On July 19, 2018 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the Phase III IMpower132 study met its co-primary endpoint of progression-free survival (PFS) and demonstrated that the combination of Tecentriq(atezolizumab) plus chemotherapy (cisplatin or carboplatin plus pemetrexed) reduced the risk of disease worsening or death (PFS) compared to chemotherapy alone in the initial (first-line) treatment of advanced non-squamous non-small cell lung cancer (NSCLC) (Press release, Hoffmann-La Roche, JUL 19, 2018, View Source [SID1234527774]). While a numerical improvement for the co-primary endpoint of overall survival (OS) was observed, statistical significance was not met at this interim analysis, and the study will continue as planned with final OS results expected next year. Safety for the Tecentriq and chemotherapy combination appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination. These data will be presented at an upcoming medical meeting.

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"The IMpower132 study showed Tecentriq plus chemotherapy prolonged the time people with this type of advanced lung cancer lived without their disease worsening. We will discuss these results with health authorities," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development.

About the IMpower132 study
IMpower132 is a Phase III, open-label, randomised study evaluating the efficacy and safety of Tecentriq plus chemotherapy (cisplatin or carboplatin and pemetrexed) versus chemotherapy alone in chemotherapy-naïve patients with advanced non-squamous NSCLC. The study enrolled 578 people who were randomised equally (1:1) to receive:

Tecentriq in combination with cisplatin or carboplatin and pemetrexed (Arm A), or
Cisplatin or carboplatin and pemetrexed (Arm B, control arm)
During the treatment-induction phase, people received Tecentriq, pemetrexed and investigator’s choice of either cisplatin or carboplatin on Day 1 of every three weeks for a dosing period of four or six cycles. People who experienced clinical benefit during the induction phase began maintenance therapy until disease progression.

The co-primary endpoints were:

PFS as determined by the investigator using RECIST v1.1
OS
IMpower132 met its PFS co-primary endpoint as per the study protocol.

About NSCLC
Lung cancer is the leading cause of cancer death globally.1 Each year 1.59 million people die as a result of the disease; this translates into more than 4,350 deaths worldwide every day.2 Lung cancer can be broadly divided into two major types: NSCLC and small cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases.2 NSCLC comprises non-squamous and squamous-cell lung cancer, the squamous form of which is characterised by flat cells covering the airway surface when viewed under a microscope. The squamous form tends to grow near the centre of the lung, and accounts for approximately 25-30% of all NSCLC cases.3

About Tecentriq
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T cells. Tecentriq has the potential to be used as a foundational combination partner with cancer immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.

Currently, Roche has eight Phase III lung cancer studies underway, evaluating Tecentriq alone or in combination with other medicines.

Tecentriq is already approved in the European Union, United States and more than 70 countries for people with previously treated metastatic NSCLC and for certain types of untreated or previously treated metastatic urothelial carcinoma (mUC).

About Roche in cancer immunotherapy
For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer.

By applying our seminal research in immune tumour profiling within the framework of the Roche-devised cancer immunity cycle, we are accelerating and expanding the transformative benefits with Tecentriq to a greater number of people living with cancer. Our cancer immunotherapy development programme takes a comprehensive approach in pursuing the goal of restoring cancer immunity to improve outcomes for patients.

On July 18, 2018 Alimera Sciences (NASDAQ: ALIM), a leader in the commercialization and development of prescription ophthalmic pharmaceuticals, reported that it will release its financial results for the second quarter ended June 30, 2018, after the close of the financial markets on Monday, July 30, 2018 (Press release, Alimera Sciences, JUL 18, 2018, View Source [SID1234527772]).

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An accompanying conference call will be hosted by Dan Myers, Chief Executive Officer and Rick Eiswirth, President and Chief Financial Officer to discuss the results. The call will be held at 9:00 AM ET, on Tuesday, July 31, 2018. Please refer to the information below for conference call dial-in information and webcast registration.

Conference Details

Conference date: Tuesday July 31, 2018 9:00 AM ET

Conference dial-in: 877.269.7756

International dial-in: 201.689.7817

Conference Call Name: Alimera Sciences Second Quarter 2018 Results Call

On July 18, 2018 Vyriad Inc., a clinical-stage, privately held biotechnology company focused on the development of powerful first-in class oncolytic virotherapies, is reported that collaboration agreement with Merck KGaA, Darmstadt, Germany, and Pfizer to expand its ongoing Phase 1 clinical trial program in solid tumors to include a combination study of its lead asset, Voyager-V1, with avelumab*, a human anti-PD-L1 antibody (Press release, Vyriad, JUL 18, 2018, View Source [SID1234527771]). For more information on this novel immuno-oncology combination study, please see clinicaltrials.gov.

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"We are delighted to be working with Merck KGaA, Darmstadt Germany, and Pfizer on this innovative combination treatment approach," said Stephen Russell, M.D., Ph.D., CEO of Vyriad. "Voyager-V1 is being administered to inflame the tumors, and avelumab has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models."

"We are encouraged by the potential of Voyager-V1, which has demonstrated early clinical activity in patients with solid tumors," said Alise Reicin, Head of Global Clinical Development at the Biopharma business of Merck KGaA, Darmstadt, Germany, which operates in the U.S. and Canada as EMD Serono. "We look forward to investigating how combining Voyager-V1 with avelumab may advance patient care."

"A primary focus of our clinical development program for avelumab is to evaluate the role and potential of immunotherapy combination regimens, in an effort to support patients with challenging cancers," said Chris Boshoff, M.D., Ph.D., Senior Vice President and Head of Immuno-Oncology, Early Development and Translational Oncology, Pfizer Global Product Development. "We look forward to working with Vyriad to explore this novel combination for patients with solid tumors."

Avelumab has received accelerated approval** by the U.S. Food and Drug Administration (FDA) for the treatment of patients with metastatic Merkel cell carcinoma (MCC) and previously treated patients with locally advanced or metastatic urothelial carcinoma (mUC), and is under further clinical evaluation across a range of tumor types under a global strategic alliance between Merck KGaA, Darmstadt, Germany, and Pfizer.

*Avelumab is under clinical investigation for treatment of various solid tumors and has not been demonstrated to be safe and effective for this indication. There is no guarantee that avelumab will be approved for specific solid tumors by any health authority worldwide.

About Voyager-V1

Voyager-V1 (VSV-IFNβ-NIS) is derived from Vesicular Stomatitis Virus (VSV), a bullet-shaped, negative-sense RNA virus with low human seroprevalence, specifically engineered to replicate selectively in and kill human cancer cells. Voyager-V1 encodes human IFNβ to boost antitumoral immune responses and increase tumor specificity, plus the thyroidal sodium iodide symporter NIS to allow imaging of virus spread. Three first-in-human Phase 1 clinical studies of Voyager-V1 are exploring intravenous and intratumoral routes of administration.

About Avelumab

Avelumab is a human anti-programmed death ligand-1 (PD-L1) antibody. Avelumab has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, avelumab has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models.1-3 Avelumab has also been shown to induce NK cell-mediated direct tumor cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro.3-5 In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab.

Avelumab is currently being evaluated in the JAVELIN clinical development program, which involves at least 30 clinical programs, including seven Phase III trials and nearly 8,300 patients across more than 15 different tumor types. For a comprehensive list of all avelumab trials, please visit clinicaltrials.gov.

Indications in the U.S.**

The U.S. Food and Drug Administration (FDA) granted accelerated approval for avelumab (BAVENCIO) for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (mMCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Important Safety Information from the U.S. FDA-Approved Label

The warnings and precautions for avelumab (BAVENCIO) include immune-mediated adverse reactions (such as pneumonitis, hepatitis, colitis, endocrinopathies, nephritis and renal dysfunction and other adverse reactions), infusion-related reactions and embryo-fetal toxicity.

Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO for mMCC and patients with locally advanced or metastatic UC include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, peripheral edema, decreased appetite/hypophagia, urinary tract infection and rash.

For full prescribing information and medication guide for BAVENCIO, please see www.BAVENCIO.com.

Alliance between Merck KGaA, Darmstadt, Germany, and Pfizer Inc., New York, U.S.

Immuno-oncology is a top priority for Merck KGaA, Darmstadt, Germany, and Pfizer Inc. The global strategic alliance between Merck KGaA, Darmstadt, Germany, and Pfizer Inc., New York, U.S., enables the companies to benefit from each other’s strengths and capabilities and further explore the therapeutic potential of avelumab, an anti-PD-L1 antibody initially discovered and developed by Merck KGaA, Darmstadt, Germany. The immuno-oncology alliance will jointly develop and commercialize avelumab and advance Pfizer’s PD-1 antibody. The alliance is focused on developing high-priority international clinical programs to investigate avelumab as a monotherapy, as well as in combination regimens, and is striving to find new ways to treat cancer.

On July 18, 2018 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health") reported that it will release its second-quarter 2018 financial results on Tuesday, Aug. 7, 2018 (Press release, Valeant, JUL 18, 2018, View Source [SID1234527770]). Bausch Health will host a conference call and live web cast at 8:00 a.m. EDT to discuss the results and provide a business update. All materials will be made available on the investor relations section of the Bausch Health web site prior to the start of the call.

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Conference Call Details
Date: Tuesday, Aug. 7, 2018
Time: 8:00 a.m. EDT
Webcast: View Source
Participant Event Dial-in: (844) 428-3520 (North America)
(409) 767-8386 (International)
Participant Passcode: 1378128
Replay Dial-in: (855) 859-2056 (North America)
(404) 537-3406 (International)
Replay Passcode:
1378128 (replay available until Oct. 7, 2018)

On July 18, 2018 Sanofi and REVOLUTION Medicines, Inc. reported an exclusive worldwide partnership to develop and commercialize targeted therapies, based on the biology of the cellular enzyme SHP2, for patients with non-small lung cancer and other types of cancer carrying certain mutations (Press release, Sanofi Genzyme, JUL 18, 2018, View Source [SID1234527769]). This collaboration builds on precision oncology discoveries by REVOLUTION Medicines and preclinical development of RMC-4630, the company’s lead small molecule inhibitor of SHP2, and will apply Sanofi’s expertise in oncology research and drug development.

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In the collaboration, the companies will jointly develop SHP2 inhibitors, which are designed to reduce cell growth signaling that is overactive in cancer. Both parties will contribute to the research and development program, with REVOLUTION Medicines continuing to lead research and early clinical development, and Sanofi leading later development activities for the program. The companies expect to begin first-in-human clinical trials with RMC-4630 in the second half of 2018.

"REVOLUTION Medicines has made great progress in elucidating the role of SHP2 in cancer and advancing RMC-4630 into clinical development," said Mark A. Goldsmith, M.D., Ph.D., president and chief executive officer of REVOLUTION Medicines. "The exciting collaboration benefits from the innovation culture and scientific capabilities of our team and the proven oncology research and development capabilities and global commercial resources of Sanofi to continue this momentum and maximize the potential impact for cancer patients."

"This agreement demonstrates our continued commitment to develop new therapies for patients living with cancer," said Joanne Lager, head of oncology development at Sanofi. "We look forward to working with REVOLUTION Medicines to advance investigational therapies that could provide a new way to treat patients with non-small cell lung cancer and other cancers that have specific types of genetic mutations."

REVOLUTION Medicines will receive an upfront fee of $50 million, and Sanofi will cover R&D costs for the joint SHP2 program. Sanofi will receive an exclusive worldwide license for global commercialization of any approved products targeting SHP2, subject to a U.S. co-promote option for REVOLUTION Medicines. The companies will enter into a 50/50 profit and loss share arrangement in the U.S., and REVOLUTION Medicines will receive a tiered royalty reaching mid-double digits on sales in other markets. REVOLUTION Medicines could also receive more than $500 million in development and regulatory milestone payments.

The Role of SHP2 in Cancer

SHP2 (PTPN11), a cellular enzyme in the protein tyrosine phosphatase family, plays an important role in multiple forms of cancer and in regulating the immune system. Recently REVOLUTION Medicines reported discoveries about the regulation by SHP2 of a cell growth signaling pathway, known as the RAS-MAP kinase pathway, that frequently is hyperactive in human cancers. The research revealed that some mutated forms of proteins in the RAS-MAP kinase pathway depend on SHP2 for their oncogenic activity, and that small molecule inhibitors of SHP2 designed by the company can reduce their tumorigenic effects.