On October 8, 2016 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported data from the positive, pivotal Phase III OAK study of TECENTRIQ (atezolizumab) at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2016 Annual Meeting in Copenhagen, Denmark (Press release, Genentech, OCT 8, 2016, View Source [SID:SID1234515659]). 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.

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"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 View Source . Report side effects to Genentech at (888) 835-2555.

Please visit View Source for the TECENTRIQ full Prescribing Information for additional Important Safety Information.