On October 3, 2016 Roche reported that new results from studies with its approved or investigational medicines across more than 20 cancer types will be presented during the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress from 7 – 11 October 2016 in Copenhagen, Denmark (Press release, Hoffmann-La Roche , OCT 3, 2016, View Source [SID:SID1234515529]). These include the first pivotal phase III results for Tecentriq, outcomes from early studies of cancer immunotherapy-based combinations, results from clinical studies with a broad range of Roche’s investigational medicines, and new insights from studies that continue to shape a better understanding of how different types of cancer develop and affect people around the world. Schedule your 30 min Free 1stOncology Demo! "At Roche, our focus on understanding human immunology and cancer biology is helping us to develop new medicines that improve outcomes for people with cancer," said Sandra Horning, M.D., Roche’s Chief Medical Officer and Head of Global Product Development. "We look forward to the presentation of the pivotal OAK data for Tecentriq during ESMO (Free ESMO Whitepaper)’s Presidential Symposium, as well as other presentations such as new data from our collaboration with Foundation Medicine that showcase how we are expanding our understanding of each individual’s cancer."
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
At ESMO (Free ESMO Whitepaper), positive results from the Tecentriq phase III lung cancer study known as OAK will be presented as a "late-breaking" abstract in the ESMO (Free ESMO Whitepaper) Presidential Symposium 2 on Sunday, 9 October. Roche recently announced that the study met its co-primary endpoints and showed a statistically significant and clinically meaningful improvement in overall survival (OS) compared with docetaxel chemotherapy in people with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease progressed on or after treatment with platinum-based chemotherapy. In the United States, Roche’s Biologics License Application (BLA) for Tecentriq in NSCLC was granted Priority Review with an action date of 19 October 2016.
In addition to OAK, 19 Roche cancer immunotherapy abstracts featuring Tecentriq and other innovative molecules will be presented. This includes early data assessing Tecentriq in an investigational combination with the approved, targeted Roche medicines Zelboraf (vemurafenib) and Cotellic (cobimetinib) in melanoma, and as a novel investigational combination with Cotellic in colorectal cancer.
Overview of key presentations at ESMO (Free ESMO Whitepaper) 2016
Investigational medicine Abstract title Abstract number
Alecensa
(alectinib)
Updated efficacy and safety from the global phase II NP28673 study of alectinib in patients (pts) with previously treated ALK+ non-small-cell lung cancer (NSCLC)
1263P
Ipatasertib (RG7440) PTEN loss as a predictive biomarker for the Akt inhibitor ipatasertib combined with abiraterone acetate in patients with metastatic castration-resistant prostate cancer (mCRPC) 718O
Tecentriq (atezolizumab)
Primary analysis from OAK, a randomized phase III study comparing atezolizumab with docetaxel in 2L/3L NSCLC LBA44
Atezolizumab (atezo) in platinum (plat)-treated locally advanced/metastatic urothelial carcinoma (mUC): Updated OS, safety and biomarkers from the Ph II IMvigor210 study
783P
IMvigor210: updated analyses of first-line (1L) atezolizumab (atezo) in cisplatin (cis)-ineligible locally advanced/metastatic urothelial carcinoma (mUC)
782PD
Safety, clinical activity and biomarkers of atezolizumab (atezo) in advanced ovarian cancer (OC)
871P
Efficacy and safety of cobimetinib (cobi) and atezolizumab (atezo) in an expanded phase 1b study of microsatellite-stable (MSS) metastatic colorectal cancer (mCRC)
470P
Preliminary safety and clinical activity of atezolizumab combined with cobimetinib and vemurafenib in BRAF V600-mutant metastatic melanoma
1109PD
Clinical activity, safety and predictive biomarker results from a phase Ia atezolizumab (atezo) trial in extensive-stage small cell lung cancer (ES-SCLC)
1425PD
Safety, clinical activity and biomarkers of atezolizumab (atezo) in advanced ovarian cancer (OC)
871P
The SP142 PD-L1 IHC assay for atezolizumab (atezo) reflects pre-existing immune status in NSCLC and correlates with PD-L1 mRNA
1171P
Tumor mutation load assessed by FoundationOne (FM1) is associated with improved efficacy of atezolizumab (atezo) in patients with advanced NSCLC 77P
Real-World Data Second-line metastatic urothelial carcinoma treatment and survival in real-world patients in the US 801P
Author: [email protected]
Boehringer Ingelheim returns development and commercial rights of olmutinib to Hanmi Pharmaceutical
On September 30, 2016 Boehringer Ingelheim reported that development and global commercialization rights of olmutinib, a third-generation EGFR targeted therapy, will be returned to Hanmi Pharmaceutical Co. Ltd (Press release, Boehringer Ingelheim, SEP 30, 2016, http://us.boehringer-ingelheim.com/news_events/press_releases/press_release_archive/2016/9-30-2016-boehringer-ingelheim-returns-development-commercial-rights-olmutinib-hanmi-pharmaceutical.html [SID:SID1234515686]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The decision is based on a re-evaluation of all available clinical data on olmutinib and recent treatment advances made in the treatment of EGFR mutation-positive lung cancer. Boehringer Ingelheim will not initiate new clinical trials for this compound and will work closely with Hanmi Pharmaceutical to ensure a seamless transition of the responsibilities of the current olmutinib clinical development program back to Hanmi Pharmaceutical.
Dr. Jörg Barth, Corporate Senior Vice President, Therapeutic Area Head Oncology, Boehringer Ingelheim said, "We would like to thank Hanmi Pharmaceutical for their collaboration and commitment during our joint development of olmutinib. Partnering is a key pillar of our oncology strategy at all stages of research and development, in order to offer cancer treatments that fit the needs of patients, caregivers and healthcare professionals. Boehringer Ingelheim’s oncology pipeline is robust and transformative, with several compounds currently in clinical development and we strive for best-in-class, breakthrough cancer medications."
Boehringer Ingelheim has successfully launched two products for the treatment of non-small cell lung cancer (NSCLC), which have been widely adopted and established as important additions to current clinical practice. The company continues to increase its investment in research and development and a third of Boehringer Ingelheim’s human pharmaceutical pipeline, that is planned to enter phase I clinical trials in the next 12 months, is in oncology.
Boehringer Ingelheim’s oncology pipeline is built on in-house scientific innovation as well as strong academic and industry collaborations. Two recent examples include a partnership with ViraTherapeutics to develop novel cancer treatments based on oncolytic viruses, with an option to acquire the company at a later time point. The other strategic collaboration is with Sarah Cannon Research Institute (SCRI) that brings together Boehringer Ingelheim’s extensive experience in cancer drug development and SCRI’s expertise in designing and executing clinical trials of investigational oncology drugs.
Acorda Therapeutics, Inc. Gains Title To All Shares In Biotie Therapies Corp. And The Shares Will Delist From Nasdaq Helsinki
On September 30, 2016 Acorda Therapeutics, Inc. (Nasdaq: ACOR) ("Acorda") reported that it had lodged security approved by the Arbitral Tribunal and thus gained title to all the shares in Biotie Therapies Corp. (Nasdaq Helsinki: BTH1V) ("Biotie") in accordance with Chapter 18, Section 6 of the Finnish Companies Act (Press release, Acorda Therapeutics, SEP 30, 2016, View Source [SID:SID1234515532]). After the security has been lodged, the minority shareholders of Biotie being parties to the redemption proceedings are only entitled to receive the redemption price and the interest payable thereon. Upon application by Biotie, Nasdaq Helsinki Ltd ("Nasdaq Helsinki") has on 25 August 2016 decided that the Biotie shares will be delisted from the Official List of Nasdaq Helsinki upon title to all shares in Biotie having been transferred to Acorda. The quoting of the Biotie shares on Nasdaq Helsinki will thus cease in accordance with a separate release to be published by Nasdaq Helsinki.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
LabCorp Subsidiary Sequenom, Inc. Announces Early Tender Results for Tender Offers and Successful Completion of Consent Solicitations for 5% Convertible Senior Notes Due 2017 and 5% Convertible Senior Exchange Notes Due 2018
On September 30, 2016 Sequenom, Inc. ("Sequenom"), a wholly-owned subsidiary of Laboratory Corporation of America Holdings (LabCorp) (NYSE: LH), reported the results, as of 5:00 p.m., New York City time, on September 29, 2016 (the "Early Tender and Consent Payment Deadline"), of (A) the cash tender offers (the "Tender Offers") for any and all of the outstanding 5% Convertible Senior Notes Due 2017 (CUSIP No. 817337 AB4, the "2017 Notes") and 5% Convertible Senior Exchange Notes Due 2018 (CUSIP No. 817337 AC2, the "2018 Notes" and, together with the 2017 Notes, the "Notes") issued by Sequenom, and (B) the solicitations (the "Consent Solicitations") of consents of the holders of Notes (the "Consents") to enact certain proposed amendments (the "Proposed Amendments") to the indentures governing the Notes to eliminate various reporting obligations and restrictive provisions related to the incurrence of indebtedness, as well as make certain other changes in the indentures (Press release, LabCorp, SEP 30, 2016, View Source;p=RssLanding&cat=news&id=2207126 [SID:SID1234515520]). The Tender Offers will expire at 5:00 p.m., Eastern Time, on Monday, October 17, 2016, unless extended or terminated (the "Expiration Date").
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
As of the Early Tender and Consent Payment Deadline, (i) a total of $44,841,000 aggregate principal amount of the outstanding 2017 Notes, representing approximately 99.647% of the outstanding 2017 Notes, were validly tendered (and not validly withdrawn) and (ii) a total of $85,000,000 aggregate principal amount of the outstanding 2018 Notes, representing 100.00% of the outstanding 2018 Notes, were validly tendered (and not validly withdrawn) in the Tender Offers. All tendered Notes were accompanied by Consents to the Proposed Amendments.
As a result, as of the Early Tender and Consent Payment Deadline, Sequenom received the requisite Consents from holders of at least a majority of the outstanding principal amount of both series of Notes to meet the Consent Condition and to adopt the Proposed Amendments. On September 29, 2016, Sequenom and the trustee for the Notes entered into a supplemental indenture to each of the indentures governing the 2017 Notes and the 2018 Notes (the "Supplemental Indentures"), giving effect to the Proposed Amendments. The Supplemental Indentures are binding as of their execution and will become operative on the settlement date of the Tender Offers (the "Settlement Date"), which is expected to occur on October 20, 2016.
Sequenom will accept for purchase such amount of 2017 Notes and 2018 Notes properly tendered and not validly withdrawn in the Tender Offers as of the Early Tender and Consent Payment Deadline. Holders whose 2017 Notes were validly tendered and accompanied by a Consent on or before the Early Tender and Consent Payment Deadline, and not withdrawn, will receive, in respect of each $1,000 principal amount of 2017 Notes, the "2017 Total Consideration" of $1,037.50 plus Accrued Interest (such price being rounded to the nearest $0.01 per $1,000 principal outstanding amount of Notes) on the Settlement Date. Holders whose 2018 Notes were validly tendered and accompanied by a Consent on or before the Early Tender and Consent Payment Deadline, and not withdrawn, will receive, in respect of each $1,000 principal amount of 2018 Notes, the "2018 Total Consideration" of $1,046.25 plus Accrued Interest (such price being rounded to the nearest $0.01 per $1,000 principal outstanding amount of Notes) on the Settlement Date.
Holders who validly tender their 2017 Notes after the Early Tender and Consent Payment Deadline but on or prior to the Expiration Date and do not withdraw their tender will not receive the respective Total Consideration but will be eligible to receive, in respect of each $1,000 principal amount of 2017 Notes tendered, the "Purchase Price" of $1,000.00, plus accrued interest to but excluding the Settlement Date. No tenders of Notes will be valid if submitted after the Expiration Date.
The Tender Offers and Consent Solicitations are being made pursuant to an Offer to Purchase and Consent Solicitation Statement, dated September 16, 2016 (as supplemented on September 22, 2016, and as amended or further supplemented from time to time, the "Offer to Purchase") and the accompanying Consent and Letter of Transmittal.
Barclays is the Dealer Manager and Solicitation Agent for the Tender Offers and Consent Solicitations and may be contacted at 1-888-610-5877 (toll free) or 212-526-7255. Requests for documents may be directed to Morrow Sodali Global, LLC, the Information Agent, at 1-203-658-9400 for banks and brokers or 1-800-662-5200 (toll free) for Holders and all others.
This announcement is not an offer to purchase or the solicitation of an offer to sell the Notes or a solicitation of Consents. The Tender Offers for the Notes and the related Consent Solicitations are only being made pursuant to the Offer to Purchase and the related Consent and Letter of Transmittal. Holders of the Notes should read the Offer to Purchase and the Consent and Letter of Transmittal carefully prior to making any decision with respect to the Tender Offers and Consent Solicitations because they contain important information.
This announcement has been issued by and is the sole responsibility of Sequenom, Inc. In accordance with normal practice, Barclays expresses no opinion on the merits of the Tender Offers or the Consent Solicitations, nor does it accept any responsibility for the accuracy or completeness of this announcement or any other document prepared in connection with the Tender Offers or the Consent Solicitations.
Cancer Research UK, MSD and Verastem Collaborate to Trial New Combination of Immunotherapy Drugs
On September 30, 2016 CANCER RESEARCH UK reported its first cross-company deal as part of its Experimental Cancer Medicine Centre (ECMC) Combinations Alliance (Press release, Verastem, SEP 30, 2016, View Source [SID:SID1234515522]). Schedule your 30 min Free 1stOncology Demo! MSD, Verastem, Inc. and Cancer Research UK will trial a new combination of immunotherapy drugs in mesothelioma, non small cell lung and pancreatic cancers. The trial will run through the ECMC network at centres in Edinburgh-Dundee, Southampton, Glasgow, Leicester and Belfast.
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The phase Ib/IIa trial will investigate whether a focal adhesion kinase (FAK) inhibitor drug from Verastem called VS-6063 (defactinib)* can boost the effectiveness of a PD-1 immunotherapy drug from MSD called Keytruda (pembrolizumab).
It is based on discoveries by scientists at the Edinburgh Cancer Research UK Centre at the University of Edinburgh who showed that inhibiting FAK can release the cancer immune response. Defactinib may be able to take down a barrier of immune cells which are tricked into protecting the cancer cells while pembrolizumab can activate cancer-killing immune cells to attack those exposed cancer cells.
Around 50-60 cancer patients will take the drug combination, starting with a small dose and building this up to find what is safe. The scientists will also study how the treatments target the cancers and what effects the drug combination has on the tumours.
The trial will open between late 2016 and early 2017. It will be managed by the Cancer Research UK clinical trials unit in Glasgow and co-sponsored by the University of Glasgow and NHS Greater Glasgow and Clyde.
Dr Mercia Page, medical director of oncology at MSD, said: "We look forward to working with Cancer Research UK and Verastem on this promising combination. Strategic collaborations such as this reinforce the commitment we have to bringing a range of new treatments to the forefront, helping people with cancer who need a number of options available to them."
Dr Greg Berk, Verastem chief medical officer, said: "Combining defactinib and MSD’s pembrolizumab through the Combinations Alliance expands our potential to deliver transformative therapies to patients with many types of cancer.
"We are delighted to be working with the Combinations Alliance, MSD, and world class scientists and medical centres throughout the UK on this trial. This study will build on the single agent activity of defactinib observed in early clinical trials in patients with non-small cell lung cancer and other tumour types, and follows from substantial preclinical research which has demonstrated that FAK inhibition optimizes the tumour immune balance and potentiates efficacy of PD-1 checkpoint inhibition."
Dr Ian Walker, director of clinical research at Cancer Research UK, said: "It’s vital that we find new treatments for these three cancers which take tens of thousands of lives each year in the UK and we’re delighted to be working with MSD and Verastem on this.
"Our Combinations Alliance was set up to help develop partnerships between drug development companies and researchers to try new combinations of drugs in the hope of improving treatments and saving more lives from cancer. This is our first success in bringing together two organisations and we hope that this combination of immunotherapy drugs will benefit patients."
Mesothelioma, pancreatic and non small cell lung cancers have very low survival – with more than half (60 per cent) of mesothelioma patients, more than three quarters (79 per cent) of pancreatic cancer patients and two thirds (68 per cent) of lung cancer patients dying within a year of diagnosis in England and Wales.*
Trial co-lead Dr Stefan Symeonides, from the University of Edinburgh, said: "Immunotherapy is a very exciting area of cancer research and we’ve seen remarkable benefits from pembrolizumab for some patients with hard-to-treat cancers, like melanoma and lung cancer. We’re hoping that the addition of defactinib will extend those benefits to more patients.
"This work could one day give a new treatment option that saves lives for this group of patients who have few options."