Global cancer cases reach 14 million, World Health Organization says

The number of people being diagnosed with cancer in the world each year has leaped to more than 14 million, the World Health Organization says.

The data for 2012 shows a marked rise on the 12.7 million cases in 2008.

In that time the number of deaths has also increased, from 7.6 million to 8.2 million.

The rising burden of cancer is being driven by a rapid shift in lifestyles in the developing world to more closely reflect industrialised countries.

Rising rates of smoking and obesity as well as people living longer are contributing to the rise.

Lung cancer, which is mainly caused by smoking, was the most common cancer globally, with 1.8 million cases – about 13% of the total.

The WHO also described a « sharp rise » in cases of breast cancer. Both the incidence and mortality have increased since 2008. The disease in now the most common cancer in women in 140 countries.

Dr David Forman, from the WHO’s International Agency for Research on Cancer, said: « Breast cancer is also a leading cause of cancer death in the less developed countries of the world.

« This is partly because a shift in lifestyles is causing an increase in incidence, and partly because clinical advances to combat the disease are not reaching women living in these regions. »

The WHO said there was an « urgent need » for the advances made in detection, diagnoses and treatment of breast cancer to be implemented in developing nations.

The WHO predicts the number of cancer cases will soar to more than 19 million a year by 2025

Pfizer And GSK To Initiate Study Of Novel Combination Therapy In Patients With Melanoma

Pfizer Inc. announced that it has entered into an agreement with GSK to explore the anti-cancer efficacy and the safety of GSK’s trametinib (GSK1120212) combined with Pfizer’s palbociclib (PD-0332991) in a Phase I/II study (Study 200344) in patients with advanced/metastatic melanoma.

Study 200344 is a dose-escalation, open-label study designed to determine the recommended combination regimen (RCR) for trametinib plus palbociclib in patients with melanoma.  The study will also evaluate the effect of the combination on tumor biomarkers, safety and anti-cancer activity in patients with BRAFV600 wild type melanoma, including those with NRAS mutations.

“Pfizer Oncology is committed to maximizing the value of our portfolio for patients through the study of novel combinations.  This includes combining our own cancer medicines with each other, as well as with those of other companies where there is strong scientific rationale,” said Garry Nicholson, president and general manager, Pfizer Oncology Business Unit.  “Emerging data suggest the potential for trametinib and palbociclib to work together to treat melanoma.  We look forward to collaborating with GSK to explore this potential and evaluate the clinical activity of this combination in melanoma.”

The two companies will collaborate on the study, which GSK will conduct.  Financial terms of the agreement were not disclosed.

Trametinib, a reversible inhibitor of MEK1 and MEK2, is approved by the U.S. Food and Drug Administration (FDA) under the name Mekinist® for the treatment of adult patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutation as detected by an FDA-approved test.  Mekinist is not indicated for the treatment of patients who have received a prior BRAF inhibitor therapy.

Palbociclib is an investigational oral and selective inhibitor of cyclin dependent kinases (CDK) 4 and 6.  In April 2013, palbociclib received Breakthrough Therapy designation by the FDA for the potential treatment of patients with breast cancer. Palbociclib is not approved for any indication in any markets.

Source: Pfizer

FDA clears Bayer, Onyx Pharmaceuticals’ Nexavar for late-stage differentiated thyroid cancer

The FDA on Friday approved Bayer and Onyx Pharmaceuticals’ Nexavar (sorafenib) for the treatment of patients with late-stage differentiated thyroid cancer. Pamela A. Cyrus, head of US medical affairs for Bayer, remarked « Nexavar is the first and only FDA-approved therapy for this type of thyroid cancer and is a positive development for patients who previously had limited treatment options. »

The approval was supported by a study involving 417 patients with radioactive iodine-refractory locally recurrent or metastatic, progressive differentiated thyroid cancer. Study data showed that the therapy extended progression-free survival by 41 percent, as patients treated with Nexavar displayed a progression-free survival of 10.8 months, versus 5.8 months for the placebo arm.

Nexavar gained expanded US approval for the treatment of late-stage differentiated thyroid cancer under the FDA’s priority reviewprogramme. The drug was previously approved for the treatment of advanced kidney cancer and for advanced liver cancer.

Onyx was acquired by Amgen earlier this year for $10.4 billion, granting the latter rights to Nexavar.

Roche’s Kadcyla approved in the EU for advanced HER2-positive breast cancer

Roche announced that Kadcyla (trastuzumab emtansine or T-DM1), the latest targeted medicine from its HER2 franchise and its first antibody-drug conjugate, has been approved by the European Commission for people with previously treated HER2-positive advanced breast cancer.

Specifically, Kadcyla is indicated as a single agent for the treatment of adults with HER2-positive, unresectable locally advanced or metastatic breast cancer who previously received Herceptin (trastuzumab) and a taxane, separately or in combination. The indication also stipulates that those treated should either have received prior therapy for locally advanced or metastatic disease, or have had disease recurrence during or within six months of completing adjuvant therapy.

“Kadcyla’s approval in the EU is important because this type of targeted medicine has been shown in clinical studies to offer clear benefits for people with advanced HER2-positive breast cancer,” said Hal Barron, M.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Now that Kadcyla has been approved, we can begin discussions with the relevant EU reimbursement authorities to ensure that people who need this medicine can receive it as quickly as possible. »

The decision is based on results from the pivotal Phase III EMILIA study in which people previously treated with Herceptin and a taxane for their HER2-positive advanced breast cancer were randomised to receive either Kadcyla or a standard treatment, lapatinib and Xeloda (capecitabine). People receiving Kadcyla survived significantly longer than those who received lapatanib and Xeloda (30.9 vs 25.1 months) and also lived for nearly 10 months (9.6 months) without their disease getting worse, a median of 3.2 months longer than those who received lapatinib and Xeloda. They also experienced fewer of the severe side effects commonly associated with chemotherapy, as Kadcyla’s targeted mode of action works to deliver the treatment directly to cancer cells, limiting damage to healthy tissues.

 

Source: Roche

Roche Cancer Vaccine Pact Could Net Immatics $1B

Roche will oversee clinical development and commercialization of all immunotherapies generated by immatics biotechnologies under a cancer vaccine and immunotherapy collaboration that could net the German clinical-stage biopharma more than $1 billion.

Roche agreed to pay immatics $17 million up-front and additional unspecified committed research funding, plus more than $1 billion in milestone payments and royalties across three cancer indications, to be based on sales of the cancer vaccines and immunotherapies resulting from the companies’ collaboration.

The collaboration will focus on research, clinical development, and commercialization of a number of new tumor-associated peptide (TUMAP)-based cancer vaccine candidates and other immunotherapies in oncology, targeting primarily gastric, prostate, and non-small cell lung cancer. Furthest along in development among the candidates is IMA942, for gastric cancer, which according to the companies is ready for Phase I trials.

Also as part of the collaboration, immatics will use its XPRESIDENT® technology platform to identify TUMAP candidates for development of cancer vaccines and other compounds targeting cancer peptide antigens, primarily in gastric, prostate, and non-small cell lung cancer. According to the companies, XPRESIDENT is the only known high-throughput research technology capable of directly identifying, quantifying, and prioritizing cancer antigens recognized by T lymphocytes based on the ability of the immune system to detect them.

“The wealth of relevant cancer-specific antigens that we expect to emerge from this research collaboration will provide an extraordinary opportunity to elicit broad tumor-specific immune responses upon vaccination, especially when combined with other immunomodulatory molecules in our pipeline,” Hy Levitsky, Roche’s head of cancer immunology experimental medicine, said in a statement. “Discovery of novel antigens also will provide unique targets for other protein-based anti-cancer agents currently under development.”

immatics’ collaboration with Roche comes about a month after the company won €34 million ($46 million) in Series D financing—of which €12 million ($16 million) will be received immediately—to conclude development of its lead vaccine IMA901, now in a Phase III trial, including completing all activities needed to prepare for regulatory filings in the United States and Europe.

IMA901 is a cancer vaccine consisting of 10 TUMAPs found to be highly overexpressed in the majority of patients suffering from renal cell carcinoma (RCC). The vaccine has U.S. and European orphan drug designations for treating RCC in HLA-A*02 positive patients. The Phase III trial is designed to evaluate overall survival with IMA901 in combination with Pfizer ‘s Sutent® (sunitinib), the current standard first-line therapy, compared with sunitinib alone in patients with metastatic and/or locally advanced RCC. A total of 339 patients are enrolled in the trial, which is expected to generate interim overall survival results in 2014, with final data in 2015.

Source : genengnews

NICE requests more data on bortezomib for multiple myeloma

NICE requests more data on bortezomib for multiple myeloma

In draft guidance, published today (12 November), NICE has asked Janssen to provide more data on the effectiveness of their product, bortezomib (Velcade) as a treatment for some patients with newly diagnosed multiple myeloma.
This appraisal is examining the use of bortezomib for treating multiple myeloma in combination with dexamethasone and thalidomide. The draft guidance has been issued for consultation and the manufacturer now has an opportunity to respond to the independent Appraisal Committee’s considerations and requests.
NICE has requested further evidence on the clinical and cost effectiveness of bortezomib in combination with dexamethasone compared with current standard treatment of newly diagnosed patients who are suitable for high dose chemotherapy with haematopoietic stem cell transplantation. Standard treatment in the UK is a combination of cyclophosphamide, thalidomide and dexamethasone.
The draft guidance does not currently recommend bortezomib in combination with thalidomide and dexamethasone.
Dr Carole Longson, Health Technology Evaluation Centre Director at NICE said: « The independent Appraisal Committee could not assess whether bortezomib in combination with dexamethasone is a cost-effective treatment option because it did not have sufficient information to do so. The next step in the NICE process is for the manufacturer to consider the Committee’s comments and respond to its request for further evidence. »
Consultees, including the manufacturer, healthcare professionals and members of the public are now able to comment on the preliminary recommendations which are available for public consultation. Comments received during this consultation will be fully considered by the Committee and following this meeting the next draft guidance will be issued.
Until final guidance is issued, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its final guidance on a technology, it replaces local recommendations across the country.
1. The draft guidance will be available from 12 November 2013. Embargoed copies of the draft guidance are available from the NICE press office on request.
2. The cost of bortezomib is £762.38 per 3.5 mg vial. The average cost of a course of treatment with bortezomib given with dexamethasone is estimated to be £12,260.91 and the average cost of a course of treatment with bortezomib given with dexamethasone and thalidomide is estimated to be £24,840.10.
3. The Committee agreed that treatment with bortezomib and dexamethasone was associated with statistically significant improvements in post-induction overall response rates compared with vincristine, adriamycin and dexamethasone, whereas induction treatment with bortezomib, thalidomide and dexamethasone resulted in statistically significant improvements in overall response rates (post-induction and post-stem cell transplantation) and progression-free survival compared with thalidomide and dexamethasone. However, it concluded that no direct evidence was available to compare the efficacy of bortezomib, thalidomide and dexamethasone or bortezomib and dexamethasone with cyclophosphamide, thalidomide and dexamethasone, the comparator regimen considered to be current standard of care in the UK.
4. The most plausible cost per quality-adjusted life year (QALY) for bortezomib, thalidomide and dexamethasone compared with cyclophosphamide, thalidomide and dexamethasone was likely to be substantially higher than the £39,000 per QALY compared with thalidomide and dexamethasone.
5. NICE already recommends bortezomib as an option for the treatment of progressive multiple myeloma in people who are at first relapse having received one prior therapy and who have undergone, or are unsuitable for, bone marrow transplantation. NICE Technology Appraisal 129
6. Thalidomide in combination with an alkylating agent and a corticosteroid is recommended as an option for the first-line treatment of multiple myeloma in people for whom high-dose chemotherapy with stem cell transplantation is considered inappropriate. Bortezomib (Velcade, Janssen) is also recommended under these circumstances, if the person is unable to tolerate or has contraindications to thalidomide. NICE Technology Appraisal 228
7. Lenalidomide in combination with dexamethasone is recommended as a treatment option for people with multiple myeloma who have received two or more prior therapies.
About NICE
The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in the health and social care system. We develop guidance, standards and information on high-quality health and social care. We also advise on ways to promote healthy living and prevent ill health.
Formerly the National Institute for Health and Clinical Excellence, our name changed on 1 April 2013 to reflect our new and additional responsibility to develop guidance and set quality standards for social care, as outlined in the Health and Social Care Act (2012).
Our aim is to help practitioners deliver the best possible care and give people the most effective treatments, which are based on the most up-to-date evidence and provide value for money, in order to reduce inequalities and variation.
Our products and resources are produced for the NHS, local authorities, care providers, charities, and anyone who has a responsibility for commissioning or providing healthcare, public health or social care services.
To find out more about what we do, visit our website: http://www.nice.org.uk and follow us on Twitter: @NICEComms.

 

FDA approves Roche’s Gazyva (obinutuzumab) for people with previously untreated chronic lymphocytic leukemia (CLL)

Gazyva demonstrated an 84 percent reduction in the risk of disease worsening or death when combined with chemotherapy compared to chemotherapy alone
Gazyva is the first medicine approved with the FDA’s Breakthrough Therapy Designation
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) approved Gazyva (obinutuzumab), also known as GA101, in combination with chlorambucil chemotherapy for the treatment of people with previously untreated chronic lymphocytic leukemia (CLL). Gazyva is the first medicine approved with the FDA’s Breakthrough Therapy Designation and the fifth cancer medicine from Roche approved by the FDA in the past three years.
“Gazyva is an important new medicine for people with newly diagnosed chronic lymphocytic leukemia as based on clinical data, it more than doubled the time people lived without their disease worsening compared to chlorambucil alone,” said Hal Barron, M.D., chief medical officer and head of Global Product Development. “We have spent 20 years researching blood cancer medicines, and we will continue to study Gazyva to assess its efficacy in other types of blood cancers.”
The FDA granted Gazyva Breakthrough Therapy Designation due to the significance of the positive progression-free survival (PFS) results from the Phase III CLL11 trial and the serious and life-threatening nature of CLL.
Today’s FDA approval is based on the outcomes of the CLL11 trial. The trial showed that people who received Gazyva in combination with chlorambucil chemotherapy had significantly reduced risk of disease progression or death (HR=0.16; p<0.0001) and lived significantly longer without their disease getting worse compared to those who received chlorambucil alone (median PFS 23.0 months vs. 11.1 months). The most common Grade 3/4 adverse events for those who received Gazyva in combination with chlorambucil compared to chlorambucil alone were infusion-related reactions during the first infusion (21 percent vs. 0 percent [chlorambucil is an oral medicine]), low platelet count (thrombocytopenia, 11 percent vs. 3 percent) and low count of certain types of white blood cells (neutropenia, 34 percent vs. 16 percent), though this did not result in an increased rate of infections in the Gazyva arm.
Final data from the CLL11 trial investigating the direct comparison between Gazyva in combination with chlorambucil and MabThera/Rituxan (rituximab) in combination with chlorambucil (Stage 2), will be presented at the American Society of Hematology’s (ASH) 55th Annual Meeting in December 2013
Marketing applications have also been submitted to other regulatory authorities, including the European Medicines Agency (EMA).

About Chronic Lymphocytic Leukemia (CLL)
CLL is one of the most common forms of blood cancer and in 2013, it is expected that there will be nearly 5,000 deaths from CLL in the United States. Most cases of CLL (95 percent) start in white blood cells called B-cells that have a protein called CD20 on their surface.

About Gazyva
Gazyva is a new monoclonal antibody designed to attach to CD20, a protein found only on B-cells. It attacks targeted cells both directly and together with the body’s immune system.
Gazyva was discovered by Roche Glycart AG, a wholly owned, independent research unit of Roche. In the United States, Gazyva is part of a collaboration between Genentech and Biogen Idec.

Gazyva is now approved in combination with chlorambucil for people with previously untreated chronic lymphocytic leukemia (CLL) and is additionally being investigated in a large clinical programme, including multiple head-to-head Phase III studies compared to MabThera/Rituxan in indolent non-Hodgkin lymphoma (NHL) and diffuse large B-cell lymphoma (DLBCL).

Gazyva Efficacy in CLL
The pivotal Phase III CLL11 trial, conducted in cooperation with the German CLL Study Group (GCLLSG), is a multicentre, open-label, randomised three-arm study investigating the efficacy and safety profile of either Gazyva plus chlorambucil or MabThera/Rituxan plus chlorambucil compared to chlorambucil alone in 781 previously untreated people with CLL and co-existing medical conditions.
The study showed that Gazyva demonstrated a statistically significant 84 percent reduction in the risk of disease worsening or death (PFS; HR=0.16, 95 percent CI 0.11-0.24, p<0.0001) when combined with chlorambucil compared to chlorambucil alone in people with previously untreated CLL and co-existing medical conditions. In the CLL11 study, no new safety signals were detected for Gazyva.
Gazyva in combination with chlorambucil more than doubled the time people with newly diagnosed CLL lived without their disease getting worse (median PFS: 23.0 vs. 11.1 months).
75.9 percent of people responded to Gazyva in combination with chlorambucil (overall response rate, or ORR) compared to 32.1 percent with chlorambucil alone.
More than a quarter of the people who received Gazyva in combination with chlorambucil achieved a complete response (CR: 27.8 percent vs. 0.9 percent).

About Roche in hematology

For more than 20 years, Roche has been developing medicines that redefine treatment in hematology. Today, we’re investing more than ever in our effort to bring innovative treatment options to people with cancers of the blood.
In addition to Gazyva, Roche’s pipeline of potential hematology medicines includes two antibody-drug conjugates (anti-CD79b [RG7596] and anti-CD22 [RG7593]), a small molecule antagonist of MDM2 (RG7112) and in collaboration with AbbVie, a small molecule BCL-2 inhibitor (RG7601/GDC-0199/ABT-199).

Source: Roche