On December 5, 2018 The Janssen Pharmaceutical Companies of Johnson & Johnson reported new results from three key studies of IMBRUVICA (ibrutinib) in chronic lymphocytic leukaemia (CLL), a difficult-to-treat form of blood cancer and the most common form of leukaemia in adults (Press release, Johnson & Johnson, DEC 5, 2018, View Source [SID1234531913]).1 Findings were presented at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, taking place in San Diego, CA.

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Results from the National Cancer Institute (NCI)-sponsored Phase 3 study (E1912) led by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) were presented during the Late-Breaker abstract oral session. The study evaluated ibrutinib plus rituximab compared to a chemotherapy regimen of fludarabine, cyclophosphamide, and rituximab (FCR) in previously untreated patients aged 70 years or younger with CLL. With nearly three years of follow-up, the data showed ibrutinib plus rituximab significantly prolonged progression-free survival (PFS) and overall survival (OS) versus FCR.2

Data from the Phase 3 iLLUMINATE (PCYC-1130) study were also presented in an oral session and simultaneously published in The Lancet Oncology. Findings showed the combination of ibrutinib plus obinutuzumab significantly improved PFS versus chlorambucil plus obinutuzumab in patients with newly diagnosed CLL.3 These data recently supported the submission of a Type II variation application to the European Medicines Agency (EMA), seeking approval for the expanded use of ibrutinib in combination with obinutuzumab in previously untreated adults with CLL.

In addition, ibrutinib data from the Phase 1b/2 study and its extension study (PCYC-1102, PCYC-1103) with up to seven years of follow-up in patients with newly diagnosed and relapsed/refractory (R/R) CLL, demonstrated durable, long-term survival benefits as a monotherapy, representing the longest follow-up for a Bruton’s tyrosine kinase (BTK) inhibitor in CLL.4

"Findings from both iLLUMINATE and the ECOG-ACRIN study demonstrate impressive prolonged progression-free survival for the relevant ibrutinib-based combinations, versus commonly used chemo-immunotherapy regimens," said Dr Carol Moreno, Consultant Haematologist, Hospital de la Santa Creu Sant Pau, Autonomous University of Barcelona, Barcelona, Spain. "These non-chemotherapy regimens present an advance in how we might consider the management of patients, including younger patients and those with high risk CLL features with potential to address the trade-off between efficacy and toxicity for patients."

"The data presented at ASH (Free ASH Whitepaper) provide further convincing evidence of the clinical benefit ibrutinib can offer to patients across the spectrum of CLL management. The long-term data also offer confidence of its sustained activity for patients," said Dr Catherine Taylor, Haematology Therapy Area Lead, Europe, Middle East and Africa (EMEA), Janssen-Cilag Limited. "We continue to explore the full potential of ibrutinib through a comprehensive clinical development programme, to improve outcomes and change what a blood cancer diagnosis means to patients."

Ibrutinib, a first-in-class BTK inhibitor, is jointly developed and commercialised by Janssen Biotech, Inc., and Pharmacyclics LLC, an AbbVie company.

Results From the Randomised Phase 3 Study of Ibrutinib (PCI-32765)-Based Therapy vs. FCR Chemoimmunotherapy in Untreated Younger Patients with CLL: A Study of the ECOG-ACRIN Cancer Research Group (E1912) (Abstract #LBA-4)

With a median follow-up of 33.4 months, the interim analysis observed 77 PFS events and 14 deaths. Ibrutinib plus rituximab significantly improved PFS compared to FCR (HR: 0.352; 95 percent confidence interval [CI]: 0.223-0.558; p<0.0001); the pre-specified boundary for PFS was crossed. The ibrutinib plus rituximab treatment arm also showed improved OS (HR: 0.168; 95 percent CI: 0.053-0.538; p=0.0003, pre-specified boundary for superiority p=0.0005).2

In a subgroup analysis for PFS, ibrutinib plus rituximab showed prolonged PFS independent of age, sex, performance status, disease stage, or the presence/absence of the cytogenetic abnormality, deletion 11q23. With current follow-up, ibrutinib plus rituximab was also superior to FCR for IGHV unmutated patients (HR: 0.262; 95 percent CI: 0.137-0.498; p<0.0001) but not IGHV mutated patients (HR: 0.435; 95 percent CI: 0.140-0.1350; p=0.07).2

Grade 3/4 treatment-related adverse events (AEs) were observed in 58 percent of ibrutinib plus rituximab treated patients and 72 percent of FCR treated patients (p=0.0042). FCR was more frequently associated with Grade 3 and 4 neutropenia (FCR: 44 percent vs. ibrutinib plus rituximab: 23 percent; p<0.0001) and infectious complications (FCR: 17.7 percent vs. ibrutinib plus rituximab: 7.1 percent; p<0.0001).2

Results from the Phase 3 iLLUMINATE study (Abstract #691)

At a median follow-up of 31.3 months, ibrutinib plus obinutuzumab significantly prolonged the Independent Review Committee (IRC)-assessed PFS compared with chlorambucil plus obinutuzumab (median not reached [NR] vs. 19.0 months; HR 0.231; 95 percent CI: 0.145-0.367; p<0.0001), with a 77 percent reduction in risk of progression or death.3

Superior PFS in the ibrutinib plus obinutuzumab arm compared to the chlorambucil plus obinutuzumab arm was also seen in the high-risk population, including those with unmutated IGHV, del11q, del17p and/or TP53 mutation, with an 85 percent reduction in risk of progression or death (median NR vs. 14.7 months; HR 0.154; 95 percent CI: 0.087-0.270; p<0.0001).5 In addition, IRC-assessed overall response rate (ORR) was higher in the ibrutinib plus obinutuzumab arm versus the chlorambucil plus obinutuzumab arm (88 percent vs. 73 percent); complete response (CR)/complete response with incomplete blood recovery (CRi) rates were also higher with 19 percent versus eight percent, respectively. Minimal residual disease (MRD) was undetectable in blood and/or bone marrow (<10-4 by flow cytometry) for 35 percent of patients treated with ibrutinib plus obinutuzumab, compared to 25 percent of patients treated with chlorambucil plus obinutuzumab. OS rates at 30 months were 86 percent for the ibrutinib plus obinutuzumab arm compared to 85 percent for the chlorambucil plus obinutuzumab arm.3

The most common Grade 3 or higher AEs in the ibrutinib plus obinutuzumab arm versus chlorambucil plus obinutuzumab arm were neutropenia (36 percent vs. 46 percent), thrombocytopenia (19 percent vs. 10 percent), pneumonia (7 percent vs. 4 percent), atrial fibrillation (5 percent vs. 0 percent), febrile neutropenia (4 percent vs. 6 percent), anaemia (4 percent vs. 8 percent) and infusion-related reactions (IRRs; 2 percent vs. 8 percent).5 No patients discontinued obinutuzumab due to IRRs in the ibrutinib plus obinutuzumab arm compared to the chlorambucil plus obinutuzumab arm (6 percent). AEs led to the discontinuation of ibrutinib in 16 percent of patients and led to the discontinuation of chlorambucil in nine percent of patients. AEs led to the discontinuation of obinutuzumab in the ibrutinib plus obinutuzumab arm (9 percent) and chlorambucil plus obinutuzumab arm (13 percent). With about three years of follow-up, 70 percent of patients in the ibrutinib plus obinutuzumab arm remain on ibrutinib monotherapy.3

Results from up to seven years of follow-up in the Phase 1b/2 PCYC-1102 study and its extension, PCYC-1103 (Abstract #3133)

Results from these studies showed durable efficacy of ibrutinib in newly diagnosed and R/R CLL patients. These long-term data showed sustained PFS and OS rates. The estimated seven-year PFS rates were 80 percent for patients with newly diagnosed disease and 32 percent for patients with R/R disease. Notably, administering ibrutinib in earlier lines of therapy resulted in improved PFS outcomes for R/R patients.4

ORR was 89 percent for all patients (CR, 15 percent), with similar rates in newly diagnosed (87 percent [CR, 32 percent]) and R/R CLL patients (89 percent [CR, 10 percent]). Median duration of response (DOR) was NR (95 percent CI: 0+-85+) for newly diagnosed CLL patients and was 57 months (95 percent CI: 0+-85+) for R/R CLL patients.6 Median PFS was NR (95 percent CI: not estimable [NE], NE) for newly diagnosed CLL patients and was 51 months (95 percent CI: 37-70) for R/R CLL patients.4,6 The median OS was NR in newly diagnosed (95 percent CI: 80-NE) or R/R CLL patients (95 percent CI: 63-NE), with estimated seven-year OS rates of 75 percent and 52 percent, respectively.4

Grade 3 or higher AEs were reported in 74 percent of newly diagnosed and 89 percent of R/R patients with CLL. Hypertension (newly diagnosed, 32 percent; R/R, 26 percent), diarrhoea (newly diagnosed, 16 percent; R/R, 4 percent), and hyponatraemia (newly diagnosed, 10 percent; R/R, 0 percent) were among the most common Grade 3 or higher treatment-emergent AEs. Major haemorrhage and Grade 3 or higher atrial fibrillation, thrombocytopenia, anaemia, and arthralgia were observed in 11 percent or less of newly diagnosed and R/R patients. In addition, infection (newly diagnosed, 23 percent; R/R, 55 percent) was more common in R/R CLL patients.6 No new or unexpected AEs were observed, and the occurrence of most Grade 3 or higher AEs and serious AEs decreased over time, with the exception of hypertension.6

#ENDS#

About the ECOG-ACRIN E1912 study

The Phase 3 study (E1912) evaluated previously untreated patients with CLL aged 70 years or younger, who were randomly assigned to receive ibrutinib (420 mg/day until disease progression) and rituximab (50 mg/m2 on day 1 of cycle 2; 325 mg/m2 on day 2 of cycle 2; 500 mg/m2 on day 1 of cycles 3-7) (n=354) or six courses of intravenous fludarabine (25 mg/m2) and cyclophosphamide (250 mg/m2) days 1-3 with rituximab (50 mg/m2 on day 1 of cycle 1; 325 mg/m2 on day 2 of cycle 1; 500 mg/m2 on day 1 of cycles 2-6) every 28-days (n=175). The primary endpoint was PFS with a secondary endpoint of OS.2

The federally funded study was designed by researchers with ECOG-ACRIN. It was conducted through the NCI’s National Clinical Trials Network. Pharmacyclics LLC provided ibrutinib under a cooperative research and development agreement with NCI and a separate agreement with ECOG-ACRIN.

About the iLLUMINATE study

iLLUMINATE (PCYC-1130) evaluated newly diagnosed CLL patients who were randomised to receive ibrutinib 420 mg once-daily continuously until disease progression or unacceptable toxicity in combination with obinutuzumab 1000 mg intravenously over six cycles (n=113); or chlorambucil on Days 1 and 15 of each cycle plus obinutuzumab 1000 mg intravenously over 6 cycles (n=116). Median age of the patients was 71 years and 65 percent of the patients had high-risk genomic features. The primary endpoint was PFS, as assessed by an Independent Review Committee. Secondary endpoints included PFS in a high-risk population, rate of undetectable MRD, ORR, OS, and safety.3

About PCYC-1102 and PCYC-1103

With up to seven years of follow-up, the studies (Phase 1b/2, PCYC-1102 and its extension, PCYC-1103) evaluated newly diagnosed and R/R CLL patients (n=132; newly diagnosed=31, R/R=101), including those with high-risk features, who received 420 mg or 840 mg once-daily ibrutinib until disease progression or unacceptable toxicity. As of the cutoff, 55 percent of newly diagnosed and 21 percent of R/R patients continued ibrutinib, with median follow-up of 67 months.4

About ibrutinib

Ibrutinib is a first-in-class Bruton’s tyrosine kinase (BTK) inhibitor, which works by forming a strong covalent bond with BTK to block the transmission of cell survival signals within the malignant B-cells.7 By blocking this BTK protein, ibrutinib helps kill and reduce the number of cancer cells, thereby delaying progression of the cancer.8

Ibrutinib is currently approved in Europe for the following uses:9

Chronic lymphocytic leukaemia (CLL): As a single agent for the treatment of adult patients with previously untreated CLL, and as a single agent or in combination with bendamustine and rituximab (BR) for the treatment of adult patients with CLL who have received at least one prior therapy.
Mantle cell lymphoma (MCL): Adult patients with relapsed or refractory mantle cell MCL.
Waldenström’s macroglobulinemia (WM): Adult patients who have received at least one prior therapy or in first-line treatment for patients unsuitable for chemo-immunotherapy.
Ibrutinib is approved in more than 90 countries, and, to date, has been used to treat more than 135,000 patients worldwide across its approved indications.10

The most common adverse reactions seen with ibrutinib include diarrhoea, neutropenia, haemorrhage (e.g., bruising), musculoskeletal pain, nausea, rash, and pyrexia.9

For a full list of side effects and information on dosage and administration, contraindications and other precautions when using ibrutinib please refer to the Summary of Product Characteristics for further information.

On December 5, 2018 Janssen Pharmaceuticals of Johnson & Johnson reported the updated results of Legend Biotech Inc.’s LEGEND-2 phase 1/2 open-label study, which evaluated the experimental multi-cell experimental chimeric antigen receptor T ( CAR-T) LCAR-B38M in the treatment of patients with recurrent or refractory advanced multiple myeloma (R / R) (Press release, Johnson & Johnson, DEC 5, 2018, View Source [SID1234531912]). These results, presented in an oral presentation at the 2018 Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) (Abstract # 955 ), 1 based on data from one of the four independent institutional studies of Xi’an Jiaotong Second Affiliated Hospital, which were originally presented at the 2017 Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2 and at the 2017 Annual Congress of the European Association of Hematology (EHA) (Free EHA Whitepaper). 3 These updated results have shown that B-cell maturation antigen-directed (BACM) CAR-T cell-mediated CLAR-B38M therapy has resulted in profound, long-lasting responses with a manageable and tolerable safety profile. in patients who failed a median of three previous treatments. 1

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"The science of CAR-T has led to the approval of essential therapeutic interventions for certain blood cancers, and we hope that the results we see for multiple myeloma will provide an additional option so much hoped for by patients," said Dr. Wan-Hong Zhao, Associate Director of Hematology at the Second Affiliated Hospital of Xi’an Jiaotong University in Xi’an, China, and Principal Investigator of the Study We are excited about this data and the fact that they have demonstrated remarkable responses in heavily pretreated patients with multiple myeloma, a population that is traditionally difficult to treat. "

As part of this update of the study, 57 patients with advanced multiple myeloma R / R received cell therapy CAR-T-LCAR B38M. The median age of the patients was 54 (range: 27 to 72 years); the median number of previous treatments was three (range 1-9); and 74% of patients were in stage III of the disease according to the Durie-Salmon classification. 1 The results of the study, the overall response rate was 88% (confidence interval [95% CI]. 76-95 A complete response (CR) was achieved in 74% of patients (95% IC, 60-85), a very good partial response was obtained in 4% of patients (2/57 patients; 95% CI, 0.4 to 12) and a partial response in 11% of patients (95 %, 4-22). 4 It should be noted that of the 42 patients who achieved RC, 39 patients (68%) had negative MRD (minimal residual disease) in the bone marrow as measured by flow cytometry to 8 colors. With a median follow up of 12 months, the median duration of response was 16 months (95% CI: 12 not met [NR]), and a median progression free survival (PFS) 15 months was observed in all patients . In patients with negative MRD, the median PFS was 24 months. 1

The most common adverse events (AEs) were pyrexia (91%), cytokine release syndrome (CRS) (90%), thrombocytopenia (49%) and leukopenia (47%). Grade ≥ 3 adverse events (65%), the most common were leukopenia (30%), thrombocytopenia (23%) and an increase in aspartate aminotransferase (21%). 4 The CRS was mainly grade 1 (47%) and 2 (35%). However, four patients (7%) had a CRS grade 3. The median time to onset of CRS was nine days (range: 1 to 19). All CRS cases except one were resolved within a median of nine days (range: 3-57). Neurotoxicity was observed in one patient who experienced aphasia, agitation, and grade 1 seizure-related activity. A total of 17 patients died during the study and follow-up period; causes of death were progressive disease (ME, n = 14), suicide after EM (n = 1), esophagitis (n = 1), pulmonary embolism and acute coronary syndrome (n = 1) . 1

Janssen has a long-standing commitment to improving outcomes for patients with multiple myeloma, so this early data is encouraging about the potential difference this experimental treatment could make for patients with recurrent or refractory disease. Dr. Catherine Taylor, Head of Hematology Therapy Division, Europe, Middle East and Africa (EMEA) at Janssen-Cilag Limited, will continue to study the safety and efficacy profile of this important BCMA-targeted immunotherapy to understand the potential role it could play as a new approach to treating patients with multiple myeloma. "

In December 2017, Janssen entered into a worldwide collaboration and license agreement with Legend Biotech, USA Inc, and Legend Biotech Ireland Limited ("Legend"), subsidiaries of GenScript Biotech Corporation, to jointly develop and commercialize the LCAR- B38M for the treatment of multiple myeloma. 5 LCAR B38M-CAR is a T-cell therapy directed against two distinct epitopes BCMA, which confers a high avidity and affinity binding of the compound to cells expressing BCMA. 1 In China, a Phase 2 confirmatory trial with the Center for Drug Evaluation (CTR20181007) is being planned to further evaluate LCAR-B38M in patients with advanced R / R multiple myeloma.

While "LCAR-B38M" refers to the experimental product studied in China, the investigational product studied in the United States and the European Union is identified under the reference "JNJ-68284528"; both terms represent the same CAR-T therapy. Janssen and Legend jointly conduct a global Phase 1b / 2 ( NCT03548207 ) trial of JNJ-68284528 to evaluate its efficacy and safety in adults with advanced R / R multiple myeloma. 6 The study is currently recruiting patients following approval by the US Food and Drug Administration of an application for a new investigational drug, as announced in May 2018. 7

About LEGEND-2

LEGEND-2 ( NCT03090659 ) is a single-phase, open – label, one-to-one program implemented in China that includes four independent institutional studies conducted in participating hospitals to evaluate the efficacy and safety of LCAR-B38M in the community. treatment of patients with R / R multiple myeloma. 8

About CAR-T and BCMA

CAR-T cells are an innovative approach to eradicate cancer cells by harnessing the power of the patient’s immune system. BCMA is a protein strongly expressed in myeloma cells. 9 By targeting the BCMA via CAR-T approach, CAR-T therapies could potentially redefine the multiple myeloma treatment paradigm and potentially progress to curative treatments for patients with this disease.

About multiple myeloma

Multiple myeloma (MM) is an incurable blood cancer that originates in the bone marrow and is characterized by excessive proliferation of plasma cells. 10 In 2016, a diagnosis of MM was made in more than 45,000 people in Europe and more than 29,000 patients died. 11 For half of newly diagnosed patients, the survival rate does not exceed five years, 12 and nearly 29% of MM patients die within one year of diagnosis. 13

Although treatment may offer remission, recurrence is unfortunately likely because there is currently no cure. 14 MM is refractory when the disease develops within 60 days of the patient’s last treatment. 15,16 Recurrent cancer is when the disease recurs after a period of initial, partial or complete remission. 17 While some MM patients have no symptoms, most patients are diagnosed with symptoms that may include bone problems, low blood counts, elevated calcium levels, kidney problems, or infections. 18 The prognosis of patients who relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents, is poor and there are few treatment options. 19

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On December 5, 2018 Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a biopharmaceutical company focused on developing and commercializing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, reported that President and Chief Executive Officer Guy Macdonald will present a corporate overview at the BMO Prescriptions for Success Healthcare Conference on Wednesday, December 12, 2018 at 9:40 a.m. ET at the Mandarin Oriental Hotel in New York City (Press release, Tetraphase, DEC 5, 2018, View Source [SID1234531909]).

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A live audio webcast of the BMO Prescriptions for Success Healthcare Conference presentation will be available on the Company’s website at View Source The archived presentation will be available for 30 days.

On December 5, 2018 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq (atezolizumab), in combination with carboplatin and etoposide (chemotherapy), for the initial (first-line) treatment of people with extensive-stage small cell lung cancer (ES-SCLC) (Press release, Genentech, DEC 5, 2018, View Source [SID1234531908]). The FDA is expected to make a decision on approval by March 18, 2019. A Priority Review designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a serious disease.

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"It’s been more than 20 years since there has been a new initial treatment option for extensive-stage small cell lung cancer that delivers a clinically meaningful survival benefit," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "We are working closely with the FDA to bring this Tecentriq-based regimen to people with this difficult-to-treat type of lung cancer as soon as possible."

This sBLA is based on results from the Phase III IMpower133 study, which met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS) in the initial treatment of people with ES-SCLC. The safety profile of the combination was consistent with the safety profiles of the individual medicines, and no new safety signals were identified.

Tecentriq is currently approved by the FDA to treat people with metastatic non-small cell lung cancer (NSCLC) who have disease progression during or following platinum-containing chemotherapy, and have progressed on an appropriate FDA-approved targeted therapy if their tumor has ALK or EGFR gene abnormalities.

About the IMpower133 study

IMpower133 is a Phase III, multicenter, double-blinded, randomized placebo-controlled study evaluating the efficacy and safety of Tecentriq in combination with chemotherapy (carboplatin and etoposide) versus chemotherapy (carboplatin and etoposide) alone in chemotherapy-naïve people with ES-SCLC. The study enrolled 403 people who were randomized equally (1:1) to receive:

Tecentriq in combination with carboplatin and etoposide (Arm A), or
Placebo in combination with carboplatin and etoposide (Arm B, control arm)
During the treatment-induction phase, people received treatment on 21-day cycles for four cycles, followed by maintenance with Tecentriq or placebo until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment could be continued until persistent radiographic PD or symptomatic deterioration was observed.

The co-primary endpoints were:

PFS as determined by the investigator using RECIST v1.1 in the intention-to-treat (ITT) population
OS in the ITT population
IMpower133 met its OS and PFS co-primary endpoints as per the study protocol. The analysis showed that Tecentriq and chemotherapy helped people live significantly longer compared to chemotherapy alone (OS=12.3 versus 10.3 months; hazard ratio [HR] = 0.70, 95 percent CI: 0.54-0.91; p=0.0069) in the ITT population. The one-year OS rate for people who received the Tecentriq-based combination was 51.7 percent compared to 38.2 percent for people who received chemotherapy alone. The Tecentriq-based combination also significantly reduced the risk of disease worsening or death compared to chemotherapy alone (PFS=5.2 versus 4.3 months; HR=0.77; 95 percent CI: 0.62-0.96; p=0.017). The one-year PFS rate for people who received the Tecentriq-based combination was 12.6 percent compared to 5.4 percent for people who received chemotherapy alone. Safety for the Tecentriq and chemotherapy combination appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination. Grade 3-4 treatment-related adverse events (AEs) were reported in 56.6 percent of people receiving Tecentriq plus chemotherapy compared to 56.1 percent of people receiving chemotherapy alone.

About lung cancer

According to the American Cancer Society, it is estimated that more than 234,000 Americans will be diagnosed with lung cancer in 2018. Lung cancer can be broadly divided into two major types: non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). NSCLC is the most prevalent type, accounting for around 85 percent of all lung cancer cases, and SCLC accounting for approximately 15 percent of all cases. The majority (approximately 70 percent) of people with SCLC are diagnosed with ES-SCLC.

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. Indication (pronounced ‘tē-SEN-trik’)

Tecentriq is a prescription medicine used to treat:

A type of bladder and urinary tract cancer called urothelial carcinoma.

Tecentriq may be used when your bladder cancer:
has spread or cannot be removed by surgery, and if you have any one of the following conditions:
you are not able to take chemotherapy that contains a medicine called cisplatin, and your doctor has tested your cancer and found high levels of a specific protein on your cancer called programmed death-ligand 1 (PD-L1), as determined by an FDA-approved test, or
you are not able to take chemotherapy that contains any platinum regardless of PD-L1 status on your cancer, or
you have tried chemotherapy that contains platinum, and it did not work or is no longer working
The approval of Tecentriq in these patients is based on a study that measured response rate and duration of response. There is an ongoing study to confirm clinical benefit.

A type of lung cancer called non-small cell lung cancer (NSCLC).

Tecentriq may be used when your lung cancer:
has spread or grown, and
you have tried chemotherapy that contains platinum, and it did not work or is no longer working
If your tumor has an abnormal EGFR or ALK gene, you should have also tried an FDA-approved therapy for tumors with these abnormal genes, 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

What is the most important information about Tecentriq?

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 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 may include new or worsening cough, shortness of breath, and 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, and 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 or mucous in the stools or dark, tarry, sticky stools, and severe stomach area (abdomen) pain or tenderness
Hormone gland problems (especially the thyroid, adrenal glands, pancreas, and pituitary)–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, the voice gets deeper, urinating more often than usual, nausea or vomiting, and stomach area (abdomen) pain
Problems in other organs–signs and symptoms may include severe muscle weakness, numbness or tingling in hands or feet, confusion, blurry vision, double vision, or other vision problems, changes in mood or behavior, extreme sensitivity to light, neck stiffness, eye pain or redness, skin blisters or peeling, chest pain, irregular heartbeat, shortness of breath, or swelling of the ankles
Severe infections–signs and symptoms of infection may include fever, cough, flu-like symptoms, pain when urinating, and frequent urination or back pain
Severe infusion reactions–signs and symptoms of infusion reactions may include chills or shaking, itching or rash, flushing, shortness of breath or wheezing, swelling of the face or lips, dizziness, fever, feeling like passing out, and back or neck pain
Getting medical treatment right away may help keep these problems from becoming more serious. A healthcare provider may treat patients with corticosteroid or hormone replacement medicines. A healthcare provider may delay or completely stop treatment with Tecentriq if patients have severe side effects.

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. 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. If patients 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. Do not breastfeed during treatment and for at least 5 months after the last dose of Tecentriq
Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of Tecentriq in people with urothelial carcinoma include:

feeling tired
decreased appetite
nausea
constipation
urinary tract infection
diarrhea
fever
The most common side effects of Tecentriq in people with non-small cell lung cancer include:

feeling tired
decreased appetite
muscle pain
cough
shortness of breath
Tecentriq may cause fertility problems in females, which may affect the ability to have children. Patients should talk to their healthcare provider if they have concerns about fertility.

These are not all the possible side effects of Tecentriq. Patients should ask their healthcare provider or pharmacist for more information. Patients should call their doctor for medical advice about side effects.