclitaxel (P), and Arm 6, D+trastuzumab deruxtecan

P. Schmid

1023

Poster Discussion Session

Trastuzumab deruxtecan (T-DXd) combinations in patients with HER2 positive advanced or metastatic breast cancer: a phase 1b/2, open-label, multicenter, dose-finding and dose-expansion study (DESTINY-Breast07)

F. Andre

TPS1096

Poster Presentation

Prevalence of HER2 low in breast cancer subtypes using the VENTANA anti-HER2/neu (4B5) assay

M. Scott

1021

Poster Discussion Session

Machine learning models to quantify HER2 for real-time tissue image analysis in prospective clinical trials

B.Glass

3061

Poster Presentation

Pan Tumor

Trastuzumab deruxtecan (T-DXd) in patients with human epidermal growth factor receptor 2 (HER2)-expressing salivary duct carcinoma: Subgroup analysis of two phase 1 studies

H. Bando

6079

Poster Presentation

A phase 2, multicenter, open-label study evaluating trastuzumab deruxtecan (T-DXd) for the treatment of solid tumors harboring specific HER2 activating mutations (DESTINY-PanTumor01)

B.Li

TPS3162

Poster Presentation

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 research 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 under accelerated approval in the U.S, under conditional marketing authorization in the EU and the UK, and under the conditional early approval system in Japan 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 the U.S. and Japan 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 accompanying full Prescribing Information, including Boxed WARNINGS, and Medication Guide.

Patritumab deruxtecan, datopotamab 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.

On May 19, 2021 Gilead Sciences, Inc. (Nasdaq: GILD) and Kite, a Gilead Company, reported that 16 abstracts representing the breadth of the Gilead-Kite Oncology portfolio will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 4-8, 2021 (Press release, Gilead Sciences, MAY 19, 2021, View Source [SID1234580305]). The abstracts, including two oral presentations, expand on the clinical profiles of Gilead’s antibody-drug conjugate (ADC), as well as Kite’s chimeric antigen receptor (CAR) T-cell therapies across a range of cancers, including in existing indications and for investigational uses.

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

                  Schedule Your 30 min Free Demo!

"Gilead-Kite Oncology is rapidly advancing transformative science for people facing historically difficult-to-treat cancers," said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. "Our first-in-class, TROP-2 directed ADC therapy is already having a meaningful impact for people with metastatic triple-negative breast and urothelial cancers, and data at ASCO (Free ASCO Whitepaper) will add further insight into its utility in TNBC in both monotherapy and future combination treatment approaches."

"CAR T-cell therapy has changed the lives of patients suffering from certain forms of non-Hodgkin lymphoma, and our data at ASCO (Free ASCO Whitepaper) demonstrate important progress in extending the benefits to more patients in need," said Frank Neumann, MD, PhD, Kite’s Global Head of Clinical Development. "As we aim to bring CAR T to people with many different hematologic malignancies, we are just beginning to scratch the surface of what is possible."

A list of accepted abstracts follows here:

Abstract Disposition

Abstract Title

Gilead Presentations

Oral #1011

6:00 am PT/9:00 am ET

Outcomes in Patients Aged ≥65 Years in the Phase 3 ASCENT Study of Sacituzumab Govitecan (SG) in Metastatic Triple-Negative Breast Cancer (mTNBC)

Poster #1077

Assessment of Sacituzumab Govitecan (SG) versus Treatment of Physician’s Choice (TPC) Cohort by Agent in the Phase 3 ASCENT Study of Patients with Metastatic Triple-Negative Breast Cancer (mTNBC)

Poster #1080

Assessment of Sacituzumab Govitecan (SG) in Patients with Prior Neoadjuvant/Adjuvant Chemotherapy in the Phase 3 ASCENT Study in Metastatic Triple-Negative Breast Cancer (mTNBC)

Poster #TPS602

Phase 3 Postneoadjuvant Study Evaluating Sacituzumab Govitecan, an Antibody Drug Conjugate in Primary HER2-Negative Breast Cancer Patients with High Relapse Risk After Standard Neoadjuvant Treatment – SASCIA

Poster #TPS1102

Saci-IO HR+: Randomized Phase 2 Trial of Sacituzumab Govitecan (SG) +/- Pembrolizumab in PD-L1+ Hormone Receptor-Positive (HR+) / HER2- Metastatic Breast Cancer (MBC)

Poster #TPS1106

Saci-IO TNBC: Randomized Phase 2 Trial of Sacituzumab Govitecan (SG) +/- Pembrolizumab in PD-L1– Metastatic Triple-Negative Breast Cancer (mTNBC)

Poster #TPS7055

Magrolimab + Azacitidine versus Azacitidine + Placebo in Untreated Higher Risk Myelodysplastic Syndrome (MDS): The Phase 3, Randomized, ENHANCE Study

Poster #2559

GS-3583, a Novel FLT3 Agonist Fc Fusion Protein, to Expand Conventional Dendritic Cells in Healthy Volunteers

Poster #TPS3147

Phase 1b Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of GS-3583, a FLT3 Agonist Fc Fusion Protein, in Patients with Advanced Solid Tumors

Kite Presentations

Oral #7002

11:30 am PT/2:30 pm ET

Phase 2 Results of the ZUMA-3 Study Evaluating KTE-X19, an Anti-CD19 Chimeric Antigen Receptor (CAR) T-Cell Therapy, in Adult Patients with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia (R/R B-ALL)

Poster #7515

Outcomes in ZUMA-5 with Axicabtagene Ciloleucel (Axi-Cel) in Patients with Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (iNHL) Who Had the High-Risk Feature of Progression within 24 Months from Initiation of First Anti-CD20–Containing Chemoimmunotherapy (POD24)

Poster #7536

Favorable Tumor Immune Microenvironment (TME) and Robust Chimeric Antigen Receptor (CAR) T-Cell Expansion May Overcome Tumor Burden and Promote Durable Efficacy with Axicabtagene Ciloleucel (Axi-Cel) in Large B Cell Lymphoma (LBCL)

Poster #7547

Outcomes with KTE-X19 in Patients with Relapsed/Refractory Mantle Cell Lymphoma (MCL) in ZUMA-2 Who Had Progression of Disease within 24 Months of Diagnosis (POD24)

Poster #7548

Updated Outcomes with Axicabtagene Ciloleucel (Axi-Cel) Retreatment in Patients with Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (iNHL) in ZUMA-5

Poster #7552

Real-World Evidence of Axicabtagene Ciloleucel (Axi-Cel) for the Treatment of Large B-Cell Lymphoma (LBCL) in the United States

Poster #e19548

Online Publication Only

Clinical Outcomes in Patients Relapsed/Refractory After ≥ 2 Prior Lines of Therapy for Follicular Lymphoma: A Systematic Literature Review and Meta-Analysis

All poster presentations will be made available on-demand beginning Friday, June 4 at 6:00 am PT/9:00 am ET.

For more information, including a complete list of abstract titles at the meeting, please visit: View Source

On May 19, 2021 Jasper Therapeutics, Inc., a biotechnology company focused on hematopoietic cell transplant therapies, reported updated 90-day efficacy, safety and pharmacokinetic data from its ongoing multicenter Phase 1 clinical trial of JSP191, the company’s first-in-class anti-CD117 monoclonal antibody, as a targeted, non-toxic conditioning regimen in older patients with myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML) undergoing allogeneic hematopoietic (blood) cell transplantation (Press release, Jasper Therapeutics, MAY 19, 2021, View Source [SID1234580304]). Data from the dose-finding part of the study showed that conditioning with a single dose of JSP191 0.6 mg/kg prior to low dose radiation and fludarabine in preparation for transplantation was well tolerated in all six patients and led to successful transplant as evidenced by full chimerism and elimination of measurable residual disease (MRD) in five of six patients. The findings will be presented by lead investigator Lori Muffly, M.D., M.S., Assistant Professor of Medicine (Blood and Bone Marrow Transplantation) at Stanford Medicine, in a poster session at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which is being held online from June 4-8. The abstract is available now on the ASCO (Free ASCO Whitepaper) Annual Meeting website.

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

                  Schedule Your 30 min Free Demo!

"We are very encouraged by the updated efficacy and safety results from this Phase 1 clinical study, which is the first to evaluate JSP191 in combination with non-myeloablative conditioning for older patients with MDS or AML. These data are consistent with pre-clinical work that demonstrated the capacity of JSP191 to target myelodysplastic cells and synergize with low doses of radiation. While hematopoietic cell transplantation is curative in these patients, its use is limited in older and frail patients because of the toxicity associated with standard-of-care myeloablative conditioning agents," said Kevin N. Heller, M.D., Executive Vice President, Research and Development, of Jasper Therapeutics. "Based on this data and feedback from the FDA, we have now opened the dose-expansion phase of the study at the recommended Phase 2 dose. We anticipate announcing topline data in the first half of next year. We continue to evaluate JSP191 as a conditioning agent in multiple additional diseases, including our ongoing clinical trial in severe combined immunodeficiency (SCID), our upcoming study in refractory autoimmune disease and with our partnerships with the NIH and Stanford in sickle cell disease and Fanconi anemia. We believe that JSP191 addresses key limitations of current conditioning regimens and potentially may expand the number of patients with devastating diseases who could be cured with hematopoietic stem cell therapy."

At 90 days after transplant, MRD as measured by cytogenetics, karyotype and next-generation sequencing was negative (undetected) in five patients and reduced in one patient, and full chimerism (greater than 95%) was observed in five of the six patients. One patient had secondary graft failure with no evidence of relapse at 90 days. JSP191, when added to low-dose radiation and fludarabine, was well tolerated in all six patients; the protocol allows for subjects to receive the conditioning regimen in an outpatient setting. No infusion reactions, treatment-related toxicities such as oral mucositis or evidence of acute graft versus host disease were reported. Pharmacokinetic data showed that serum levels of the JSP191 0.6 mg/kg dose were consistent among study participants as evaluated up to 14 days post-infusion.

Phase 1 Study Design

The open-label, multicenter Phase 1 study (JSP-CP-003) is evaluating the safety, tolerability and efficacy of adding JSP191 to the standard conditioning regimen of low-dose radiation and fludarabine among patients age 65 to 74 years with MDS or AML undergoing hematopoietic cell transplantation. Patients were ineligible for full myeloablative conditioning. The primary outcome measure of the study is the safety and tolerability of JSP191 as a conditioning regimen up to one year following a donor cell transplant. Secondary endpoints include engraftment and donor chimerism, MRD clearance, non-relapse mortality, event-free survival and overall survival.

About MDS and AML

Myelodysplastic syndromes (MDS) are a group of disorders in which immature blood-forming cells in the bone marrow become abnormal and do not make new blood cells or make defective blood cells, leading to low numbers of normal blood cells, especially red blood cells.i In about one in three patients, MDS can progress to acute myeloid leukemia (AML), a rapidly progressing cancer of the bone marrow cells.i Both are diseases of the elderly with high mortality. Each year, about 29,000 patients are diagnosed with MDS and approximately 42,000 patients are diagnosed with AML in the G7 countries for which approximately 2,500 patients with MDS and approximately 8,000 people with AML receive hematopoietic stem cell transplants. These transplants are curative but are underused due to the toxicity of the current high-intensity conditioning regimen, which includes the chemotherapy agents busulfan and fludarabine.

About JSP191

JSP191 is a first-in-class humanized monoclonal antibody in clinical development as a conditioning agent that blocks stem cell factor receptor signaling leading to clearance of hematopoietic stem cells from bone marrow, creating an empty space for donor or gene-corrected transplanted stem cells to engraft. To date, JSP191 has been evaluated in more than 90 healthy volunteers and patients. Jasper is currently enrolling in two clinical trials for acute myeloid leukemia (AML)/myelodysplastic syndromes (MDS) and severe combined immunodeficiency (SCID) and expects to begin enrollment in three additional studies in 2021 for severe autoimmune disease, sickle cell disease and Fanconi anemia patients undergoing hematopoietic cell transplantation.

On May 19, 2021 ImmunoGen Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported mature data from the FORWARD II study evaluating mirvetuximab soravtansine in combination with Avastin (bevacizumab) in patients with medium and high folate receptor alpha (FRα)-expressing recurrent ovarian cancer for whom a non-platinum based combination regimen is appropriate (Press release, ImmunoGen, MAY 19, 2021, View Source [SID1234580303]). These findings will be highlighted in an oral presentation at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Annual Meeting, which is being held June 4-8, 2021. Two posters highlighting mirvetuximab combination regimens will also be presented by ImmunoGen’s collaborators during the meeting.

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

                  Schedule Your 30 min Free Demo!

"Due to the introduction of effective maintenance therapies, patients with recurrent ovarian cancer are living longer and comprise an increasing population in need of effective, well-tolerated non-platinum based regimens," said Anna Berkenblit, MD, Senior Vice President and Chief Medical Officer of ImmunoGen. "With a 64% ORR, 11.8 month mDOR, and 10.6 month mPFS, the combination of mirvetuximab plus bevacizumab shows compelling activity in patients with high FRα recurrent ovarian cancer. We are extremely pleased to present these data during an oral presentation at ASCO (Free ASCO Whitepaper), as they build on previous findings and provide us with further evidence of mirvetuximab’s potential to become the combination agent of choice for ovarian cancer patients."

MATURE DATA FROM FORWARD II DOUBLET COHORT WITH BEVACIZUMAB

The cohort enrolled 60 patients with a median age of 60 and a median number of 2 prior lines of therapy (range 1-4). 53% had platinum-resistant disease with a platinum-free interval (PFI) of less than or equal to 6 months; 33% had partially platinum-sensitive disease with a PFI greater than 6 months and less than or equal to 12 months; and 13% had a PFI greater than 12 months. 40% of patients in the cohort were previously treated with bevacizumab and 35% of patients in the cohort were previously treated with a PARP inhibitor. The combination of mirvetuximab with bevacizumab in this cohort demonstrates promising anti-tumor activity with a favorable tolerability profile, particularly among patients with high levels of FRα expression, and is encouraging relative to outcomes with available therapies reported in similar populations. In the oral presentation, key updated data include:

In the overall patient population, objective responses were seen in 30 patients and the confirmed overall response rate (ORR) was 50% (95% CI, 34, 60), with a median duration of response (mDOR) of 9.7 months (95% CI 6.7, 12.9) and median progression-free survival (mPFS) of 8.3 months (95% CI 5.6, 10.1).
In patients with high FRα expression (n=33), the confirmed ORR was 64% (95% CI, 45, 80), mDOR was 11.8 months (95% CI 6.7, 13.7), and mPFS was 10.6 months (95% CI 8.3, 13.3).
In high FRα platinum-sensitive patients, who represent a growing population, the combination of mirvetuximab plus bevacizumab achieved a 69% ORR, 12.7 month mDOR, and a 13.3 month mPFS.
In high FRα platinum-resistant patients, the combination of mirvetuximab plus bevacizumab achieved a 59% ORR, 9.4 month mDOR, and a 9.7 month mPFS.
The adverse events (AEs) observed with the doublet were manageable and consistent with the side effect profiles of each agent. Treatment-related AEs were generally low grade, with diarrhea (62%), blurred vision (60%), fatigue (60%), and nausea (57%) being the most common. The most common grade 3+ events were hypertension (17%) and neutropenia (13%).
"Despite advances in the maintenance setting of ovarian cancer, a high unmet need for novel, well-tolerated, targeted treatments exists in those patients with recurrent high-grade epithelial ovarian cancer," said David O’Malley, MD, Professor, Director of Gynecologic Oncology and Co-Director, Gynecologic Oncology Phase 1 Program at The Ohio State University and the James Cancer Center, and FORWARD II Principal Investigator. "The data we continue to see when mirvetuximab is combined with bevacizumab in recurrent disease are extremely encouraging, particularly in light of outcomes reported with available therapies in even less heavily pre-treated populations. The strength of these mature data warrant further development of this novel, targeted combination and I look forward to evaluating this regimen in earlier lines of therapy."

ORAL PRESENTATION SESSION

Title: "Mirvetuximab Soravtansine, a Folate Receptor Alpha-Targeting Antibody-Drug Conjugate, in Combination with Bevacizumab in Patients with Platinum-Agnostic Ovarian Cancer – Final Analysis"
Day/Time: Monday, June 7 from 8:00 a.m. to 11:00 a.m. ET
Lead Author: David M. O’Malley, MD, The Ohio State University College of Medicine
Abstract: 5504
POSTER SESSIONS

The following posters will be available on Friday, June 4 at 9:00 a.m. ET in the ASCO (Free ASCO Whitepaper) Meeting Library:

Title: "A Phase I Study of Mirvetuximab Soravtansine and Gemcitabine in Patients with FRα-Positive Solid Tumors: Results from the Ovarian Cancer Cohort"
Lead Author: Mihaela C. Cristea, MD, City of Hope National Medical Center
Abstract: 5542
Title: "A Phase 2, Two-Stage Study of Mirvetuximab Soravtansine in Combination with Pembrolizumab in Patients with Microsatellite Stable Endometrial Cancer"
Lead Author: Rebecca L. Porter, MD, PhD, Dana-Farber Cancer Institute
Abstract: TPS5611
Additional information can be found at www.asco.org.

ABOUT MIRVETUXIMAB SORAVTANSINE

Mirvetuximab soravtansine (IMGN853) is a first-in-class ADC comprising a folate receptor alpha (FRα)-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin-targeting agent, to kill the targeted cancer cells.

ABOUT FORWARD II

FORWARD II is a Phase 1b/2 study of mirvetuximab soravtansine in combination with Avastin (bevacizumab), carboplatin, or Keytruda (pembrolizumab) in patients with FRα-positive recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancers, as well as a triplet combination of mirvetuximab plus carboplatin and bevacizumab in patients with FRα-positive platinum-sensitive ovarian cancer.

On May 19, 2021 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported interim results from the Phase III IMpower010 study, showing for the first time that treatment with Tecentriq (atezolizumab) following surgery and chemotherapy reduced the risk of disease recurrence or death (disease-free survival; DFS) by 34% (hazard ratio [HR]=0.66, 95% CI: 0.50-0.88) in people with Stage II-IIIA non-small cell lung cancer (NSCLC), whose tumors express PD-L1≥1%, compared with best supportive care (BSC) (Press release, Genentech, MAY 19, 2021, View Source [SID1234580302]). In this population, median DFS was not yet reached for Tecentriq compared with 35.3 months for BSC.

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

                  Schedule Your 30 min Free Demo!

In the larger population of all randomized Stage II-IIIA study participants, Tecentriq reduced the risk of disease recurrence or death by 21% (HR=0.79, 95% CI: 0.64-0.96) after a median follow-up of 32.2 months. In this population, Tecentriq increased DFS by a median of seven months (42.3 months vs. 35.3 months with BSC). Safety data for Tecentriq were consistent with its known safety profile and no new safety signals were identified. The full results of IMpower010 will be presented in the lung cancer oral abstract session (Abstract #8500) on Sunday, June 6 (8:00 AM – 11:00 AM EDT) at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting.

"These landmark Phase III data demonstrate for the first time that cancer immunotherapy can bring a clinically meaningful improvement to certain people with early lung cancer in the adjuvant setting," said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. "These results lay the groundwork for a new approach to the treatment of early-stage lung cancer and bring us closer to our goal of providing an effective and tailored treatment option for every person diagnosed with this disease."

The goal of adjuvant therapy is to lower the risk of recurrence and provide the best opportunity for a cure. Still, about half of all patients with Stage I-III NSCLC eventually develop disease recurrence following curative-intent treatment. Adjuvant platinum-based chemotherapy is the current standard of care for patients with completely resected early-stage NSCLC (Stage IB-IIIA) who are at a high-risk of disease recurrence or relapse. This treatment provides a modest 4-5% improvement in five-year survival compared with observation.

Follow-up will continue with planned analyses of DFS in the overall intent-to-treat (ITT) population, including Stage IB patients, which at the time of analysis did not cross the threshold, and overall survival (OS) data, which were immature at the time of interim analysis. In the overall randomized population of study participants, adverse events (AEs) occurred in 92.7% of people receiving Tecentriq, compared with 70.7% of those receiving BSC. Grade 3 or 4 events occurred in 21.8% of people treated with Tecentriq compared with 11.5% in the BSC group; 0.8% of people in the Tecentriq group experienced a Grade 5 AE. As anticipated, the addition of up to one year of Tecentriq following chemotherapy led to a higher number of AEs compared with BSC.

Tecentriq has previously shown clinically meaningful benefit in various types of lung cancer, with five currently approved indications in the U.S. It was the first approved cancer immunotherapy for front-line treatment of adults with extensive-stage small cell lung cancer in combination with carboplatin and etoposide (chemotherapy). Tecentriq also has four approved indications in NSCLC as either a single agent or in combination with targeted therapies and/or chemotherapies. Tecentriq is available in three dosing options, providing the flexibility to choose administration every two, three or four weeks.

Genentech has an extensive development program for Tecentriq, including multiple ongoing and planned Phase III studies across different settings in lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines, as well as studies in metastatic, adjuvant and neoadjuvant settings across various tumor types.

About the IMpower010 study

IMpower010 is a Phase III, global, multicenter, open-label, randomized study evaluating the efficacy and safety of Tecentriq compared with BSC, in participants with Stage IB-IIIA NSCLC (UICC 7th edition), following surgical resection and up to 4 cycles of adjuvant cisplatin-based chemotherapy. The study randomized 1,005 people with a ratio of 1:1 to receive either at most 16 cycles of Tecentriq or BSC. The primary endpoint is investigator-determined DFS in the PD-L1-positive Stage II-IIIA, all randomized Stage II-IIIA and ITT Stage IB-IIIA populations. Key secondary endpoints include OS in the overall study population, ITT Stage IB-IIIA NSCLC.

Efficacy results

PD-L1≥1% Stage II-IIIA

Randomized Stage II-IIIA

ITT

Tecentriq (n=248)

BSC (n=228)

Tecentriq (n=442)

BSC (n=440)

Tecentriq (n=507)

BSC (n=498)

Median DFS (months)

NR

35.3

42.3

35.3

NR

37.2

Stratified HR (95% CI)

0.66 (0.50, 0.88)

0.79 (0.64, 0.96)

0.81 (0.67, 0.99)*

Stratified Log-rank p-value (2-sided)

0.004

0.02

0.04

NR, Not reached

* Did not cross significance boundary

Safety results

Tecentriq

BSC

All Grade AEs

92.7%

70.7%

Grade 3-4 Events

21.8%

11.5%

Grade 5 treatment-related AEs

0.8%

n/a

AEs leading to treatment withdrawal

18.2%

n/a

About lung cancer

According to the American Cancer Society, it is estimated that more than 235,000 Americans will be diagnosed with lung cancer in 2021, and NSCLC accounts for 80-85% of all lung cancers. Today, about half of all people with early lung cancer still experience a cancer recurrence following surgery, but treating lung cancer early, before it has spread, may help prevent the disease from returning and provide people with the best opportunity for a cure.

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 lung cancer called non-small cell lung cancer (NSCLC).

Tecentriq may be used alone as their first treatment when their lung 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 their first treatment when their lung cancer:
has spread or grown, and
is a type 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 their first treatment when their lung cancer:
has spread or grown, and
is a type called "non-squamous NSCLC," and
their tumor does not have an abnormal "EGFR" or "ALK" gene
Tecentriq may also be used when their lung cancer:
has spread or grown, and
they have tried chemotherapy that contains platinum, and it did not work or is no longer working
if their 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 lung cancer called small cell lung cancer (SCLC).

Tecentriq may be used with the chemotherapy medicines carboplatin and etoposide as their first treatment when their lung cancer:
is a type called "extensive-stage small cell lung cancer," which means that it has spread or grown
It is not known if Tecentriq is safe and effective in children.

Important Safety Information

What is the most important information about Tecentriq?

Tecentriq can cause the immune system to attack normal organs and tissues in any area of the body and can affect the way they work. These problems can sometimes become severe 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 their treatment or even after their treatment has ended.

Patients should call or see their healthcare provider right away if they develop any new or worse signs or symptoms, including:

Lung problems

cough
shortness of breath
chest pain
Intestinal problems

diarrhea (loose stools) or more frequent bowel movements than usual
stools that are black, tarry, sticky, or have blood or mucus
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 their stomach area (abdomen)
dark urine (tea colored)
bleeding or bruising more easily than normal
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
their voice gets deeper
dizziness or fainting
changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness
Kidney problems

decrease in their amount of urine
blood in their urine
swelling of their 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 patients undergo transplantation either before or after being treated with Tecentriq. A healthcare provider will monitor 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 also need to 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 received 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 their nervous system, such as myasthenia gravis or Guillain-Barré 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:
A healthcare provider should do a pregnancy test before they start treatment with Tecentriq
They 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 the breast milk. Patients should not breastfeed during treatment and for at least 5 months after the last dose of Tecentriq
Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

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
Tecentriq may cause fertility problems in females, which may affect the 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 about the benefits and side effects of Tecentriq.

Report side effects to the FDA at 1-800-FDA-1088 or View Source Report side effects to Genentech at 1-888-835-2555.

Please see View Source for full Prescribing Information and additional Important Safety Information.

About Genentech in cancer immunotherapy

Genentech has been developing medicines to redefine treatment in oncology for more than 35 years, and today, realizing the full potential of cancer immunotherapy is a major area of focus. With more than 20 immunotherapy molecules in development, Genentech is investigating the potential benefits of immunotherapy alone, and in combination with various chemotherapies, targeted therapies and other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system.

In addition to Genentech’s approved PD-L1 checkpoint inhibitor, the company’s broad cancer immunotherapy pipeline includes other checkpoint inhibitors, individualized neoantigen therapies and T cell bispecific antibodies. For more information visit View Source

About Genentech in lung cancer

Lung cancer is a major area of focus and investment for Genentech, and we are committed to developing new approaches, medicines and tests that can help people with this deadly disease. Our goal is to provide an effective treatment option for every person diagnosed with lung cancer. We currently have five approved medicines to treat certain kinds of lung cancer and more than 10 medicines being developed to target the most common genetic drivers of lung cancer or to boost the immune system to combat the disease.