On September 22, 2017 Novartis reported a new collaboration with The Max Foundation to support continued access to treatment at no cost for nearly 34,000 current patients with chronic myeloid leukemia (CML), gastrointestinal tumors (GIST) and other rare cancers (Press release, Novartis, SEP 22, 2017, View Source [SID1234520597]). The two organizations have been long-time collaborators in providing access to care for patients in lower-income countries through the Glivec International Patient Assistance Program (GIPAP), one of the most innovative patient assistance programs ever implemented on a global scale.

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The new collaboration, called CMLPath to Care(TM), is an evolution from GIPAP, a partnership that provided Glivec (imatinib)* at no cost to diagnosed patients in lower-income countries where there may not be access to reimbursement or funding mechanisms, and to those unable to pay for the medication. Under the new initiative, The Max Foundation, a global, patient-focused, non-governmental organization (NGO), will assume from Novartis the responsibility for delivering the treatment to these patients, including supply chain management. Novartis will provide funding and drug donation support. The collaborative agreement runs through Q1 2021 with an option to extend. During this timeframe, Novartis expects to donate more than $29 million to the collaboration, along with approximately 315,000,000 doses of medicine.

Novartis introduced GIPAP in 2002 after recognizing the impact of its breakthrough cancer therapy, Glivec. The program has served the CML treatment needs of approximately 75,000 people since its inception.

"Fifteen years ago, Novartis recognized the critical importance of ensuring patients in lower-income countries had access to breakthrough cancer therapy, and we partnered with The Max Foundation to develop a revolutionary global program to address this need," said Bruno Strigini, CEO of Novartis Oncology. "CMLPath to Care renews and extends our unique collaboration with The Max Foundation and builds on the strengths of both organizations to better serve these patients."

CMLPath to Care: A Patient-Centered Model of Access and Support
The goal of CMLPath to Care is to help people living with CML by connecting them and their carers with effective treatments, professional medical capabilities, trained physicians and hands-on support. Under the previous GIPAP model, Novartis managed the entire supply chain for the medicine and interacted directly with local stakeholders (e.g., physicians, treatment centers, NGOs, private companies and governments) in more than 75 countries where it operated. The Max Foundation provided CML patients with psychosocial support and education, services that did not previously exist in certain countries. Over time, changes in local infrastructures and capabilities, new and innovative treatments, and the growth and impact of patient groups prompted Novartis and The Max Foundation to recognize that a new, more flexible approach to access was needed.

With CMLPath to Care, Novartis will provide access to Glivec in nearly 70 countries, and in a subset of countries second-line Tasigna (nilotinib) therapy will be available for approved indications. The Max Foundation will manage the entire medicine supply chain and interactions with local stakeholders under the umbrella of Max Access Solutions, while continuing to provide hands-on, local patient support.

"Since our founding 20 years ago, The Max Foundation has grown extensively in its efforts and ability to help people face cancer with dignity and hope," said Pat Garcia-Gonzalez, CEO of The Max Foundation. "We are proud of the thousands of patients’ lives touched by our long-standing collaboration with Novartis and are pleased with our shared continued innovation, commitment and support for underserved patients with CML and other rare cancers in low resource countries."

Novartis and The Max Foundation Innovate with a Global Direct-to Patient Humanitarian Program: Reimagining What’s Possible for CML Care
CMLPath to Care is one of the broadest cancer treatment access initiatives led by a patient-centered NGO. During the last 15 years, the Novartis-Max Foundation partnership created and maintained a standard of care in many lower-income countries that may not have otherwise been possible for people with CML. In this new model – as in GIPAP – the medicine is provided at no cost for individual patients. This contrasts with more traditional humanitarian programs that provide bulk donations of a medicine. The Max Foundation is unique among NGOs in its ability to manage the complex administration of individual patient care. The transition to CMLPath to Care includes The Max Foundation’s assumption of program administration, supply chain management and oversight of the nearly 34,000 patients, 1,400 physicians, and 450 treatment centers in nearly 70 countries on four continents.

The enduring partnership with The Max Foundation has been a key component of Novartis’ long-term focus on bringing CML care to those who need the most support. The company is dedicated to transforming the lives of people with CML and holds an unwavering commitment to reimagining what is possible for CML treatment through scientific innovation and creative solutions that provide access to care regardless of geography or financial situation.

To ensure a seamless transition for patients, the program will move from Novartis to The Max Foundation through the first half of 2018 on a country-by-country basis. Both organizations are represented on an operational committee that will meet four times each year to ensure the collaboration is meeting its goals and operating efficiently.

On September 22, 2017 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the European Commission has approved Gazyvaro (obinutuzumab) in combination with chemotherapy, followed by Gazyvaro maintenance in people achieving a response, as a new treatment for previously untreated advanced follicular lymphoma (Press release, Hoffmann-La Roche, SEP 22, 2017, View Source [SID1234520594]).
The approval is based on results from the GALLIUM study, the first phase III study in previously untreated follicular lymphoma to show superior progression-free survival (PFS) over MabThera (rituximab)-based treatment, the current standard of care.

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"Every year an estimated 19,000 people in Europe are diagnosed with follicular lymphoma, which is considered to be incurable. We are pleased that with today’s approval of Gazyvaro, these patients now have an improved initial treatment option available to them," said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development. "By challenging our own MabThera medicine head-to-head, we have been able to set a new standard of care for people with follicular lymphoma."

Results from the phase III GALLIUM study showed that Gazyvaro-based treatment reduced the risk of disease progression or death (progression-free survival; PFS), as evaluated by investigator assessment, by 34 percent (HR=0.66; 95% CI 0.51-0.85, p=0.001). As supported by an independent review committee (IRC), the risk of disease progression or death was reduced by 29 percent (HR=0.71; 95% CI 0.54-0.93, p=0.014) compared to MabThera-based treatment. Median PFS has not yet been reached in either treatment arm.
Investigator assessment showed that at three years, 80 percent of patients who received Gazyvaro-based treatment were progression-free compared to 73 percent of patients who received MabThera-based treatment.

This is also supported by the IRC analysis, which found that 81.9 percent of patients who received Gazyvaro-based treatment were progression-free compared to 77.9 percent of patients who received MabThera-based treatment. Adverse events observed with either Gazyvaro or MabThera were consistent with those seen in previous clinical trials when each was combined with various chemotherapies.

This is the third approval for Gazyvaro in the EU. It was approved in 2014, in combination with chlorambucil, for people with previously untreated chronic lymphocytic leukaemia with comorbidities that make them unsuitable for full-dose fludarabine-based therapy. In June 2016 Gazyvaro was also approved in combination with bendamustine, followed by Gazyvaro maintenance, in people with follicular lymphoma who did not respond or who progressed during or up to six months after treatment with MabThera or a MabThera-containing regimen.

About the GALLIUM study

GALLIUM (NCT01332968) is a global phase III open-label, multi-centre, randomised two-arm study examining the efficacy and safety of Gazyvaro plus chemotherapy followed by Gazyvaro alone for up to two years, as compared head-to-head against MabThera plus chemotherapy followed by MabThera alone for two years or until disease progression (whichever occurs first). Chemotherapies (CHOP, CVP or bendamustine) were selected by each participating study site prior to beginning enrolment. GALLIUM included 1401 patients with previously untreated indolent non-Hodgkin lymphoma (iNHL), of which 1202 patients had follicular lymphoma. The primary endpoint of the study was investigator-assessed PFS in patients with follicular lymphoma, with secondary endpoints including PFS assessed by IRC, PFS in the overall study population (iNHL), response rate (overall response, ORR; and complete response, CR), overall survival (OS), and safety. The GALLIUM study is being conducted in cooperation with the NCRI (United Kingdom), GLSG (Germany), the East German Study Group Hematology and Oncology (OSHO; Germany).

On September 22, 2017 Bristol-Myers Squibb Company (NYSE:BMY) reported that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Opdivo (nivolumab) for the treatment of unresectable advanced or recurrent gastric cancer which has progressed after chemotherapy (Press release, Bristol-Myers Squibb, SEP 22, 2017, View Source [SID1234520593]). This approval was based on the Phase 3 study ATTRACTION-2 (ONO-4538-12), in which Opdivo significantly reduced patients’ risk of death by 37% (HR 0.63 [95% CI: 0.51-0.78, p<0.0001]) when compared to placebo. Furthermore, Opdivo demonstrated a greater overall survival rate at 12 months versus placebo, 26.2% (95% CI: 20.7-32.0) and 10.9% (6.2-17.0), respectively. The safety profile of Opdivo in this study was consistent with previously reported studies in solid tumors, and discontinuation rates due to treatment-related adverse events (TRAEs) in the Opdivo and placebo arms were comparable.

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"The approval of Opdivo for advanced or recurrent gastric cancer in Japan offers healthcare providers and patients a much-needed new treatment option, and reinforces our commitment to advance the treatment of cancer through Immuno-Oncology based approaches," said Murdo Gordon, executive vice president and chief commercial officer, Bristol-Myers Squibb. "Opdivo has now been approved for six indications in Japan, underscoring the success of the Ono Pharmaceutical and Bristol-Myers Squibb partnership and our shared commitment to delivering innovative medicines to patients and advancing cancer care in Japan and around the world."

The prevalence of gastric cancer is highest in Asian countries, and it is the second most common cancer diagnosis in Japan, with nearly 134,000 people diagnosed in 2016. While treatment options are available for patients in earlier lines of therapy, nearly all patients with advanced gastric cancer continue to experience disease progression, reinforcing the need for innovative new treatment options.

"I have seen firsthand how patients and their families are negatively impacted by gastric cancer, which in Japan took approximately 50,000 lives last year," said Taroh Satoh, M.D., Frontier Science for Cancer and Chemotherapy, Graduate School of Medicine, Osaka University, Suita, Japan. "It is encouraging that Japanese patients with advanced or recurrent gastric cancer now have an Immuno-Oncology treatment option with the approval of Opdivo, which has shown in clinical trials to improve survival across all patient types, including those whose tumors express PD-L1."

About ATTRACTION-2 (ONO-4538-12)

The approval is based on the results of ATTRACTION-2 (ONO-4538-12), a Phase 3 randomized, double-blind, placebo-controlled clinical trial conducted in Japan, South Korea and Taiwan, evaluating the efficacy and safety of Opdivo in patients with surgically unresectable previously treated advanced or recurrent gastric cancer, including gastroesophageal junction cancer, refractory to or intolerant of at least two chemotherapy regimens. This study was conducted by Ono Pharmaceutical Co. Ltd. of Japan, and data is currently in press with The Lancet.

The ATTRACTION-2 (ONO-4538-12) study evaluated the efficacy of Opdivo using overall survival as the primary endpoint. The secondary endpoints included objective response rate, duration of response, progression-free survival, best overall response, time to response, disease control rate and safety measures.

In the trial, Opdivo 3 mg/kg or placebo was administered every two weeks until disease progression or discontinuation due to unacceptable toxicity. The safety profile of Opdivo was consistent with previously reported studies in solid tumors. TRAEs of any grade and grade 3/4 occurred in 42.7% versus 26.7% and 10.3% versus 4.3% of Opdivo-treated and placebo-treated patients, respectively. The grade 3/4 TRAEs reported in more than two patients were diarrhea, fatigue, decreased appetite, pyrexia, as well as increased aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in the Opdivo group, and fatigue and decreased appetite in the placebo group. The Opdivo and placebo-treated patients had similar rates of TRAEs leading to discontinuation, 2.7% and 2.5%, respectively.

On September 22, 2017 AbbVie (NYSE: ABBV) and Bristol-Myers Squibb Company (NYSE: BMY) reported that a clinical trial collaboration to evaluate the combination of AbbVie’s investigational antibody drug conjugate ABBV-399 and Bristol-Myers Squibb’s immunotherapy Opdivo (nivolumab) in c-Met overexpressing non-small cell lung cancer (NSCLC) (Press release, Bristol-Myers Squibb, SEP 22, 2017, View Source [SID1234520592]).

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A Phase 1b clinical study is underway that includes evaluating the potential of combining Opdivo, which is designed to alleviate immune suppression, with ABBV-399 to explore the tolerability and potential efficacy of the combination in subjects with advanced c-Met overexpressing NSCLC who failed one prior line of chemotherapy. This study could expand into additional solid tumors in the future.

"Cancer remains one of the most challenging medical conditions for patients and physicians," said Tom Hudson, M.D., vice president, oncology early discovery and development, AbbVie. "Therapeutic advances continue to be achieved every day and we are committed to exploring the potential of our investigational compounds with other approved treatments with the goal to deliver a significant impact to patients."

"We continue to explore the potential of novel combinations of medicines with Opdivo, and AbbVie’s investigational treatments will help evaluate the role of new targets in combination with immunotherapy" said Fouad Namouni, M.D., head of Development, Oncology, Bristol-Myers Squibb. "We look forward to continuing to partner our PD1 with AbbVie’s early- and late-stage assets as a possible treatment option for patients with lung cancer."

AbbVie is the sponsor conducting the trial. Specific terms of the agreement were not disclosed.

About Opdivo

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Opdivo’s leading global development program is based on Bristol-Myers Squibb’s scientific expertise in the field of Immuno-Oncology and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has enrolled more than 25,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 60 countries, including the United States, the European Union, and Japan. In October 2015, the company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.

About ABBV-399

ABBV-399 (telisotuzumab vedotin) is a first-in-class anti-c-Met antibody drug conjugate that targets both c-Met-amplified and c-Met-overexpressing tumors. It is currently being investigated to treat advanced solid tumors. c-Met expression is significantly higher in many solid tumors compared to normal tissue and is a marker of poor prognosis. ABBV-399 is an investigational compound and its safety and efficacy have not been evaluated by the FDA or any other health authority.