On April 24, 2018 In conjunction with DURECT Corporation’s(Nasdaq: DRRX) reported that its first quarter 2018 financial results press release, you are invited to listen to a conference call that will be broadcast live over the internet on Wednesday, May 2, 2018 at 4:30 pm Eastern Time (1:30 pm Pacific Time) (Press release, DURECT, APR 24, 2018, http://investors.durect.com/phoenix.zhtml?c=121590&p=irol-newsArticle&ID=2344347 [SID1234525651]).

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A live audio webcast of the presentation will be available by accessing DURECT’s homepage at www.durect.com and clicking "Investor Relations." If you are unable to participate during the live webcast, the call will be archived on DURECT’s website under Audio Archive in the "Investor Relations" section.

The filing is based on data from the Phase III KEYNOTE-189 trial, which showed that first-line use of Keytruda (pembrolizumab) in combination with pemetrexed (Lilly’s Alimta) and cisplatin or carboplatin slashed the risk of death by 51 percent compared with chemotherapy alone (Press release, PharmaTimes, APR 24, 2018, View Source [SID1234525615]).

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An overall survival benefit was observed regardless of PD-L1 expression, the firm noted.

"We are very pleased that the centralized review process is underway, and are hopeful that this new combination regimen will soon become available for appropriate patients in Europe who have been diagnosed with metastatic lung cancer," noted Dr Roger Perlmutter, president, Merck Research Laboratories.

If approved by the European Medicines Agency, this would mark the third indication for Keytruda in metastatic NSCLC to be approved in Europe based on overall survival data.

MSD initially pulled back its European application to market the combo in October last year, with media reports at the time suggesting that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) was reluctant to back approval.

That filing was based on a cohort of the KEYNOTE-021 trial, which MSD insisted "demonstrated significant improvements in overall response rate (ORR) and progression-free survival (PFS) for the Keytruda combination regimen compared to chemotherapy alone".

Analysts at Goldman Sachs reportedly said this week that Keytruda could be a $16-billion asset by 2025, pushing MSD’s stock to a three-month high, according to Investor’s Business Daily.

AstraZeneca has come up short in another lung cancer trial of its immuno-oncology combo, this time in patients who’ve failed on two prior treatments (Press release, AstraZeneca, APR 24, 2018, View Source;utm_medium=rss [SID1234525635]).

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But investors shouldn’t use the outcome to predict the forthcoming results of a closely watched first-line study, analysts say.

Tuesday, the British drugmaker said its PD-L1 med Imfinzi and candidate tremelimumab had failed to improve survival in third-line patients whose tumors didn’t express PD-L1. There was a bright spot, though: A substudy that pitted solo Imfinzi against chemo in PD-L1-positive patients showed a "clinically meaningful" difference for the AZ drug in the risk of death.

The results weren’t terribly surprising to analysts; Bernstein’s Tim Anderson, for one, said in a note to clients that he thought the trial, dubbed Arctic, "was likely to yield mixed results (and it did)."

And the way he sees it, that’s not such a bad thing. Overall, "the field has moved on," he said, calling Arctic "basically the hangover from a now abandoned hypothesis" that PD-L1/CTLA4 pairings such as AZ’s will extend benefits to the PD-L1 negative population.

ODDO BHF’s Pierre Corby wrote in his own note to clients that removing the combination from models would have "minimum impact."

RELATED: AstraZeneca’s Mystic shortfall is an immuno-oncology shake-up for Bristol-Myers and a bolster for Merck and Roche

And while investors may be tempted to take the outcome as a sign that the Imfinzi-tremelimumab combo is destined for failure in first-line, PD-L1-positive patients—the all-important population in the I-O market—they shouldn’t, Anderson said.

"That outcome is certainly not foreshadowed" by the miss in PD-L1 negative patients, he wrote.

If there’s any readthrough to Mystic, AstraZeneca’s first-line trial, it’s that Imfinzi still holds promise as a monotherapy, Anderson figures.

"We continue to believe that Imfinzi is likely is show an OS benefit in 1L PD-L1(+) patients, and obtain a (modest) foothold in the market," he wrote.

RELATED: 2018 is here. Now get ready for ‘market-defining’ I-O readouts

Of course, it’ll still be a while before industry watchers have that data, which is slated to arrive in the second half of the year. And in the meantime, there will be plenty of other key I-O news from companies including Merck and Roche that should keep investors busy.

On April 24, 2018 REVOLUTION Medicines, Inc., a drug discovery and development company focused on frontier cancer targets, reported it has raised $56 million in a Series B financing to support its ongoing R&D programs and general business activities (Press release, Revolution Medicines, APR 24, 2018, View Source [SID1234525652]). The financing was supported by a syndicate of premier life sciences investors led by Nextech Invest, an oncology-focused investment firm, and included participation from Casdin Capital, Schroder Adveq, The Column Group, Third Rock Ventures and additional undisclosed institutional investors.

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In addition, the company announced the expansion of its leadership team with the appointment of Ryan Martins as chief financial officer; Xiaolin Wang, D.Sc., as senior vice president, clinical development; and Hirdesh Uppal, D.V.M., Ph.D., as vice president, development sciences. Thilo Schroeder, Ph.D., partner at Nextech Invest, and Barbara Weber, M.D., chief executive officer of Tango Therapeutics, joined the company’s board of directors.

"We appreciate the strong support shown by our founding and new investors in this significant financing that will fuel the advancement of our exciting SHP2 program and innovative pipeline," said Mark A. Goldsmith, M.D., Ph.D., president and chief executive officer at REVOLUTION Medicines. "The raise of new capital, expansion of our executive team and board with seasoned leaders, and multiple presentations about progress in our SHP2 program at the recent AACR (Free AACR Whitepaper) conference all reflect enormous momentum in our effort to outsmart cancer."

Leadership Team and Board of Directors Appointments

Mr. Martins joins REVOLUTION Medicines from Ultragenyx, where he served as vice president, finance, corporate strategy and investor relations with responsibility for capital raising, investor relations, financial and competitive analysis, strategic planning and business development. Mr. Martins was previously a biotechnology analyst at investment banks including Lehman Brothers, Barclays, Lazard and Jefferies.
Dr. Wang joins the company from Acerta Pharma, where she held a senior leadership position in clinical development and was instrumental in the recent approval of acalabrutinib (Calquence). Dr. Wang previously served in leadership positions in clinical development and biometrics at Genentech and Geron.
Dr. Uppal joins REVOLUTION Medicines from Medivation, where he led translational medicine and diagnostics until the company’s acquisition by Pfizer. Prior to Medivation, Dr. Uppal served in development roles at Roche and Genentech.
Dr. Schroeder is a partner at Nextech Invest. He has served as director or observer on the boards of Blueprint Medicines, IDEAYA Bioscience, and Peloton Therapeutics, and previously conducted research on designed ankyrin repeat proteins (DARPins) as specific protein inhibitors at the University of Zurich.
Dr. Weber is chief executive officer of Tango Therapeutics. Prior to Tango, she led oncology translational medicine at Novartis, oncology discovery and translational medicine at GlaxoSmithKline, the University of Pennsylvania Cancer Center Breast Cancer Program and cancer genomics at the Abramson Cancer Research Institute.
"I am very enthusiastic about the high-quality cancer drug discovery and development work being done by REVOLUTION Medicines and am pleased to support this world-class team to help advance the company’s mission on behalf of patients in need," said Dr. Schroeder.

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Media Contact:
Katie Engleman
W2O Group
910-509-3977
[email protected]

On April 24, 2018 AstraZeneca and MedImmune, reported its global biologics research and development arm, reported high-level results from the Phase III ARCTIC trial in patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least two prior treatments (Press release, AstraZeneca, 24 24, 2018, View Source [SID1234525617]). This randomised, open-label, multi-centre trial assessed the efficacy and safety of the combination of Imfinzi (durvalumab) plus tremelimumab, as well as Imfinzi and tremelimumab monotherapies, versus standard-of-care chemotherapy (SoC) in patients with PDL1-low/negative NSCLC (sub-study B), and Imfinzi monotherapy versus SoC in patients with PDL1-high NSCLC (sub-study A).

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In sub-study B, the combination of Imfinzi plus tremelimumab in patients with PD-L1 low/negative NSCLC did not meet the primary endpoints of a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) and overall survival (OS) compared to SoC. Activity and safety of monotherapy arms of sub-study B were consistent with prior published data.

Sub-study A was not powered for statistical significance; however, Imfinzi monotherapy showed a clinically-meaningful reduction in the risk of death compared to chemotherapy.

Full data from the ARCTIC trial will be presented at a forthcoming medical meeting.

Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer, said: "While we are disappointed that the combination of Imfinzi plus tremelimumab did not result in a statistically-significant survival benefit in this heavily pre-treated patient population, we are encouraged by the activity of Imfinzi monotherapy observed in this trial and look forward to presenting the full data from the ARCTIC trial at an upcoming medical meeting."

AstraZeneca recently received approval from the US FDA for Imfinzi for the treatment of patients with unresectable, Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.

NOTES TO EDITORS
About ARCTIC

The ARCTIC trial was a randomised, open-label, multi-centre, global Phase III trial containing two sub-studies: sub-study A (1:1 randomisation of patients with PDL1-high tumours to Imfinzi (durvalumab) vs. SoC) and sub-study B (2:3:1:2 randomisation of patients with PDL1-low/negative tumours to Imfinzi monotherapy, Imfinzi plus tremelimumab or tremelimumab vs SoC). Tumour PD-L1 expression was assessed with the Ventana PD-L1 (SP263) assay with PD-L1 high defined as ≥25% of tumour cells with membrane staining.

About Imfinzi

Imfinzi is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

In February 2018, Imfinzi received US FDA approval for the treatment of patients with unresectable, Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. Imfinzi also received accelerated approval in the US for the treatment of patients with locally-advanced or metastatic urothelial carcinoma, who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery.

As part of a broad development programme, Imfinzi is also being tested as a monotherapy and in combination with tremelimumab, an anti-CTLA-4 monoclonal antibody and potential new medicine, as a first-line treatment for patients with NSCLC, small cell lung cancer, locally-advanced or metastatic urothelial carcinoma, head and neck cancer and other solid tumours.

About tremelimumab

Tremelimumab is a human monoclonal antibody and potential new medicines that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Tremelimumab blocks the activity of CTLA-4, contributing to T cell activation and boosting the immune response to cancer. Tremelimumab is being tested in an extensive clinical-trial programme in combination with Imfinzi in NSCLC, locally-advanced or metastatic urothelial carcinoma, head and neck cancer, liver cancer and blood cancers.

About AstraZeneca in NSCLC

Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-third of all cancer deaths and more than breast, prostate and colorectal cancers combined.

AstraZeneca has a comprehensive portfolio of approved and potential new medicines in late-stage clinical development for the treatment of NSCLC across all stages of disease and lines of therapy. We aim to address unmet needs of patients with EGFR-mutated tumours as a genetic driver of disease, which occur in 10-15% of NSCLC patients in the US and EU and 30-40% of NSCLC patients in Asia, with our approved medicines Iressa and Tagrisso and ongoing FLAURA and ADAURA trials. Our extensive late-stage immuno-oncology programme focuses on 75-80% of patients with NSCLC without a known genetic mutation. Our portfolio includes Imfinzi, an anti-PDL1 antibody, which is in development as monotherapy (ADJUVANT, PACIFIC, MYSTIC, PEARL and ARCTIC trials) and in combination with tremelimumab (MYSTIC, NEPTUNE, ARCTIC and POSEIDON trials).

About AstraZeneca’s Approach to Immuno-Oncology

Immuno-Oncology (IO) is a therapeutic approach designed to stimulate the body’s immune system to attack tumours. At AstraZeneca and MedImmune, our biologics research and development arm, our IO portfolio is anchored by immunotherapies that have been designed to overcome anti-tumour immune suppression. We believe that IO-based therapies will offer the potential for life-changing cancer treatments for the clear majority of patients.

We are pursuing a comprehensive clinical-trial programme that includes Imfinzi (anti-PD-L1) as monotherapy and in combination with tremelimumab (anti-CTLA-4) in multiple tumour types, stages of disease, and lines of therapy, using the PD-L1 biomarker as a decision-making tool to define the best potential treatment path for a patient. In addition, the ability to combine our IO portfolio with small, targeted molecules from across our Oncology pipeline, and with those of our research partners, may provide new treatment options across a broad range of tumours.

About AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly-growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advancing Oncology as a growth driver for AstraZeneca, focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy as illustrated by our investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and, one day, eliminate cancer as a cause of death.

About MedImmune

MedImmune is the global biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of small-molecule and biologic prescription medicines. MedImmune is pioneering innovative research and exploring novel pathways across Oncology; Respiratory; Cardiovascular, Renal & Metabolic Diseases; and Infection and Vaccines. The MedImmune headquarters is located in Gaithersburg, MD, one of AstraZeneca’s three global R&D centres, with additional sites in Cambridge, UK, and Mountain View, CA. For more information, please visit www.medimmune.com.