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.