Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that new oncology data will be presented at the European Society for Medical Oncology (ESMO) Congress, which will be held September 16-21, 2021. 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 Press Program.

“Our data at ESMO 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, 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 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 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

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: