On June 5, 2016 Exelixis, Inc. (NASDAQ:EXEL) reported that its collaborator Genentech, a member of the Roche Group, will present preliminary results from a phase 1b clinical trial evaluating the safety and clinical activity of cobimetinib, an Exelixis-discovered MEK inhibitor, in combination with atezolizumab, an anti-PD-L1 antibody discovered and developed by Genentech, in patients with metastatic colorectal cancer (CRC) (Press release, Exelixis, JUN 5, 2016, View Source;p=RssLanding&cat=news&id=2175111 [SID:1234513003]). The results will be the subject of an oral presentation (Abstract #3502) today at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which is being held June 3-7 in Chicago, Illinois. Johanna Bendell, M.D., director of the Gastrointestinal Cancer Research Program at the Sarah Cannon Research Institute/Tennessee Oncology, Nashville, Tennessee, will present the results.

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"These early data on the combination of cobimetinib, an Exelixis-discovered MEK inhibitor, and atezolizumab, an anti-PD-L1 antibody discovered and developed by Genentech, are encouraging and warrant further study in people with previously-treated metastatic colorectal cancer, including those with microsatellite stable disease," said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. "Based on these results, Genentech has initiated the COTEZO phase 3 trial in patients with unresectable locally advanced or metastatic colorectal cancer."

This ongoing phase 1b trial includes both a dose escalation stage and dose expansion stage. The trial’s primary objective is the evaluation of the safety and tolerability of the combination. Secondary endpoints include objective response rate (ORR) per RECIST, duration of response, progression-free survival (PFS), overall survival (OS), as well as evaluation of biomarkers.

As of the February 12, 2016 data cut-off, 23 patients with advanced CRC (22 with mutant KRAS and one with wild-type KRAS) were enrolled during the trial’s escalation and expansion phases. No dose-limiting toxicities were observed. The median follow-up for safety in CRC patients was 3.8 months, with a range of 1.1 to 15.1 months. There were no all-cause grade 5 or treatment-related grade 4 AEs reported, and incidence of treatment-related grade 3 AEs was 35% (n=8). The most common treatment-related AEs, regardless of severity, included: diarrhea (70% of patients); fatigue (52%); dermatitis acneiform (44%); rash (35%); and nausea, maculopapular rash and pruritus (each 26%).

The ORR for the combination was 17%, including four confirmed partial responses; additionally five patients achieved stable disease. The median duration of response was not yet reached, with a range of 5.4 to more than 11.1 months.

Median PFS for all CRC patients enrolled in the trial was 2.3 months, with a range of 1.8 to 9.5 months. The six-month PFS was 35%. Median OS for all CRC patients was not evaluable, while six-month OS was 72%.

Recently Initiated COTEZO Phase 3 Pivotal Trial

In June 2016 Genentech initiated COTEZO, a phase 3 pivotal trial of the combination of cobimetinib and atezolizumab in unresectable locally advanced or metastatic colorectal cancer. The trial is expected to enroll 360 patients who have received at least two prior chemotherapies in the metastatic disease setting. The primary endpoint of the COTEZO trial is overall survival. More information about the COTEZO phase 3 pivotal trial is available at www.clinicaltrials.gov.

Additional Cobimetinib Data Presented at ASCO (Free ASCO Whitepaper) 2016

The oral presentation in colorectal cancer is one of eight cobimetinib abstracts being presented at the ASCO (Free ASCO Whitepaper) 2016 Annual Meeting this week. Additional data presentations include studies of cobimetinib in combination with other therapies to treat triple-negative breast cancer and BRAF-mutant melanoma. For full logistical information on these other presentations, please see Exelixis’ ASCO (Free ASCO Whitepaper) announcement press release issued on April 20, 2016, available online here.

About the Cobimetinib Development Collaboration

Exelixis discovered cobimetinib internally and advanced the compound to investigational new drug (IND) status. In late 2006, Exelixis entered into a worldwide collaboration agreement with Genentech, under which Exelixis received initial upfront and milestone payments for signing the agreement and submitting the IND. Following the determination of the maximum tolerated dose in phase 1 by Exelixis, Genentech exercised its option to further develop cobimetinib.

Under the terms of the collaboration, Exelixis is entitled to an initial equal share of U.S. profits and losses resulting from sales of cobimetinib to treat any form of cancer, which will decrease as sales increase, and will share in U.S. marketing and commercialization costs. In November 2013, Exelixis exercised its option to co-promote cobimetinib in the United States and, under the terms of the agreement, the company is fielding 25 percent of the U.S. sales force for the product’s first commercial indication in specific forms of BRAF mutation-positive advanced melanoma, closely coordinating its efforts with Genentech. Outside of the United States, Exelixis is eligible to receive royalties on any sales.

Cobimetinib in combination with vemurafenib is now approved in multiple countries, including the United States, European Union, Switzerland, Canada, Australia and Brazil, to treat specific forms of BRAF mutation-positive advanced melanoma. Further country approvals are anticipated in 2016 and beyond. Cobimetinib is also the subject of a clinical development program aimed at evaluating its potential in combination with a variety of investigational and approved therapies in disease settings including metastatic melanoma, triple-negative breast cancer and advanced solid tumors.

COTELLIC Indication

COTELLIC (cobimetinib) is a prescription medicine that is used with ZELBORAF (vemurafenib), to treat a type of skin cancer called melanoma that has spread to other parts of the body or cannot be removed by surgery, and that has a certain type of abnormal "BRAF" gene.

A patient’s healthcare provider will perform a test for the BRAF gene to make sure that COTELLIC is right for them. It is not known if COTELLIC is safe and effective in children under 18 years of age.

COTELLIC Important Safety Information

Patients should avoid sunlight during treatment with COTELLIC. COTELLIC can make their skin sensitive to sunlight. They may burn more easily and get severe sunburns. To help protect against sunburn, they should wear clothes that protect their skin, including their head, face, hands, arms, and legs. They should use lip balm and a broad-spectrum sunscreen with SPF 30 or higher.

COTELLIC may cause serious side effects, including risk of new skin cancers, bleeding problems, heart problems, severe rash, eye problems, liver problems, muscle problems (rhabdomyolysis), and photosensitivity. Patients should tell their doctor if they are pregnant or plan to become pregnant, as COTELLIC and ZELBORAF can harm an unborn baby. Patients who take COTELLIC should use effective methods of birth control during treatment, for 2 weeks after stopping COTELLIC, and for at least 2 months after stopping ZELBORAF. Do not breastfeed during treatment with COTELLIC and for 2 weeks after the final dose. Patients along with their healthcare provider should decide if they will take ZELBORAF or breastfeed. Patients should not do both.

Patients should tell their healthcare provider about all the medicines they take. Some types of medicines will affect the blood levels of COTELLIC.

Common side effects of COTELLIC include diarrhea, sunburn or sun sensitivity, nausea, fever, and vomiting. COTELLIC can also cause changes in blood test results.

Patients should tell their healthcare provider if they have any side effect that bothers them or that does not go away. These are not all the possible side effects of COTELLIC. For more information about side effects, patients should ask their healthcare provider or pharmacist.

Patients should call their doctor for medical advice about side effects. They may report side effects to FDA at (800) FDA-1088 or www.fda.gov/medwatch. They may also report side effects to Genentech at (888) 835-2555.

Please see full COTELLIC Prescribing Information and Patient Information for additional Important Safety Information.

On June 5, 2016 Xcovery, a developer of targeted therapeutics for cancer, reported that results from an expansion cohort in the ongoing Phase I/II clinical study of its investigational tyrosine kinase inhibitor (TKI), ensartinib (X-396), in patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2016 held in Chicago, Illinois (Press release, Xcovery, JUN 5, 2016, View Source [SID:1234513092]).

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Results from this multicenter expansion study demonstrated that ensartinib is well-tolerated and induces response in both crizotinib-naive and crizotinib-resistant ALK-positive NSCLC patients, as well as patients with CNS disease. The results also showed that plasma NGS with the Resolution ctDxTM blood-based platform may be used to detect ALK kinase domain mutations to select patients for therapy and monitor changes in response to treatment in a non-invasive manner. Results were presented by Dr. Leora Horn, MD, MSc, Vanderbilt University Medical Center, in a poster titled "Plasma genotyping of patients in the eXalt2 trial: ensartinib+ (X-396) in ALK-positive non-small cell lung cancer (NSCLC)."

"Ensartinib has shown promising activity in ALK-positive NSCLC patients with durable responses observed in patients who are crizotinib-naïve and patients with resistance to crizotinib and second generation ALK tyrosine kinase inhibitors," said Dr. Horn. "The plasma sequencing of patients in the expansion study have identified a potential way to identify and select patients for therapy and to monitor for response and the development of acquired resistance."

About the Expansion Cohort of the Phase I/II "eXalt2" Study

In this multicenter study, 38 patients with ALK-positive (via FISH or IHC) advanced or recurrent NSCLC were treated with at least 200mg of ensartinib on 28-day cycles with plasma samples collected on the first day of each cycle. Major inclusion criteria for the expansion cohort included: ALK-positive (via FISH or IHC) advanced or recurrent NSCLC, measurable disease and ECOG performance status (PS) 0-1. Asymptomatic treated or untreated brain metastases (CNS) and leptomeningeal disease were allowed.

Key conclusions from the study include:

Ensartinib has shown promising activity in ALK-positive NSCLC patients with durable responses observed in patients who are crizotinib-naïve and patients with resistance to crizotinib and second generation ALK TKIs.
Plasma NGS can be used to detect ALK kinase domain mutations and monitor changes in response to treatment in a non-invasive manner.
In this study, ALK kinase domain mutations were detected in 4/11 patients who had prior crizotinib and 2/4 patients who had prior crizotinib and ceritinib. G1202R was found in both of the latter cases.
1/2 patients whose plasma detected the G1202R mutation prior to start of the trial responded to ensartinib.
Further study of this methodology is ongoing to correlate the presence of ALK kinase domain mutations with response and resistance to ALK TKI therapy.
A Phase III trial is ongoing comparing ensartinib to crizotinib in TKI naïve ALK-positive NSCLC patients.
About Ensartinib (X-396)

Xcovery’s lead asset is X-396, a small molecule, anaplastic lymphoma kinase (ALK) inhibitor. It is being studied in the Xalt2 Study, a phase II trial for the treatment of ALK-positive non-small cell lung cancer (NSCLC). The Xalt2 Study is currently enrolling patients. To learn more, visit: www.xalt2study.com or ClinicalTrials.gov under trial identifier NCT01625234.

About NSCLC and ALK

Lung cancer is the second most common type of cancer identified in the United States with an estimated 221,000 new diagnoses expected in 2015. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for an estimated 85-90% of the lung cancer cases. The anaplastic lymphoma kinase (ALK) gene is located on chromosome 2 and rearrangement of the ALK gene can lead to its activation or expression, therefore increasing a person’s chance of developing certain types of cancer, including NSCLC. Between three and seven percent of patients with NSCLC have the ALK rearrangement, making this a molecular target warranting investigation for NSCLC patients.

On June 6, 2016 Kyowa Hakko Kirin Co., Ltd. (Tokyo; 4151 President and CEO: Nobuo Hanai; "Kyowa Hakko Kirin") reported the preliminary results today from the pivotal Phase 2 study of mogamulizumab (Code name: KW-0761) for the treatment of Adult T-cell Leukemia-Lymphoma (ATL) (Press release, Kyowa Hakko Kirin, JUN 5, 2016, View Source [SID:1234513141]).

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"We are very pleased to announce that we have completed the largest, prospective randomized clinical trial for relapsed/refractory ATL and that the preliminary results of this pivotal Phase 2 study showed potential of mogamulizumab for the treatment of relapsed/refractory ATL, where no standard of care exists" said Yoichi Sato, Managing Executive Officer, Vice President, Head of Research and Development Division of Kyowa Hakko Kirin.

Study Design
Patients from the USA, EU, and Latin America with aggressive relapsed or refractory ATL were randomized 2:1 to treatment with mogamulizumab or to 1 of 3 investigator choice (IC) regimens (Gem/Ox, DHAP or pralatrexate). Patients in the IC arm were permitted to cross-over to treatment with mogamulizumab after progression. Overall Response Rate (ORR; confirmed and unconfirmed) was assessed by the treating investigator (IA) and through blinded assessment by independent review (IR).

Study Results
71 patients were randomized (47 to mogamulizumab, 24 to IC). In the mogamulizumab treated group, unconfirmed ORR was 28% (13/47) by IR and 34% (16/47) by IA, while in the IC group, unconfirmed ORR was 8% (2/24) by IR and 0/24 by IA. Confirmed ORR (response maintained at successive evaluations approximately 8 weeks apart) for mogamulizumab was 11% by IR and 15% by IA, while there were no confirmed responses in the IC group. 18 out of 24 patients in the IC arm crossed over to mogamulizumab and 3 patients (17%) responded (1 of the responses was confirmed). The median duration of confirmed response for mogamulizumab was 5.0 months by IR and 5.5 months by IA. One patient had a response lasting more than 9 months. The frequently observed treatment-emergent, adverse events in the mogamulizumab arm included infusion reactions (46.8%), rash/drug eruption (19.1%) and infections (51.1%). The safety data collected from this study were similar to what has previously been documented.

These data from the study were presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 5th, 2016.
The Kyowa Hakko Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.

About Mogamulizumab
Mogamulizumab is a humanized mAb directed against CC chemokine receptor 4 (CCR4), which is frequently expressed on leukemic cells of certain hematologic malignancies including ATL. Mogamulizumab was produced using Kyowa Hakko Kirin’s proprietary POTELLIGENT platform, which is associated with enhanced antibody-dependent cellular cytotoxicity (ADCC), and was launched in Japan in May 2012 for the treatment of patients with relapsed or refractory CCR4-positive ATL under the trade name POTELIGEO. The drug was approved for indication expansion and was granted marketing authorization in Japan for the treatment of patients with relapsed or refractory CCR4-positive, peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) in March 2014, and with chemotherapy-naive CCR4-positive ATL in December 2014.

About Adult T-cell Leukemia-Lymphoma (ATL)
ATL is a disease entity within the category of mature T- and NK-cell neoplasms, according to the classification by the World Health Organization. It is an extremely aggressive T lymphocytic malignancy that originates in T-cells infected with the human T-lymphotropic virus-1(HTLV-1). ATL has a very distinct epidemiology and geographic distribution, primarily involving areas of Japan, the Caribbean Basin, parts of South America, the Middle East and sub-Saharan Africa, where HTLV-1 infection is endemic. In non-endemic regions such as North America and Europe, HTLV-1 infection is mainly found in immigrants from endemic areas, their offspring or sexual contacts. Treatment regimens for ATL have not been standardized, especially in the relapsed/refractory setting, representing a large unmet medical need in this patient population.

On June 4, 2016 Array BioPharma (Nasdaq: ARRY) reported updated results from a Phase 2 study of the combination of encorafenib and cetuximab, with or without alpelisib, in patients with advanced BRAF-mutant colorectal cancer (BRAFm CRC) (Press release, Array BioPharma, JUN 4, 2016, View Source;p=RssLanding&cat=news&id=2175100 [SID:1234512988]). BRAFm CRC represents a difficult-to-treat subtype of colorectal cancer that impacts 8 to 15 percent of patients. Data from this study suggest that median overall survival (OS) for these patients may exceed one year which is more than double historical published benchmarks for this population. These data were presented at the 2016 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago (Abstract No. 3544).

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With these encouraging results, Array also announced the initiation of a pivotal Phase 3 BEACON CRC (Binimetinib, Encorafenib And Cetuximab COmbiNed) to treat BRAF-mutant ColoRectal Cancer) global clinical trial, assessing the efficacy of binimetinib, encorafenib and cetuximab in comparison to cetuximab and irinotecan-based therapy.

"The BRAF mutation carries a poor prognosis for patients with advanced colorectal cancer, and is particularly unresponsive after first-line therapy," said Josep Tabernero, M.D., Ph.D., Head of the Medical Oncology Department at the Vall d’Hebron University Hospital and the Director of the Vall d’Hebron Institute of Oncology. "In the Phase 2 trial, both treatment regimens showed substantial improvement in progression-free and overall survival compared to historical published benchmarks. What’s more, median overall survival exceeded one year for these patients, again as compared to the benchmarks, which were four to six months, making a case that patients with this difficult-to-treat cancer may benefit from the combination of encorafenib-based regimens."

In the Phase 2 study, 102 patients with BRAFm CRC who had progressed after one or more prior therapies were randomized to receive the doublet regimen of encorafenib and cetuximab (ENCO 200 mg PO QD and CETUX per label; n=50) or the triplet regimen of encorafenib, cetuximab and alpelisib (ENCO, CETUX and ALP 300 mg PO QD; n=52). The Phase 2 analysis for these treatment regimens demonstrated promising clinical activity in patients:

Median OS was 12.4 and 13.1 months for the doublet and triplet regimens, respectively.
Median progression-free survival (PFS) was 4.2 and 5.4 months for the doublet and triplet regimens, respectively.
Overall response rate (ORR) was 22 percent and 27 percent for the doublet and triplet regimens, respectively.
Grade 3 or 4 adverse events (AEs) occurring in greater than 10 percent of patients included anemia, hyperglycemia and increased lipase.
Historical published median PFS and median OS results after first-line treatment range from 1.8 to 2.5 months and four to six months, respectively, and published overall response rates from various studies in this population range between 6 percent to 8 percent.

"There has been a long-standing need to find treatment options for patients with BRAF-mutant colorectal cancer, and we are encouraged that data from the Phase 2 study show encorafenib-based regimens may have this potential," said Victor Sandor, M.D., Chief Medical Officer, Array BioPharma. "We hope these promising findings will bring us one step closer to addressing this high unmet medical need, and we are pleased to be studying encorafenib-based regimens in our global, pivotal Phase 3 BEACON CRC trial in patients with this disease."

About BRAF-Mutant Colorectal Cancer
Colorectal cancer is the third most common cancer among men and women in the United States, with more than 134,000 new cases and nearly 50,000 deaths from the disease projected in 2016. In the United States, BRAF mutations occur in 8 to 15 percent of patients with colorectal cancer and represent a poor prognosis for these patients.

About RAF and encorafenib
RAF is a protein kinase in the MAPK signaling pathway (RAS-RAF-MEK-ERK) that regulates several key cellular activities including proliferation, migration, survival and angiogenesis. Inappropriate activation of this pathway has been shown to occur in many cancers, such as melanoma, colorectal, lung and thyroid cancers. Encorafenib is a late-stage small molecule BRAF inhibitor, which targets key enzymes in this pathway. It is currently being studied in Phase 3 trials in advanced cancer patients, including the COLUMBUS trial studying encorafenib in combination with binimetinib in patients with BRAF-mutant melanoma and the recently initiated BEACON trial that will study encorafenib in combination with binimetinib and cetuximab in patients with BRAF V600E-mutant colorectal cancer. Array projects COLUMBUS top-line results availability during the third quarter of 2016.

– See more at: View Source;p=RssLanding&cat=news&id=2175100#sthash.wUh9JR8S.dpuf

On June 4, 2016 Juno Therapeutics, Inc. (NASDAQ: JUNO), a biopharmaceutical company focused on re-engaging the body’s immune system to revolutionize the treatment of cancer, reported that its investigational chimeric antigen receptor (CAR) T cell product candidates are demonstrating encouraging clinical outcomes for adults and children with B-cell malignancies (Press release, Juno, JUN 4, 2016, View Source;p=RssLanding&cat=news&id=2175102 [SID:1234513025]). Data will be presented at the 52nd Annual Meeting of the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago, including an oral presentation today on JCAR014 (Abstract #102, Hall D1, 8:48 a.m. CT) and a poster presentation tomorrow on JCAR017 (Abstract #3048, Hall A, Board #370, 8:00 a.m. CT).
"We are encouraged by the continued efficacy and duration of response that we are seeing with our defined cell products in patients with B cell malignancies. We are moving rapidly to start potential registration trials for JCAR017 across a range of B cell malignancies, including ALL, NHL, and CLL," said Mark J. Gilbert, M.D., Juno’s Chief Medical Officer. "As our understanding of JCAR017 and JCAR014 evolves, we are increasingly able to study these defined cell product candidates in the outpatient setting, which may allow for greater access to our technologies over time."
JCAR014
Updated results from a randomized Phase I/II study examining JCAR014 in patients with relapsed or refractory (r/r) acute lymphoblastic leukemia (ALL), non-Hodgkin lymphoma (NHL), and chronic lymphocytic leukemia (CLL) will be presented today by Cameron Turtle, MBBS, Ph.D., of the Fred Hutchinson Cancer Research Center. Key data include:
In efficacy-evaluable ALL patients (N=34), complete remission was reported in 34/34 (100%) patients and complete molecular remission as measured by flow cytometry (CmR) was achieved in 32/34 (94%) patients. Additionally, 13/20 (65%) had a complete molecular remission as measured by the highly sensitive technique of IGH deep sequencing. In the cohort that received fludarabine/cyclophosphamide (Flu/Cy) lymphodepletion, 22/22 (100%) patients achieved a complete remission, all of which were a CmR. Median disease free survival (DFS) and overall survival (OS) have not yet been reached with patients followed for up to 18 months. Severe cytokine release syndrome (sCRS) was observed in 14/36 (39%) patients and Grade 3 or higher neurotoxicity was observed in 14/36 (39%) patients.
In patients with multiple NHL histologies (N=20), predominantly diffuse large B-cell lymphoma, who received Flu/Cy lymphodepletion followed by JCAR014 dose level 2 (2×106/kg), 16/20 (80%) had an overall response (OR), of which 10/20 (50%) experienced a complete response (CR). CRs continue in 70% of patients, ranging from 3 to 11+ months. sCRS was observed in 2/20 (10%) patients and Grade 3 or higher neurotoxicity was observed in 2/20 (10%) patients. Notably, 16/20 (80%) patients treated with Flu/Cy lymphodepletion followed by JCAR014 dose level 2 were treated in the outpatient setting, and 6/20 (30%) did not require hospitalization during the first 30 days of treatment.
A total of 13 high-risk CLL patients (complex karyotype, del17p, ibrutinib-refractory, ibrutinib-intolerant) received JCAR014 and either non-Flu/Cy (n=2) or Flu/Cy (n=11) lymphodepleting chemotherapy. In the Flu/Cy patients, OR rate was 10/11 (91%) patients, of which 5/11 (45%) patients achieved CR. CRs are ongoing in 100% of these patients with a range of 3 to 19+ months. sCRS was observed in 3/13 (23%) patients and Grade 3 or higher neurotoxicity was observed in 3/13 (23%) patients.
JCAR017
In addition to the adult JCAR014 data presented today, Rebecca Gardner, M.D., of Seattle Children’s, announced results from Seattle Children’s Phase I study of JCAR017 in pediatric and young adults with CD19+ r/r ALL (n=42) demonstrating 39/42 (93%) patients experienced a complete remission, all of which were a CmR by flow cytometry. In patients who received the Flu/Cy preconditioning regimen, 14/14 (100%) achieved a complete remission and a CmR. sCRS was observed in 10/42 (24%) patients and Grade 3 or higher neurotoxicity was observed in 10/42 (24%) patients.
About Juno’s Chimeric Antigen Receptor (CAR) and T Cell Receptor (TCR) Technologies
Juno’s CAR and TCR technologies genetically engineer T cells to recognize and kill cancer cells. Juno’s CAR T cell technology inserts a gene for a particular CAR into the T cell, enabling it to recognize cancer cells based on the expression of a specific protein located on the cell surface. Juno’s TCR technology provides the T cells with a specific T cell receptor to recognize protein fragments derived from either the surface or inside the cell. When either type of engineered T cell engages the target protein on the cancer cell, it initiates a cell-killing response against the cancer cell. JCAR014 and JCAR017 are investigational product candidates and their safety and efficacy have not been established.

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