TECENTRIQ: First- and Second-Line Approvals Based on Pivotal Studies

1L combination for nsqNSCLC

IMpower150 study

A Phase III, multicenter, international, randomized, open-label, 3-arm trial in chemotherapy-naive patients with metastatic nsqNSCLC1,2

TECENTRIQ® (atezolizumab) NSCLC 1L IMpower150 Trial

Patients received IV infusions of TECENTRIQ 1200 mg, Avastin 15 mg/kg, carboplatin AUC 6 mg/mL/min, and paclitaxel 175 mg/m2 or 200 mg/mq3w. After the induction phase, patients continued to receive TECENTRIQ, Avastin, or both every 3 weeks until disease progression or unacceptable toxicity. This study excluded patients who had a history of autoimmune disease; administration of a live, attenuated vaccine within 28 days prior to randomization; active or untreated CNS metastases; administration of systemic immunostimulatory agents within 4 weeks or systemic immunosuppressive medications within 2 weeks prior to randomization; clear tumor infiltration into the thoracic great vessels or clear cavitation of pulmonary lesions as seen on imaging.

Efficacy data were stratified by the presence of liver metastases, PD-L1 expression status,* and gender

Coprimary endpoints1
  • Overall survival in the ITT-WT subpopulation
  • Progression-free survival using RECIST v1.1 in the ITT-WT subpopulation
Key secondary endpoints1
  • Overall response rate and duration of response in the ITT-WT subpopulation

1L=first line; 2L=second line; AUC=area under the concentration-time curve; carbo/pac=carboplatin and paclitaxel; CNS=central nervous system; IC=tumor-infiltrating immune cells; ITT=intent to treat; IV=intravenous; nsqNSCLC=non-squamous non-small cell lung cancer; PD-L1=programmed death-ligand 1; q3w=every 3 weeks; q6w=every 6 weeks; q9w=every 9 weeks; RECIST=Response Evaluation Criteria In Solid Tumors; TC=tumor cells; WT=wild-type.
*TC ≥50% and IC ≥1% vs TC <50% and IC ≥5% vs TC <50% and IC <5%.6
As determined by independent review facility per RECIST v1.1.

TECENTRIQ + Avastin® (bevacizumab) + carbo/pac was evaluated across key patient types1-3

TECENTRIQ® (atezolizumab) NSCLC 1L IMpower150 Baseline Characteristics

ALK=anaplastic lymphoma kinase; ECOG=Eastern Cooperative Oncology Group; EGFR=epidermal growth factor receptor; NSCLC=non-small cell lung cancer; PS=performance status.

  • The demographics for the 696 patients in the ITT-WT subpopulation were similar to the ITT population, except for the absence of patients with EGFR- or ALK-positive NSCLC
1L monotherapy

IMpower110 study

A Phase III, multicenter, international, randomized, open-label trial in chemotherapy-naive PD-L1+ patients with squamous or non-squamous mNSCLC (N=572; ITT-WT: n=554*)1,3,4

TECENTRIQ® (atezolizumab) NSCLC 1L IMpower110 Study Design

In the study, patients received either TECENTRIQ 1200 mg intravenously on Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity, or platinum-based chemotherapy consisting of carboplatin or cisplatin on Day 1 with either pemetrexed on Day 1 (non-squamous disease) or gemcitabine on Days 1 and 8 (squamous disease) of each 21-day cycle for 4 or 6 cycles, followed by pemetrexed (non-squamous disease) or best supportive care (squamous disease) until disease progression or unacceptable toxicity. Randomization was stratified by ECOG PS, histology (non-squamous vs squamous), PD-L1 expression on TC and IC, and gender; analyses were stratified by ECOG PS and gender only. The trial excluded patients with a history of autoimmune disease; administration of live, attenuated vaccine within 28 days prior to randomization; active or untreated CNS metastases; and/or administration of systemic immunostimulatory agents within 4 weeks or systemic immunosuppressive medications within 2 weeks prior to randomization.

Primary endpoint was OS in PD-L1–selected subgroups in the ITT-WT population, which was tested hierarchically
TECENTRIQ® (atezolizumab) NSCLC 1L IMpower110 PD-L1 Subgroup Hierarchy
Select secondary endpoints
  • Progression-free survival (PFS)
  • Objective response rate (ORR)
  • Duration of response (DoR)

1L=first line; 2L=second line; ALK=anaplastic lymphoma kinase; CNS=central nervous system; ECOG=Eastern Cooperative Oncology Group; EGFR=epidermal growth factor receptor; IC=tumor-infiltrating immune cells; ITT=intent to treat; mNSCLC=metastatic non-small cell lung cancer; nsq=non-squamous; OS=overall survival; PD-L1=programmed death-ligand 1; PS=performance status; RECIST=Response Evaluation Criteria In Solid Tumors; sq=squamous; TC=tumor cells; q3w=every 3 weeks; WT=wild-type.

*ITT-WT refers to patients who did not have EGFR or ALK genomic tumor aberrations.
Investigator-assessed per RECIST v1.1.

IMpower110 assessed TECENTRIQ monotherapy in a broad patient population, with baseline characteristics generally well balanced between treatment arms1,3,4

PD-L1–high (TC ≥50% or IC ≥10%) population baseline characteristics
TECENTRIQ® (atezolizumab) NSCLC 1L IMpower110 Baseline Characteristics

TECENTRIQ monotherapy is approved in patients with 1L PD-L1–high mNSCLC, as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations

2L monotherapy

OAK study

The largest pivotal Phase III cancer immunotherapy study that enrolled previously treated metastatic NSCLC patients regardless of PD-L1 expression1,5

Multicenter, international, randomized, open-label trial evaluating TECENTRIQ against docetaxel
TECENTRIQ® (atezolizumab) NSCLC OAK Study Design Phase 3
Primary endpoint
  • Overall survival*
Secondary endpoints
  • Duration of response
  • Overall response rate per RECIST v1.1
  • Progression-free survival per RECIST v1.1

Randomization was stratified by PD-L1 expression in IC, the number of prior chemotherapy regimens, and histology. Tumor specimens were evaluated prospectively using the VENTANA PD-L1 (SP142) Assay. Patients with a history of autoimmune disease, symptomatic or corticosteroid-dependent brain metastases, or requiring systemic immunosuppression within 2 weeks prior to enrollment were ineligible.
*The major efficacy outcome measure was OS in the first 850 randomized patients and in the TC or IC ≥1% PD-L1–expression subgroup. Additional efficacy outcome measures included OS in all 1225 randomized patients and in additional PD-L1–expression subgroups.

Select demographics from the OAK study1

TECENTRIQ® (atezolizumab) NSCLC 2L OAK PD L1 Study Results

In the OAK study, nearly half of patients did not have PD-L1–expressing tumors

1L=first line; 2L=second line; IC=tumor-infiltrating immune cells; IV=intravenous; NSCLC=non-small cell lung cancer; OS=overall survival; PD-L1=programmed death-ligand 1; q3w=every 3 weeks; q6w=every 6 weeks; q9w=every 9 weeks; RECIST=Response Evaluation Criteria In Solid Tumors; TC=tumor cells.
Non–PD-L1–expressing=TC and IC <1%; PD-L1–expressing=TC or IC ≥1%.5

Baseline characteristics were generally well balanced between treatment arms5

TECENTRIQ® (atezolizumab) NSCLC 2L OAK Baseline Characteristics

ALK=anaplastic lymphoma kinase; ECOG=Eastern Cooperative Oncology Group; EGFR=epidermal growth factor receptor; PS=performance status.
Tumor tissue for 8 patients was not evaluable for TC or IC ≥1%.

Indications

TECENTRIQ, as a single agent, is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1–stained ≥50% of tumor cells [TC ≥50%] or PD-L1–stained tumor-infiltrating immune cells [IC] covering ≥10% of the tumor area [IC ≥10%]), as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

TECENTRIQ, in combination with bevacizumab, paclitaxel, and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous, non-small cell lung cancer (nsqNSCLC) with no EGFR or ALK genomic tumor aberrations.

TECENTRIQ, in combination with paclitaxel protein-bound and carboplatin, is indicated for the first-line treatment of adult patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations.

TECENTRIQ, as a single agent, is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for NSCLC harboring these aberrations prior to receiving TECENTRIQ.

ALK=anaplastic lymphoma kinase; EGFR=epidermal growth factor receptor; PD-L1=programmed death-ligand 1.

Serious Adverse Reactions
Please refer to the full Prescribing Information for important dose management information specific to adverse reactions.

Severe and Fatal Immune-Mediated Adverse Reactions
TECENTRIQ is a monoclonal antibody that belongs to a class of drugs that bind to either the programmed death-receptor 1 (PD-1) or the PD-ligand 1 (PD-L1), blocking the PD-1/PD-L1 pathway, thereby removing inhibition of the immune response, potentially breaking peripheral tolerance and inducing immune-mediated adverse reactions. The following immune-mediated adverse reactions may not include all possible severe and fatal immune-mediated reactions.

Immune-mediated adverse reactions can occur in any organ system or tissue and at any time after starting a PD-1/PD-L1 blocking antibody. While immune-mediated adverse reactions usually manifest during treatment with PD-1/PD-L1 blocking antibodies, they can also manifest after discontinuation of treatment.

Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate liver enzymes, creatinine, and thyroid function at baseline and periodically during treatment. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue TECENTRIQ depending on severity. In general, if TECENTRIQ requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less, then initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy.

Immune-Mediated Pneumonitis

  • TECENTRIQ can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation
  • Immune-mediated pneumonitis occurred in 3% (83/2616) of patients receiving TECENTRIQ as a single agent, including fatal (<0.1%), Grade 4 (0.2%), Grade 3 (0.8%), and Grade 2 (1.1%) adverse reactions. Pneumonitis led to permanent discontinuation of TECENTRIQ in 0.5% and withholding of TECENTRIQ in 1.5% of patients. Systemic corticosteroids were required in 55% (46/83) of patients with pneumonitis

Immune-Mediated Colitis

  • TECENTRIQ can cause immune-mediated colitis. Colitis can present with diarrhea, abdominal pain, and lower gastrointestinal (GI) bleeding. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies
  • Immune-mediated colitis occurred in 1% (26/2616) of patients receiving TECENTRIQ as a single agent, including Grade 3 (0.5%) and Grade 2 (0.3%) adverse reactions. Colitis led to permanent discontinuation of TECENTRIQ in 0.2% and withholding of TECENTRIQ in 0.5% of patients. Systemic corticosteroids were required in 50% (13/26) of patients with colitis. Colitis resolved in 73% of the 26 patients. Of the 12 patients in whom TECENTRIQ was withheld for colitis, 8 reinitiated treatment with TECENTRIQ after symptom improvement; of these, 25% had recurrence of colitis

Immune-Mediated Hepatitis

  • TECENTRIQ can cause immune-mediated hepatitis. Immune-mediated hepatitis occurred in 1.8% (48/2616) of patients receiving TECENTRIQ as a single agent, including fatal (<0.1%), Grade 4 (0.2%), Grade 3 (0.5%), and Grade 2 (0.5%) adverse reactions. Hepatitis led to permanent discontinuation of TECENTRIQ in 0.2% and withholding of TECENTRIQ in 0.2% of patients. Systemic corticosteroids were required in 25% (12/48) of patients with hepatitis. Hepatitis resolved in 50% of the 48 patients. Of the 6 patients in whom TECENTRIQ was withheld for hepatitis, 4 reinitiated treatment with TECENTRIQ after symptom improvement; of these, none had recurrence of hepatitis

Immune-Mediated Endocrinopathies
Adrenal Insufficiency

  • TECENTRIQ can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated
  • Adrenal insufficiency occurred in 0.4% (11/2616) of patients receiving TECENTRIQ as a single agent, including Grade 3 (<0.1%) and Grade 2 (0.2%) adverse reactions. Adrenal insufficiency led to permanent discontinuation of TECENTRIQ in 1 patient and withholding of TECENTRIQ in 1 patient. Systemic corticosteroids were required in 81% (9/11) of patients with adrenal insufficiency; of these, 3 patients remained on systemic corticosteroids. The single patient in whom TECENTRIQ was withheld for adrenal insufficiency did not reinitiate TECENTRIQ

Hypophysitis

  • TECENTRIQ can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. Hypophysitis can cause hypopituitarism. Initiate hormone replacement as clinically indicated
  • Hypophysitis occurred in <0.1% (2/2616) of patients receiving TECENTRIQ as a single agent, including Grade 2 (1 patient, <0.1%) adverse reactions. Hypophysitis led to permanent discontinuation of TECENTRIQ in 1 patient and no patients required withholding of TECENTRIQ. Systemic corticosteroids were required in 50% (1/2) of patients with hypophysitis. Hypophysitis did not resolve in these 2 patients

Thyroid Disorders

  • TECENTRIQ can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement for hypothyroidism or medical management for hyperthyroidism as clinically indicated
  • Thyroiditis occurred in 0.2% (4/2616) of patients receiving TECENTRIQ as a single agent, including Grade 2 (<0.1%) adverse reactions. Thyroiditis did not lead to permanent discontinuation of TECENTRIQ in any of these patients, but led to withholding of TECENTRIQ in 1 patient. Hormone replacement therapy was required in 75% (3/4) of patients with thyroiditis. Systemic corticosteroids were required in 25% (1/4) of patients with thyroiditis. Thyroiditis resolved in 50% of patients. The single patient in whom TECENTRIQ was withheld for thyroiditis reinitiated TECENTRIQ; this patient did not have recurrence of thyroiditis
  • Hyperthyroidism occurred in 0.8% (21/2616) of patients receiving TECENTRIQ as a single agent, including Grade 2 (0.4%) adverse reactions. Hyperthyroidism did not lead to permanent discontinuation of TECENTRIQ in any of these patients, but led to withholding of TECENTRIQ in 0.1% of patients. Antithyroid therapy was required in 29% (6/21) of patients with hyperthyroidism. Of these 6 patients, the majority remained on antithyroid treatment. Of the 3 patients in whom TECENTRIQ was withheld for hyperthyroidism, 1 patient reinitiated TECENTRIQ; this patient did not have recurrence of hyperthyroidism
  • Hypothyroidism occurred in 4.9% (128/2616) of patients receiving TECENTRIQ as a single agent, including Grade 3 (0.2%) and Grade 2 (3.4%) adverse reactions. Hypothyroidism did not lead to permanent discontinuation of TECENTRIQ in any of these patients, but led to withholding of TECENTRIQ in 0.6% of patients. Hormone replacement therapy was required in 81% (104/128) of patients with hypothyroidism. The majority of patients with hypothyroidism remained on thyroid hormone replacement. Of the 17 patients in whom TECENTRIQ was withheld for hypothyroidism, 8 reinitiated TECENTRIQ after symptom improvement
  • Hypothyroidism occurred in 11% (277/2421) of patients with NSCLC and SCLC receiving TECENTRIQ in combination with platinum-based chemotherapy, including Grade 4 (<0.1%), Grade 3 (0.3%), and Grade 2 (5.7%) adverse reactions. Hypothyroidism led to permanent discontinuation of TECENTRIQ in 0.1% and withholding of TECENTRIQ in 1.6% of patients. Hormone replacement therapy was required in 71% (198/277) of patients with hypothyroidism. The majority of patients with hypothyroidism remained on thyroid hormone replacement. Of the 39 patients in whom TECENTRIQ was withheld for hypothyroidism, 9 reinitiated TECENTRIQ after symptom improvement

Type 1 Diabetes Mellitus, Which Can Present With Diabetic Ketoacidosis

  • Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated
  • Type 1 diabetes mellitus occurred in 0.3% (7/2616) of patients receiving TECENTRIQ as a single agent, including Grade 3 (0.2%) and Grade 2 (<0.1%) adverse reactions. Type 1 diabetes mellitus led to permanent discontinuation of TECENTRIQ in 1 patient and withholding of TECENTRIQ in 2 patients. Treatment with insulin was required for all patients with confirmed Type 1 diabetes mellitus and insulin therapy was continued long-term. Of the 2 patients in whom TECENTRIQ was withheld for Type 1 diabetes mellitus, both reinitiated TECENTRIQ treatment

Immune-Mediated Nephritis With Renal Dysfunction

  • TECENTRIQ can cause immune-mediated nephritis
  • Immune-mediated nephritis with renal dysfunction occurred in <0.1% (1/2616) of patients receiving TECENTRIQ as a single agent, and this adverse reaction was a Grade 3 (<0.1%) adverse reaction. Nephritis led to permanent discontinuation of TECENTRIQ in this patient. This patient required systemic corticosteroids. In this patient, nephritis did not resolve

Immune-Mediated Dermatologic Adverse Reactions

  • TECENTRIQ can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson syndrome (SJS), DRESS, and toxic epidermal necrolysis (TEN), has occurred with PD-1/PD-L1 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes 
  • Immune-mediated dermatologic adverse reactions occurred in 0.6% (15/2616) of patients receiving TECENTRIQ as a single agent, including Grade 3 (<0.1%) and Grade 2 (0.2%) adverse reactions. Dermatologic adverse reactions led to permanent discontinuation of TECENTRIQ in 0.1% and withholding of TECENTRIQ in 0.2% of patients. Systemic corticosteroids were required in 20% (3/15) of patients with dermatologic adverse reactions. Dermatologic adverse reactions resolved in 87% of the 15 patients. Of the 4 patients in whom TECENTRIQ was withheld for immune-mediated dermatologic adverse reactions, none reinitiated TECENTRIQ

Other Immune-Mediated Adverse Reactions

  • The following clinically significant immune-mediated adverse reactions occurred at an incidence of <1% (unless otherwise noted) in patients who received TECENTRIQ or were reported with the use of other PD-1/PD-L1 blocking antibodies
    • Cardiac/Vascular: Myocarditis, pericarditis, vasculitis
    • Nervous System: Meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis (including exacerbation), Guillain-Barré syndrome, nerve paresis, autoimmune neuropathy
    • Ocular: Uveitis, iritis, and other ocular inflammatory toxicities can occur. Some cases can be associated with retinal detachment. Various grades of visual impairment, including blindness, can occur. If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, as this may require treatment with systemic steroids to reduce the risk of permanent vision loss
    • Gastrointestinal: Pancreatitis to include increases in serum amylase and lipase levels, gastritis, duodenitis
    • Musculoskeletal and Connective Tissue: Myositis/polymyositis, rhabdomyolysis and associated sequelae including renal failure, arthritis, polymyalgia rheumatic
    • Endocrine: Hypoparathyroidism
    • Other (Hematologic/Immune): Hemolytic anemia, aplastic anemia, hemophagocytic lymphohistiocytosis, systemic inflammatory response syndrome, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), sarcoidosis, immune thrombocytopenic purpura, solid organ transplant rejection

Infusion-Related Reactions

  • TECENTRIQ can cause severe or life-threatening infusion-related reactions. Monitor for signs and symptoms of infusion-related reactions. Interrupt, slow the rate of, or permanently discontinue TECENTRIQ based on the severity. For Grade 1 or 2 infusion-related reactions, consider using pre-medications with subsequent doses
  • Infusion-related reactions occurred in 1.3% of patients receiving TECENTRIQ as a single agent, including Grade 3 (0.2%) reactions
  • The frequency and severity of infusion-related reactions were similar whether TECENTRIQ was given as a single agent, in combination with other antineoplastic drugs in NSCLC and SCLC, and across the recommended dose range

Complications of Allogeneic HSCT After PD-1/PD-L1 Inhibitors

  • Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1 blocking antibody
  • Transplant-related complications include hyperacute graft-versus-host disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause)
  • These complications may occur despite intervening therapy between PD-1/PD-L1 blockage and allogeneic HSCT
  • Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefits versus risks of treatment with a PD-1/PD-L1 blocking antibody prior to or after an allogeneic HSCT

Embryo-Fetal Toxicity

  • Based on its mechanism of action, TECENTRIQ can cause fetal harm when administered to a pregnant woman. There are no available data on the use of TECENTRIQ in pregnant women. Animal studies have demonstrated that inhibition of the PD-L1/PD-1 pathway can lead to increased risk of immune-related rejection of the developing fetus, resulting in fetal death
  • Verify pregnancy status of females of reproductive potential prior to initiating TECENTRIQ. Advise females of reproductive potential of the potential risk to a fetus and to use effective contraception during treatment with TECENTRIQ and for at least 5 months after the last dose

Use In Specific Populations
Nursing Mothers

  • There is no information regarding the presence of TECENTRIQ in human milk, the effects on the breastfed infant, or the effects on milk production. As human IgG is excreted in human milk, the potential for absorption and harm to the infant is unknown
  • Because of the potential for serious adverse reactions in breastfed infants from TECENTRIQ, advise female patients not to breastfeed while taking TECENTRIQ and for at least 5 months after the last dose

Fertility

  • Based on animal studies, TECENTRIQ may impair fertility in females of reproductive potential while receiving treatment

Most Common Adverse Reactions
The most common adverse reactions (rate ≥20%) in patients who received TECENTRIQ alone were fatigue/asthenia (48%), decreased appetite (25%), nausea (24%), cough (22%), and dyspnea (22%).

The most common adverse reactions (rate ≥20%) in patients who received TECENTRIQ in combination with other antineoplastic drugs for NSCLC and SCLC were fatigue/asthenia (49%), nausea (38%), alopecia (35%), constipation (29%), diarrhea (28%), and decreased appetite (27%).

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at 1-888-835-2555.

Please see full Prescribing Information for additional Important Safety Information.

    • TECENTRIQ Prescribing Information. Genentech, Inc.

      TECENTRIQ Prescribing Information. Genentech, Inc.

    • Socinski MA, Jotte RM, Cappuzzo F, et al; IMpower150 Study Group. Atezolizumab for first-line treatment of metastatic nonsquamous NSCLC. N Engl J Med. 2018;378:2288-2301.

      Socinski MA, Jotte RM, Cappuzzo F, et al; IMpower150 Study Group. Atezolizumab for first-line treatment of metastatic nonsquamous NSCLC. N Engl J Med. 2018;378:2288-2301.

    • Data on file. Genentech, Inc.

      Data on file. Genentech, Inc.

    • Spigel DR, De Marinis F, Giaccone G, et al. IMpower110: interim OS analysis of a phase III study of atezolizumab (atezo) vs platinum-based chemotherapy (chemo) as 1L treatment (tx) in PD-L1–selected NSCLC. Presented at: ESMO Congress; September 27, 2019; Barcelona, Spain.

      Spigel DR, De Marinis F, Giaccone G, et al. IMpower110: interim OS analysis of a phase III study of atezolizumab (atezo) vs platinum-based chemotherapy (chemo) as 1L treatment (tx) in PD-L1–selected NSCLC. Presented at: ESMO Congress; September 27, 2019; Barcelona, Spain.

    • Rittmeyer A, Barlesi F, Waterkamp D, et al; OAK Study Group. Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Lancet. 2017;389:255-265.

      Rittmeyer A, Barlesi F, Waterkamp D, et al; OAK Study Group. Atezolizumab versus docetaxel in patients with previously treated non-small-cell lung cancer (OAK): a phase 3, open-label, multicentre randomised controlled trial. Lancet. 2017;389:255-265.

    • Vennapusa B, Baker B, Kowanetz M, et al. Development of a PD-L1 complementary diagnostic immunohistochemistry assay (SP142) for atezolizumab. Appl Immunohistochem Mol Morphol. 2019;27:92-100.

      Vennapusa B, Baker B, Kowanetz M, et al. Development of a PD-L1 complementary diagnostic immunohistochemistry assay (SP142) for atezolizumab. Appl Immunohistochem Mol Morphol. 2019;27:92-100.

    • Data on file. Roche.

      Data on file. Roche.