Pivotal Phase III Data at ASCO Show Genentech?s Tecentriq Helps Certain People With Early Lung Cancer Live Significantly Longer Without Their Disease Returning
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced 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). In this population, median DFS was not yet reached for Tecentriq compared with 35.3 months for BSC.
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 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
Safety results
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).
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 |
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 |
- 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
- 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
- cough
- shortness of breath
- chest pain
- 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
- 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
- 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
- decrease in their amount of urine
- blood in their urine
- swelling of their ankles
- loss of appetite
- 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
- 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
- chills or shaking
- itching or rash
- flushing
- shortness of breath or wheezing
- dizziness
- feeling like passing out
- fever
- back or neck pain
- 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-Barr? 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
- feeling tired or weak
- nausea
- cough
- shortness of breath
- decreased appetite
- feeling tired or weak
- nausea
- hair loss
- constipation
- diarrhea
- decreased appetite