– TECENTRIQ provides survival benefit over chemotherapy even in people with low or no observed levels of PD-L1 expression –
– Data included overall survival results for squamous and non-squamous disease types –
– Full results will be presented at European Society of Medical Oncology Presidential Symposium –
SOUTH SAN FRANCISCO, CA, USA I October 8, 2016 I Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced data from the positive, pivotal Phase III OAK study of TECENTRIQ ® (atezolizumab) at the European Society of Medical Oncology (ESMO) 2016 Annual Meeting in Copenhagen, Denmark. The study showed TECENTRIQ helped people live a median of 13.8 months, 4.2 months longer than those treated with docetaxel chemotherapy (median overall survival [OS]: 13.8 vs. 9.6 months; HR = 0.73, 95% CI: 0.62 – 0.87). The OAK study evaluated people with non-small cell lung cancer (NSCLC) whose disease had progressed on or after treatment with one or more platinum-based chemotherapy (second-line and third-line). The study enrolled people regardless of their programmed death-ligand 1 (PD-L1) status and included both squamous and non-squamous disease types. Adverse events (AEs) were consistent with those observed in previous TECENTRIQ studies.
“TECENTRIQ is the first and only anti-PD-L1 cancer immunotherapy to help people with metastatic NSCLC live significantly longer than chemotherapy regardless of their PD-L1 expression level or their disease histology,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “Even people whose disease had low or no observed PD-L1 expression still showed a significant benefit from the medicine.”
The FDA granted Breakthrough Therapy Designation (BTD) for TECENTRIQ for the treatment of people with PD-L1-positive NSCLC whose disease has progressed during or after platinum-based chemotherapy (and appropriate targeted therapy for those with an EGFR mutation-positive or ALK-positive tumor). Genentech’s Biologics License Application (BLA) for NSCLC was granted Priority Review with an action date of Oct. 19, 2016.
Genentech has eight Phase III lung studies underway evaluating TECENTRIQ alone or in combination with other treatments in people with early and advanced stages of lung cancer.
Full results from the OAK study will be presented in the Presidential Symposium in a presentation by Fabrice Barlesi, Assistance Publique Hôpitaux de Marseille, Marseille, France (abstract #LBA44) on Sunday, Oct. 9, 4:25 p.m. Central European Time (CET). Primary analysis from OAK, a randomized Phase III study comparing atezolizumab with docetaxel in advanced NSCLC
About the OAK study
OAK is a global, multicenter, open-label, randomized, controlled Phase III study that evaluated the efficacy and safety of TECENTRIQ compared with docetaxel in 1,225 people with locally advanced or metastatic NSCLC whose disease had progressed following previous treatment with platinum-containing chemotherapy, with the primary analysis consisting of the first 850 randomized patients. Approximately one-quarter of patients had squamous disease (26 percent). Patients were randomized (1:1) to receive either TECENTRIQ administered intravenously at 1200 mg every 3 weeks or docetaxel administered intravenously at 75 mg/m2 every 3 weeks until unacceptable toxicity or disease progression. The co-primary endpoints were OS in all randomized patients (intention-to-treat [ITT] population) and in a PD-L1-selected subgroup in the primary analysis population. A summary of the OAK results is included below.
| Overall survival results |
| Study group |
ITT
(first 850 randomized patients)
|
TC1/2/3 or IC1/2/3
( PD-L1 expression on >1% TC or IC)
|
TC0 or IC0
( PD-L1 expression on <1% TC and IC)
|
|
Treatment arm
T = TECENTRIQ
D = Docetaxel
|
T |
D |
T |
D |
T |
D |
| N= |
425 |
425 |
241 |
222 |
180 |
199 |
| Median OS (months) |
13.8 |
9.6 |
15.7 |
10.3 |
12.6 |
8.9 |
|
HR*
(95% CI)
P** value
|
HR 0.73,
95% CI: 0.62 – 0.87
P = .0003
|
HR 0.74,
95% CI: 0.58 – 0.93
P = .0102
|
HR 0.75,
95% CI: 0.59 – 0.96
P = . 0205
|
| Overall survival by histology |
| Histology |
Non-squamous |
Squamous |
|
Treatment arm
T = TECENTRIQ
D = Docetaxel
|
T |
D |
T |
D |
| N= |
313 |
315 |
112 |
110 |
Median OS
(months) |
15.6 |
11.2 |
8.9 |
7.7 |
|
Unstratified HR
(95% CI)
|
HR 0.73,
95% CI: 0.60 – 0.89
|
HR 0.73,
95% CI: 0.54 – 0.98
|
| Safety-evaluable population (N=1187) |
|
· Adverse events were consistent with those observed in previous studies of TECENTRIQ.
· Fewer people receiving TECENTRIQ experienced treatment-related Grade 3-4 AEs compared to docetaxel (15% vs. 43%).
· AEs occurring more frequently (5% or more) for TECENTRIQ were musculoskeletal pain (11% for TECENTRIQ vs. 4% for docetaxel) and pruritus (8% for TECENTRIQ vs. 3% for docetaxel).
· There were no deaths related to TECENTRIQ and 1 related to docetaxel.
|
| The demographics and baseline characteristics were balanced between two arms. Patients had a median age of 64 years and 61% were male. 25% had 2 prior lines of therapies, and 18% never smoked. Baseline ECOG performance status was 0 (37%) or 1 (63%). About 17% of people in the docetaxel arm received immunotherapy as the subsequent therapy. |
|
*Unstratified for the TC0 and IC0 subgroup, stratified for others.
**Stratified log-rank p value.
CI: confidence interval; ITT: intention-to-treat; HR: hazard ratio; TC: tumor cells; IC: tumor-infiltrating immune cells; PD-L1: programmed death-ligand 1; OS: overall survival
|
| |
|
|
|
|
|
|
|
|
|
|
About Lung Cancer
According to the American Cancer Society, it is estimated that more than 224, 000 Americans will be diagnosed with lung cancer in 2016, and NSCLC accounts for up to 85 percent of all lung cancers. It is estimated that approximately 60 percent of lung cancer diagnoses in the United States are made when the disease is in the most advanced stages.
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 activation of T cells. TECENTRIQ may also affect normal cells.
TECENTRIQ is the first and only anti-PDL1 cancer immunotherapy approved by the FDA, and is indicated for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). This indication for TECENTRIQ 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 confirmatory trials.
TECENTRIQ U.S. Indication (pronounced ‘tē-SEN-trik’)
TECENTRIQ® is a prescription medicine used to treat:
- A type of bladder cancer called urothelial carcinoma. TECENTRIQ may be used when bladder cancer has spread or cannot be removed by surgery (advanced urothelial carcinoma) and,
- The patient has tried chemotherapy that contains platinum, and it did not work or is no longer working.
It is not known if TECENTRIQ is safe and effective in children.
Important Safety Information
Important Information About TECENTRIQ
TECENTRIQ can cause the immune system to attack normal organs and tissues in many areas of the body and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death.
Getting medical treatment right away may help keep these problems from becoming more serious. The healthcare provider may treat the patient with corticosteroid or hormone replacement medicines. The healthcare provider may delay or completely stop treatment with TECENTRIQ if severe side effects occur.
Patients should call or see their healthcare provider right away if they get any symptoms of the following problems or these symptoms get worse.
TECENTRIQ can cause serious side effects, including:
- Lung Problems (pneumonitis) – Signs and symptoms of pneumonitis may include: new or worsening cough, shortness of breath, or chest pain
- Liver Problems (hepatitis) – Signs and symptoms of hepatitis may include: 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, feeling less hungry than usual
- Intestinal Problems (colitis) – Signs and symptoms of colitis may include: diarrhea (loose stools) or more bowel movements than usual, blood in the stools or dark, tarry, sticky stools, severe stomach area (abdomen) pain or tenderness
- Hormone Gland Problems (especially the pituitary, thyroid, adrenal glands and pancreas) – Signs and symptoms that the hormone glands are not working properly may include: headaches that will not go away or unusual headaches, extreme tiredness, weight gain or weight loss, dizziness or fainting, feeling more hungry or thirsty than usual, hair loss, changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness, feeling cold, constipation, voice gets deeper, urinating more often than usual, nausea or vomiting, stomach area (abdomen) pain
- Nervous System Problems (neuropathy, meningoencephalitis) – Signs of nervous system problems may include: severe muscle weakness, numbness or tingling in hands and feet, fever, confusion, changes in mood or behavior, extreme sensitivity to light, neck stiffness
- Inflammation of the Eyes – Symptoms may include blurry vision, double vision, other vision problems, eye pain or redness
- Severe Infections – Symptoms of infection may include: fever, cough, frequent urination, flu-like symptoms, pain when urinating
- Severe Infusion Reactions – Signs and symptoms of infusion reactions may include: chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, fever, feeling like passing out, back or neck pain, facial swelling
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 lung or breathing problems; have liver problems; have a condition that affects the nervous system, such as myasthenia gravis or Guillain-Barre syndrome; or are being treated for an infection.
- are pregnant or plan to become pregnant.
o TECENTRIQ can harm an unborn baby.
o If patients are able to become pregnant, they should use an effective method of birth control during treatment and for at least 5 months after the last dose of TECENTRIQ.
- are breastfeeding or plan to breastfeed.
o It is not known if TECENTRIQ passes into the breast milk.
o Do not breastfeed during treatment and for at least 5 months after the last dose of TECENTRIQ.
The most common side effects of TECENTRIQ include:
- feeling tired
- decreased appetite
- nausea
- urinary tract infection
- fever
- constipation
These are not all the possible side effects of TECENTRIQ. Patients should ask their healthcare provider or pharmacist for more information.
Patients should tell their healthcare provider about all of the medicines they take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
Report side effects to the FDA at (800) FDA-1088, or http://www.fda.gov/medwatch . Report side effects to Genentech at (888) 835-2555.
Please visit http://www.TECENTRIQ.com for the TECENTRIQ full Prescribing Information for additional Important Safety Information.
About Genentech in Personalized Cancer Immunotherapy
For more than 30 years, Genentech has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever to bring personalized cancer immunotherapy (PCI) to people with cancer. The goal of PCI is to provide each person with a treatment tailored to harness his or her own immune system to fight cancer. Genentech is studying more than 20 investigational medicines, 10 of which are in clinical trials. In every study we are evaluating biomarkers to identify which people may be appropriate candidates for our medicines. For more information visit http://www.gene.com/cancer-immunotherapy.
About Genentech
Founded 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.
SOURCE: Genentech
Post Views: 41
– TECENTRIQ provides survival benefit over chemotherapy even in people with low or no observed levels of PD-L1 expression –
– Data included overall survival results for squamous and non-squamous disease types –
– Full results will be presented at European Society of Medical Oncology Presidential Symposium –
SOUTH SAN FRANCISCO, CA, USA I October 8, 2016 I Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced data from the positive, pivotal Phase III OAK study of TECENTRIQ ® (atezolizumab) at the European Society of Medical Oncology (ESMO) 2016 Annual Meeting in Copenhagen, Denmark. The study showed TECENTRIQ helped people live a median of 13.8 months, 4.2 months longer than those treated with docetaxel chemotherapy (median overall survival [OS]: 13.8 vs. 9.6 months; HR = 0.73, 95% CI: 0.62 – 0.87). The OAK study evaluated people with non-small cell lung cancer (NSCLC) whose disease had progressed on or after treatment with one or more platinum-based chemotherapy (second-line and third-line). The study enrolled people regardless of their programmed death-ligand 1 (PD-L1) status and included both squamous and non-squamous disease types. Adverse events (AEs) were consistent with those observed in previous TECENTRIQ studies.
“TECENTRIQ is the first and only anti-PD-L1 cancer immunotherapy to help people with metastatic NSCLC live significantly longer than chemotherapy regardless of their PD-L1 expression level or their disease histology,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “Even people whose disease had low or no observed PD-L1 expression still showed a significant benefit from the medicine.”
The FDA granted Breakthrough Therapy Designation (BTD) for TECENTRIQ for the treatment of people with PD-L1-positive NSCLC whose disease has progressed during or after platinum-based chemotherapy (and appropriate targeted therapy for those with an EGFR mutation-positive or ALK-positive tumor). Genentech’s Biologics License Application (BLA) for NSCLC was granted Priority Review with an action date of Oct. 19, 2016.
Genentech has eight Phase III lung studies underway evaluating TECENTRIQ alone or in combination with other treatments in people with early and advanced stages of lung cancer.
Full results from the OAK study will be presented in the Presidential Symposium in a presentation by Fabrice Barlesi, Assistance Publique Hôpitaux de Marseille, Marseille, France (abstract #LBA44) on Sunday, Oct. 9, 4:25 p.m. Central European Time (CET). Primary analysis from OAK, a randomized Phase III study comparing atezolizumab with docetaxel in advanced NSCLC
About the OAK study
OAK is a global, multicenter, open-label, randomized, controlled Phase III study that evaluated the efficacy and safety of TECENTRIQ compared with docetaxel in 1,225 people with locally advanced or metastatic NSCLC whose disease had progressed following previous treatment with platinum-containing chemotherapy, with the primary analysis consisting of the first 850 randomized patients. Approximately one-quarter of patients had squamous disease (26 percent). Patients were randomized (1:1) to receive either TECENTRIQ administered intravenously at 1200 mg every 3 weeks or docetaxel administered intravenously at 75 mg/m2 every 3 weeks until unacceptable toxicity or disease progression. The co-primary endpoints were OS in all randomized patients (intention-to-treat [ITT] population) and in a PD-L1-selected subgroup in the primary analysis population. A summary of the OAK results is included below.
| Overall survival results |
| Study group |
ITT
(first 850 randomized patients)
|
TC1/2/3 or IC1/2/3
( PD-L1 expression on >1% TC or IC)
|
TC0 or IC0
( PD-L1 expression on <1% TC and IC)
|
|
Treatment arm
T = TECENTRIQ
D = Docetaxel
|
T |
D |
T |
D |
T |
D |
| N= |
425 |
425 |
241 |
222 |
180 |
199 |
| Median OS (months) |
13.8 |
9.6 |
15.7 |
10.3 |
12.6 |
8.9 |
|
HR*
(95% CI)
P** value
|
HR 0.73,
95% CI: 0.62 – 0.87
P = .0003
|
HR 0.74,
95% CI: 0.58 – 0.93
P = .0102
|
HR 0.75,
95% CI: 0.59 – 0.96
P = . 0205
|
| Overall survival by histology |
| Histology |
Non-squamous |
Squamous |
|
Treatment arm
T = TECENTRIQ
D = Docetaxel
|
T |
D |
T |
D |
| N= |
313 |
315 |
112 |
110 |
Median OS
(months) |
15.6 |
11.2 |
8.9 |
7.7 |
|
Unstratified HR
(95% CI)
|
HR 0.73,
95% CI: 0.60 – 0.89
|
HR 0.73,
95% CI: 0.54 – 0.98
|
| Safety-evaluable population (N=1187) |
|
· Adverse events were consistent with those observed in previous studies of TECENTRIQ.
· Fewer people receiving TECENTRIQ experienced treatment-related Grade 3-4 AEs compared to docetaxel (15% vs. 43%).
· AEs occurring more frequently (5% or more) for TECENTRIQ were musculoskeletal pain (11% for TECENTRIQ vs. 4% for docetaxel) and pruritus (8% for TECENTRIQ vs. 3% for docetaxel).
· There were no deaths related to TECENTRIQ and 1 related to docetaxel.
|
| The demographics and baseline characteristics were balanced between two arms. Patients had a median age of 64 years and 61% were male. 25% had 2 prior lines of therapies, and 18% never smoked. Baseline ECOG performance status was 0 (37%) or 1 (63%). About 17% of people in the docetaxel arm received immunotherapy as the subsequent therapy. |
|
*Unstratified for the TC0 and IC0 subgroup, stratified for others.
**Stratified log-rank p value.
CI: confidence interval; ITT: intention-to-treat; HR: hazard ratio; TC: tumor cells; IC: tumor-infiltrating immune cells; PD-L1: programmed death-ligand 1; OS: overall survival
|
| |
|
|
|
|
|
|
|
|
|
|
About Lung Cancer
According to the American Cancer Society, it is estimated that more than 224, 000 Americans will be diagnosed with lung cancer in 2016, and NSCLC accounts for up to 85 percent of all lung cancers. It is estimated that approximately 60 percent of lung cancer diagnoses in the United States are made when the disease is in the most advanced stages.
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 activation of T cells. TECENTRIQ may also affect normal cells.
TECENTRIQ is the first and only anti-PDL1 cancer immunotherapy approved by the FDA, and is indicated for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-based chemotherapy, or whose disease has worsened within 12 months of receiving platinum-based chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant). This indication for TECENTRIQ 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 confirmatory trials.
TECENTRIQ U.S. Indication (pronounced ‘tē-SEN-trik’)
TECENTRIQ® is a prescription medicine used to treat:
- A type of bladder cancer called urothelial carcinoma. TECENTRIQ may be used when bladder cancer has spread or cannot be removed by surgery (advanced urothelial carcinoma) and,
- The patient has tried chemotherapy that contains platinum, and it did not work or is no longer working.
It is not known if TECENTRIQ is safe and effective in children.
Important Safety Information
Important Information About TECENTRIQ
TECENTRIQ can cause the immune system to attack normal organs and tissues in many areas of the body and can affect the way they work. These problems can sometimes become serious or life-threatening and can lead to death.
Getting medical treatment right away may help keep these problems from becoming more serious. The healthcare provider may treat the patient with corticosteroid or hormone replacement medicines. The healthcare provider may delay or completely stop treatment with TECENTRIQ if severe side effects occur.
Patients should call or see their healthcare provider right away if they get any symptoms of the following problems or these symptoms get worse.
TECENTRIQ can cause serious side effects, including:
- Lung Problems (pneumonitis) – Signs and symptoms of pneumonitis may include: new or worsening cough, shortness of breath, or chest pain
- Liver Problems (hepatitis) – Signs and symptoms of hepatitis may include: 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, feeling less hungry than usual
- Intestinal Problems (colitis) – Signs and symptoms of colitis may include: diarrhea (loose stools) or more bowel movements than usual, blood in the stools or dark, tarry, sticky stools, severe stomach area (abdomen) pain or tenderness
- Hormone Gland Problems (especially the pituitary, thyroid, adrenal glands and pancreas) – Signs and symptoms that the hormone glands are not working properly may include: headaches that will not go away or unusual headaches, extreme tiredness, weight gain or weight loss, dizziness or fainting, feeling more hungry or thirsty than usual, hair loss, changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness, feeling cold, constipation, voice gets deeper, urinating more often than usual, nausea or vomiting, stomach area (abdomen) pain
- Nervous System Problems (neuropathy, meningoencephalitis) – Signs of nervous system problems may include: severe muscle weakness, numbness or tingling in hands and feet, fever, confusion, changes in mood or behavior, extreme sensitivity to light, neck stiffness
- Inflammation of the Eyes – Symptoms may include blurry vision, double vision, other vision problems, eye pain or redness
- Severe Infections – Symptoms of infection may include: fever, cough, frequent urination, flu-like symptoms, pain when urinating
- Severe Infusion Reactions – Signs and symptoms of infusion reactions may include: chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, fever, feeling like passing out, back or neck pain, facial swelling
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 lung or breathing problems; have liver problems; have a condition that affects the nervous system, such as myasthenia gravis or Guillain-Barre syndrome; or are being treated for an infection.
- are pregnant or plan to become pregnant.
o TECENTRIQ can harm an unborn baby.
o If patients are able to become pregnant, they should use an effective method of birth control during treatment and for at least 5 months after the last dose of TECENTRIQ.
- are breastfeeding or plan to breastfeed.
o It is not known if TECENTRIQ passes into the breast milk.
o Do not breastfeed during treatment and for at least 5 months after the last dose of TECENTRIQ.
The most common side effects of TECENTRIQ include:
- feeling tired
- decreased appetite
- nausea
- urinary tract infection
- fever
- constipation
These are not all the possible side effects of TECENTRIQ. Patients should ask their healthcare provider or pharmacist for more information.
Patients should tell their healthcare provider about all of the medicines they take, including prescription and over-the-counter medicines, vitamins and herbal supplements.
Report side effects to the FDA at (800) FDA-1088, or http://www.fda.gov/medwatch . Report side effects to Genentech at (888) 835-2555.
Please visit http://www.TECENTRIQ.com for the TECENTRIQ full Prescribing Information for additional Important Safety Information.
About Genentech in Personalized Cancer Immunotherapy
For more than 30 years, Genentech has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever to bring personalized cancer immunotherapy (PCI) to people with cancer. The goal of PCI is to provide each person with a treatment tailored to harness his or her own immune system to fight cancer. Genentech is studying more than 20 investigational medicines, 10 of which are in clinical trials. In every study we are evaluating biomarkers to identify which people may be appropriate candidates for our medicines. For more information visit http://www.gene.com/cancer-immunotherapy.
About Genentech
Founded 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.
SOURCE: Genentech
Post Views: 41
