On April 29, 2016 AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas – respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology – as well as in infection and neuroscience reported financial results for the first quarter ended March 31, 2015 (Press release, AstraZeneca, APR 29, 2016, View Source [SID:1234511729]).

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Total worldwide product sales for the first quarter of 2016 was $ 5,565 million USD in comparison to that of $5,748 million USD for the first quarter of 2015. Total oncology product sales increased from $ 674 million USD in the first of 2015 to $738 million USD in the first quarter of 2016.

Regional sales for the first quarter of 2016 equated to; US – $2,169 m USD, Europe -$1,340 m USD, Established ROW- $706 m USD and Emerging markets – $1,533 m USD. Total regional sales of oncology products were; US- $106 m USD, Europe – $158 m USD, Established ROW – $170 m USD and $240 m USD in Emerging Markets.

For AstraZeneca’s detailed sales figures, visit: View Source

View Source

On April 29, 2016 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the European Union’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the use of Avastin (bevacizumab) in combination with Tarceva (erlotinib) for the first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) activating mutations (Press release, Hoffmann-La Roche , APR 29, 2016, View Source [SID:1234511632]).

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NSCLC is the most common type of lung cancer, the leading cause of cancer-related death in Europe and across the world.1-3 Approximately 10-15 percent of Europeans with NSCLC will have tumours with EGFR-activating mutations, representing an estimated 33,000 cases in Europe per year or 90 every day.1,3-5

"Patients with EGFR mutated lung cancer who were treated with the combination of Avastin plus Tarceva lived significantly longer without their disease progressing compared to patients treated with Tarceva alone." said Sandra Horning, M.D., Chief Medical Officer and Global Head of Product Development. "We are delighted that this strategy of combining targeted medicines has improved patient outcomes. Today’s CHMP opinion brings us one step closer to providing this combination therapy option to patients."

The EU filing was based primarily on data from the pivotal phase II JO25567 study. In the study, patients who received Avastin plus Tarceva lived a median of 6.3 months longer without their disease progres
sing (progression-free survival, PFS) compared to those who received Tarceva alone.5 This represents a statistically significant 46 percent relative reduction in the risk of disease progression or death (median PFS: 16.0 months versus 9.7 months; [HR]=0.54, p=0.0015), meaning the study met its primary endpoint.5 Avastin and Tarceva each target pathways which are known to be key drivers in the growth and development of tumours, and the beneficial effect of Avastin plus Tarceva is supported by results of other clinical studies which showed the combination was effective and tolerable.6,7

About the JO25567 study
JO25567 is a randomised phase II study conducted by Chugai that assessed the safety and efficacy of first-line Avastin in combination with Tarceva compared to Tarceva alone in Japanese patients with non-squamous NSCLC with EGFR-activating mutations. Study data from 154 patients showed:

Patients who received Avastin plus Tarceva lived a median of 6.3 months longer without their disease progressing (progression-free survival, PFS) (primary endpoint) compared to those who received Tarceva alone, representing a statistically significant 46 percent reduction in the relative risk of disease progression or death (median PFS: 16.0 months versus 9.7 months; [HR]=0.54, p=0.0015).5

No new and clinically significant adverse events were observed and the toxicity profile was shown to be managable.5

On April 29, 2016 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the EU Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Gazyvaro (obinutuzumab) in combination with bendamustine chemotherapy followed by Gazyvaro maintenance as a new treatment for people with follicular lymphoma who did not respond to, or who progressed during or up to six months after treatment with MabThera (rituximab) or a MabThera-containing regimen (Press release, Hoffmann-La Roche , APR 29, 2016, View Source [SID:1234511631]).

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Each year, approximately 19,000 people in Europe are diagnosed with follicular lymphoma, the most common type of indolent (slow-growing) non-Hodgkin lymphoma.1,2 Follicular lymphoma is considered incurable, and most people relapse repeatedly.3

"Each time a person with follicular lymphoma experiences a progression of their disease, it becomes harder to treat," said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development. "Progressive disease is particularly challenging after MabThera-containing therapy, and this CHMP positive opinion for Gazyvaro brings us one step closer to providing a much needed new treatment option for follicular lymphoma patients in Europe."

The CHMP’s recommendation is based on results from the phase III GADOLIN study which showed that, in people with follicular lymphoma who did not respond to or who progressed during or within six months of prior MabThera/Rituxan-based therapy, treatment with Gazyva/Gazyvaro plus bendamustine followed by Gazyva/Gazyvaro alone resulted in a 52 percent reduction (HR=0.48, 95 percent CI 0.34-0.68, p<0.0001) in the risk of disease worsening or death (progression-free survival, PFS), compared to bendamustine alone, as evaluated by an independent review committee (IRC). The median PFS was not yet reached in those receiving the Gazyva/Gazyvaro regimen, compared with 13.8 months in those receiving bendamustine alone. As assessed by investigator review, median PFS with the Gazyva/Gazyvaro regimen was more than double that with bendamustine alone (29.2 months vs. 13.7 months; HR=0.48, 95 percent CI 0.35-0.67, p<0.0001).

Based on this positive CHMP recommendation, a final decision regarding the approval of Gazyvaro is expected from the European Commission in the coming months. Gazyvaro is already approved in the EU in combination with chlorambucil for people with previously untreated chronic lymphocytic leukaemia (CLL) and comorbidities that make them unsuitable for full-dose fludarabine based therapy. That approval was based on data from the pivotal CLL11 study, where the combination of Gazyva/Gazyvaro plus chlorambucil showed superior efficacy when compared head-to-head with MabThera/Rituxan plus chlorambucil and chlorambucil alone.

Gazyvaro is marketed as Gazyva outside of the EU and Switzerland. In February 2016, Gazyva received approval by the US Food and Drug Administration in combination with bendamustine followed by Gazyva monotherapy as a treatment for people with follicular lymphoma who did not respond to a Rituxan-containing regimen, or whose follicular lymphoma returned after such treatment, based on the results of the GADOLIN study.

About the GADOLIN study
GADOLIN (NCT01059630; GA04753g) is a phase III open-label, multicentre, randomised two-arm study evaluating Gazyva/Gazyvaro plus bendamustine followed by Gazyva/Gazyvaro alone until disease progression or for up to two years compared to bendamustine alone. GADOLIN included 396 patients with indolent (slow-growing) non-Hodgkin lymphoma (NHL), including 321 patients with follicular lymphoma, whose disease progressed during or within six months of prior MabThera/Rituxan-based therapy. The primary endpoint of the study is progression-free survival (PFS) as assessed by IRC, with secondary endpoints including PFS as assessed by investigator review, best overall response (BOR), complete response (CR), partial response (PR), duration of response, overall survival (OS) and safety profile. Results in follicular lymphoma showed:

The Gazyva/Gazyvaro regimen improved PFS compared to bendamustine alone, as assessed by IRC (HR=0.48, 95 percent CI 0.34-0.68, p<0.0001). Median PFS was not reached in those receiving the Gazyva/Gazyvaro regimen versus 13.8 months in those receiving bendamustine alone.

Investigator-assessed PFS was consistent with IRC-assessed PFS. As assessed by investigator review, median PFS with the Gazyva/Gazyvaro regimen was more than double that with bendamustine alone (29.2 months vs. 13.7 months; HR=0.48, 95 percent CI 0.35-0.67, p<0.0001).

The Gazyva/Gazyvaro regimen reduced the risk of death (OS) by 38 percent compared to bendamustine alone based on a post-hoc analysis eight months after the primary analysis (HR=0.62, 95 percent CI 0.39-0.98). The median OS has not yet been reached in either study arm.

The most common Grade 3-4 adverse events that occurred more often (at least 2 percent or greater) in those receiving the Gazyva/Gazyvaro plus bendamustine regimen compared to those receiving bendamustine alone were low white blood cell count (neutropenia; 33 percent vs. 26 percent), infusion-related reactions (11 percent vs. 6 percent) and urinary tract infection (3 percent vs. 0 percent), respectively.

About Gazyva/Gazyvaro (obinutuzumab)
Gazyva/Gazyvaro is an engineered monoclonal antibody designed to attach to CD20, a protein found only on B-cells. Gazyva/Gazyvaro is designed to attack and destroy targeted B-cells both directly and together with the body’s immune system. Gazyva/Gazyvaro is currently approved in more than 70 countries in combination with chlorambucil, for people with previously untreated chronic lymphocytic leukaemia. The approval was based on the CLL11 study, showing significant improvements with Gazyva/Gazyvaro plus chlorambucil across multiple clinical endpoints, including PFS, overall response rate (ORR), complete response rate (CR), and minimal residual disease (MRD) when compared head-to-head with MabThera/Rituxan plus chlorambucil and chlorambucil alone. Gazyva is approved in the US in combination with bendamustine, for people with follicular lymphoma based on the results of the GADOLIN study. Gazyvaro is marketed as Gazyva outside of the EU and Switzerland.

Gazyva/Gazyvaro is being studied in a large clinical programme, including the phase III GOYA and GALLIUM studies. GOYA is comparing Gazyva/Gazyvaro head-to-head with MabThera/Rituxan plus CHOP chemotherapy in first line diffuse large B-cell lymphoma (DLBCL), and GALLIUM is comparing Gazyva/Gazyvaro plus chemotherapy followed by Gazyva/Gazyvaro maintenance head-to-head with MabThera/Rituxan plus chemotherapy followed by MabThera/Rituxan maintenance in first line indolent non-Hodgkin lymphoma (iNHL). Additional combination studies investigating Gazyva/Gazyvaro with other approved or investigational medicines, including cancer immunotherapies and small molecule inhibitors, are planned or underway across a range of blood cancers.

About Follicular Lymphoma
Follicular lymphoma is the most common indolent (slow-growing) form of non-Hodgkin lymphoma (NHL), accounting for about one in five cases of NHL.1 It is considered incurable and relapse is common. Every year, approximately 19,000 people in Europe are diagnosed with this type of NHL.2 It is estimated that each year more than 75,000 people are diagnosed with follicular lymphoma worldwide.2

On April 29, 2016 Novartis reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Afinitor (everolimus) tablets for the treatment of unresectable or metastatic, well-differentiated (Grade 1 or Grade 2) nonfunctional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin in adults with progressive disease (Press release, Novartis, APR 29, 2016, View Source [SID:1234511628]).

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If approved by the European Commission (EC), Afinitor would address an unmet need as there are currently few or no treatment options in Europe for patients with these diseases.

"This important milestone reinforces our long-standing commitment to the NET community by providing solutions to help improve outcomes for patients with these rare and difficult-to-treat cancers," said Alessandro Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs.

Neuroendocrine tumors are a type of cancer that originate in neuroendocrine cells throughout the body, and most commonly arise in the GI tract, lungs or pancreas[1],[4]. NET can be defined as functional or nonfunctional[5]. The majority of patients with NET (72%) have nonfunctional NET, which are characterized by symptoms caused by tumor growth, such as intestinal obstruction, pain and bleeding for GI NET, and asthma, chronic obstructive pulmonary disease and pneumonia for lung NET[5],[6],[7],[8]. In contrast, functional NET are characterized by symptoms caused by the oversecretion of hormones and other substances[5]. Five to 44% (depending on site of tumor origin) of those with GI NET and 28% of those with lung NET have advanced disease at time of diagnosis, meaning the cancer has spread to other areas of the body and patients face limited treatment options[1],[4]. Progression, or the continued growth or spread of the tumor, is typically associated with poor prognoses[9].

The positive CHMP opinion was based on efficacy and safety data from a pivotal Phase III study (RADIANT-4) showing everolimus reduced the risk of progression in patients with progressive, well-differentiated, nonfunctional, locally advanced or metastatic NET of GI or lung origin by 52% (hazard ratio [HR] = 0.48; 95% confidence interval [CI], 0.35-0.67; p<0.00001) vs placebo. Additionally, the data showed everolimus increased median progression-free survival (PFS) by 7.1 months: median PFS by central review was 11.0 months (95% CI, 9.2-13.3) in the everolimus arm and 3.9 months (95% CI, 3.6-7.4) in the placebo arm[3].

In the pivotal trial, the most common treatment-related grade 3/4 adverse events (AEs) (>=5%) for everolimus and placebo, respectively, were stomatitis (9.0% vs 0.0%), diarrhea (7.0% vs 2.0%) and infections (7.0% vs 0.0%)[1]. The most common treatment-related, all-grade AEs (incidence >=10%) were stomatitis (63%), diarrhea (31%), fatigue (31%), infections (29%), rash (27%) and peripheral edema (26%)[3].

The EC typically adheres to the recommendation of the CHMP and delivers its final decision within three months. The decision will be applicable to all 28 European Union member states plus Iceland and Norway.

In February, the US Food and Drug Administration approved Afinitor for the treatment of adult patients with progressive, well-differentiated, nonfunctional NET of GI or lung origin that are unresectable, locally advanced or metastatic. Additional worldwide regulatory filings for this indication are underway.

RADIANT-4 Study Design
RADIANT-4 (RAD001 In Advanced Neuroendocrine Tumors) is a Phase III prospective, double-blind, randomized, parallel group, placebo-controlled, multicenter study. It examined the efficacy and safety of everolimus plus best supportive care (BSC) vs placebo plus BSC in 302 patients with unresectable, progressive, well-differentiated, nonfunctional, locally advanced or metastatic NET of GI (excluding pancreatic) or lung origin. The primary endpoint of RADIANT-4 was PFS based on independent radiological assessment evaluated by Response Evaluation Criteria in Solid Tumors. Secondary endpoints included overall survival and best overall response rate (defined as complete response plus partial response)[10].

Patients were randomized 2:1 to receive a daily dose of 10 mg everolimus tablets or matching placebo. During treatment, all patients received BSC, which excluded somatostatin analogues (SSAs). Patients had low or intermediate grade histology, no history or active symptoms of carcinoid syndrome, and documented disease progression within the previous 6 months, and were required to have stopped treatment with SSAs for 4 weeks before study entry[10].

The safety profile of everolimus was consistent with what has been observed in previous oncology studies of this drug[10].

About Afinitor (everolimus) tablets
Afinitor (everolimus) tablets is approved in 99 countries, including the US and in the European Union, for locally advanced, metastatic or unresectable progressive NET of pancreatic origin. Afinitor is not indicated for the treatment of patients with functional carcinoid tumors in the US. Afinitor is now approved by the US Food and Drug Administration (FDA) for the treatment of adult patients with progressive, well-differentiated, nonfunctional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin that are unresectable, locally advanced or metastatic.

It is also approved in more than 120 countries including the US and European Union for advanced renal cell carcinoma following progression on or after vascular endothelial growth factor (VEGF)-targeted therapy (in the US, specifically following sunitinib and sorafenib).

Additionally, Afinitor is approved in more than 100 countries including the United States and European Union for advanced HR+/HER2- breast cancer in combination with exemestane, after prior endocrine therapy.

Everolimus is also available from Novartis for use in certain non-oncology patient populations under the brand names Afinitor or Votubia, Certican and Zortress and is exclusively licensed to Abbott and sublicensed to Boston Scientific for use in drug-eluting stents.

Indications vary by country and not all indications are available in every country. The safety and efficacy profile of everolimus has not yet been established outside the approved indications. Because of the uncertainty of clinical trials, there is no guarantee that everolimus will become commercially available for additional indications anywhere else in the world.

Important Safety Information about Afinitor (everolimus) tablets
Afinitor/Votubia can cause serious side effects including lung or breathing problems, infections (including sepsis), and kidney failure, which can lead to death. Patients taking concomitant angiotensin-converting enzyme (ACE) inhibitors may be at an increased risk for angioedema. Mouth ulcers and mouth sores are common side effects. Afinitor/Votubia can affect blood cell counts, kidney and liver function, and blood sugar, cholesterol, and triglyceride levels. Afinitor/Votubia may cause fetal harm in pregnant women. Highly effective contraception is recommended for women of child-bearing potential while receiving Afinitor/Votubia and for up to eight weeks after ending treatment. Women taking Afinitor/Votubia should not breast feed. Fertility in women and men may be affected by treatment with Afinitor/Votubia.

The most common adverse drug reactions (incidence >=10 percent) are mouth ulcers, skin rash, feeling tired or weak, diarrhea, infections (including upper respiratory tract infection, sore throat and runny nose, sinusitis, middle ear infection and pneumonia), absence of menstrual periods, high levels of cholesterol, nausea, decreased appetite, low level of red blood cells, acne, abnormal taste, irregular menstrual periods, inflammation of lung tissue, swelling of extremities or other parts of the body, high level of blood sugar, itching, weight loss, nose bleeds, cough and headache. The most common grade 3-4 adverse drug reactions (incidence >=2 percent) are mouth ulcers, infections (including pneumonia), low level of red blood cells, absence of menstrual periods, high level of blood sugar, feeling tired or weak, diarrhea, low white blood cells, inflammation of lung tissue and spontaneous bleeding or bruising. Cases of hepatitis B reactivation, blood clots in the lung or legs, and pneumocystis jirovecii pneumonia (PJP) have been reported. Abnormalities were observed in hematology and clinical chemistry laboratory tests.

On April 29, 2016 Janssen-Cilag International NV reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a Positive Opinion, recommending broadening the existing marketing authorisation for ibrutinib as a single agent for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (Press release, Johnson & Johnson, APR 29, 2016, View Source [SID:1234511627]).

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Ibrutinib is approved for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL), or adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy, or in first line in the presence of 17p deletion or TP53 mutation (genetic mutations typically associated with poor treatment outcomes) in patients unsuitable for chemo-immunotherapy and in adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.1

The Positive Opinion of the CHMP was based on data from the Phase 3, randomised, open-label RESONATE-2 (PCYC-1115) clinical trial, as recently published in The New England Journal of Medicine (NEJM).2 Findings showed ibrutinib provided a significant improvement in all efficacy endpoints versus chlorambucil in patients aged 65 or older with newly diagnosed CLL. The progression-free survival (PFS) rate at 18 months was 90 percent for ibrutinib versus 52 percent for chlorambucil.2 Ibrutinib also significantly prolonged overall survival (OS) (HR=0.16 percent CI, 0.05, 0.56; P=0.001), with a 24-month survival rate of 98 percent, compared to 85 percent for patients in the chlorambucil arm.2 The safety of ibrutinib in the treatment-naïve CLL patient population was consistent with previously reported studies.2 The most common adverse reactions (ARs) (≥20 percent) of any Grade in the RESONATE-2 trial for ibrutinib were diarrhoea (42 percent), fatigue (30 percent), cough (22 percent) and nausea (22 percent).2

CLL is a chronic disease, and the prevalence rate in Europe among men and women is approximately 5.87 and 4.01 cases per 100,000 persons per year, respectively. Median overall survival ranges between 18 months and more than 10 years according to the stage of disease.3

"Janssen is proud to be leading the charge with our ongoing efforts to transform the treatment experience for patients with difficult to treat blood cancers, such as CLL," said Jane Griffiths, Company Group Chairman, Janssen Europe, Middle East and Africa. "Ibrutinib continues to demonstrate impressive clinical results, and the data on which this recommendation is based once again highlight its potential to deliver improved patient outcomes for suitable patients."

This regulatory milestone follows the decision by the U.S. Food and Drug Administration on 04 March 2016, to approve the expanded use of ibrutinib capsules for treatment-naïve patients with CLL.

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.4 By blocking this BTK protein, ibrutinib helps kill and reduce the number of cancer cells. It also slows down the progression of the cancer.1

Ibrutinib is currently approved in Europe for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL); adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy, or in first line patients with CLL in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy; and in adult patients with Waldenström’s macroglobulinemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy.5 Regulatory approval for additional uses has not yet been granted. Investigational uses for ibrutinib, alone and in combination with other treatments, are underway in several blood cancers.

Ibrutinib is co-developed by Cilag GmbH International, a member of the Janssen Pharmaceutical Companies, and Pharmacyclics LLC, an AbbVie company. Janssen affiliates market ibrutinib in EMEA (Europe, Middle East and Africa) as well as the rest of the world, except in the United States, where Janssen Biotech, Inc. and Pharmacyclics co-market it. Janssen and Pharmacyclics are continuing an extensive clinical development programme for ibrutinib, including Phase 3 study commitments in multiple patient populations – please see the ibrutinib summary of product characteristics for further information.

About RESONATE-2

Findings of the RESONATE-2 (PCYC-1115) trial showed ibrutinib provided a significant improvement in progression-free survival and other key clinical endpoints versus chlorambucil in patients aged 65 or older with newly diagnosed CLL. The progression-free survival (PFS) rate at 18 months was 90 percent for ibrutinib versus 52 percent for chlorambucil.2 Ibrutinib also significantly prolonged overall survival (OS) (HR=0.16 percent CI, 0.05, 0.56; P=0.001), with a 24-month survival rate of 98 percent, compared to 85 percent for patients in the chlorambucil arm.2

The safety of ibrutinib in the previously untreated CLL patient population was consistent with previously reported studies.2,5 The adverse reactions (AR) reported in the RESONATE-2 trial reflect exposure to ibrutinib with a median duration of 17.4 months versus a median exposure to chlorambucil of 7.1 months: nearly 2.5 times longer exposure for ibrutinib.2 The most common non-haematological ARs of Grade ≥3 were pneumonia, hypertension and diarrhoea (all 4 percent).2

About CLL

In most patients, CLL is generally a slow-growing blood cancer of the white blood cells called B-lymphocytes.6 The median age at diagnosis is 72 years,7 and incidence rates among men and women in Europe are approximately 5.87 and 4.01 cases per 100,000 persons per year, respectively.8 CLL is a chronic disease; median overall survival ranges between 18 months and more than 10 years according to the stage of disease.3 The disease eventually progresses in the majority of patients, and patients are faced with fewer treatment options each time. Patients are often prescribed multiple lines of therapy as they relapse or become resistant to treatments.