On September 27, 2019 The Janssen Pharmaceutical Companies of Johnson & Johnson reported updated, longer-term results from the pivotal Phase 3 SPARTAN study following a second interim analysis (Press release, Johnson & Johnson, SEP 27, 2019, View Source [SID1234539860]). Treatment with ERLEADA (apalutamide) plus androgen deprivation therapy (ADT) in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who were at high-risk of developing metastases, resulted in a 25 percent reduction in the risk of death compared with placebo plus ADT [HR=0.75; 95 percent CI, 0.59–0.96; p=0.0197 (to reach statistical significance, a p-value of p<0.0121 needed to be observed)].1,2

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The updated findings showed overall survival (OS) results supported the first interim analysis, despite a crossover of placebo patients to the apalutamide treatment group.1,2 Results were presented in an oral session at the 2019 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress (abstract #843O), and simultaneously published in Annals of Oncology.

At the second interim analysis, a longer median follow-up of 41 months, four-year OS rates were 72.1 percent for patients treated with apalutamide and 64.7 percent for patients treated with placebo.1,2 The OS benefit of apalutamide was consistent across baseline subgroups, such as race, prior treatments, baseline PSA and performance status.1,2

This interim analysis took place when 67 percent of the required OS events had been observed, compared with the original report when only 24 percent of required OS events had occurred (HR=0.70; 95 percent CI, 0.47–1.04; p=0.07).1,2 After unblinding the study, and prior to the second interim analysis, 76 non-progressing patients in the placebo group (19 percent of all placebo patients) crossed over to open-label apalutamide for an average of 15 months; the OS rates in the placebo group included those patients who were crossed over to apalutamide treatment, thereby underestimating the true treatment effect.1,2 The rates of treatment-emergent adverse events for apalutamide at the second interim analysis were consistent with rates previously reported.1,2 In the SPARTAN study, the most common adverse events (≥10 percent) were fatigue, hypertension, rash, diarrhea, nausea, weight decreased, arthralgia, falls, hot flush, decreased appetite, fracture and peripheral edema.3

"The data presented at ESMO (Free ESMO Whitepaper) 2019 add to the growing body of evidence demonstrating a trend for survival benefit achieved by apalutamide in patients with high-risk nmCRPC. This interim analysis for survival is in line with the initial data presented for all androgen signaling inhibitors in this disease setting. Hence all data presented to date reinforce the benefit of treating men with non-metastatic (by conventional imaging) castration-resistant prostate cancer," said Dr Eleni Efstathiou, MD, PhD, Associate Professor, Department of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, U.S. "For nmCRPC patients who remain at risk of their cancer spreading, and the clinicians that treat them, these data are very encouraging as they show the potential of this treatment in improving survival rates and slowing progression to a fatal stage of the disease – the ultimate goal when treating this population."

Initial results from the SPARTAN trial were presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Annual Meeting Cancers Symposium (ASCO GU), and simultaneously published in The New England Journal of Medicine.4,5

"Despite many advances in the treatment of prostate cancer in recent years, there remains a high unmet need, particularly in the treatment of those patients who are at risk of their disease progressing to the most advanced form; the metastatic disease stage," said Dr Joaquín Casariego, Janssen Therapeutic Area Lead Oncology for Europe, Middle East & Africa, Janssen-Cilag S.A.. "We are very excited to share these new data from the SPARTAN trial, which reinforces the importance of apalutamide as a treatment option for patients with high-risk nmCRPC, for whom delaying the onset of metastases becomes a crucial objective in their disease journey. We will persist in our efforts to improve outcomes for patients through our robust research programme and remain committed to achieving our goal of making prostate cancer a manageable or even a curable disease."

-ENDS-

About the SPARTAN study

SPARTAN (NCT01946204) was a Phase 3, randomised, double-blind, placebo-controlled, multicentre study that evaluated ERLEADA (apalutamide) in combination with ADT in patients with high-risk nmCRPC with a rapidly rising PSA (PSA Doubling Time ≤10 months).4 The SPARTAN study enrolled 1,207 patients who were randomised 2:1 to receive either apalutamide orally at a dose of 240 mg once daily in combination with ADT (n=806) or placebo once daily in combination with ADT (n=401).4 Study results were initially reported at the 2018 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium and published in The New England Journal of Medicine.4,5

In the SPARTAN study, the most common adverse reactions (≥10 percent) were fatigue, hypertension, rash, diarrhea, nausea, decreased weight, arthralgia, falls, hot flushes, decreased appetite, bone fractures and peripheral edema.1

About non-metastatic castration-resistant prostate cancer

Non-metastatic castration-resistant prostate cancer (nmCRPC) refers to a disease stage when the cancer no longer responds to treatments that lower testosterone but has not yet been discovered in other parts of the body using a total body bone scan and CT/MRI scan.6 Features include: lack of detectable metastatic disease; rapidly rising prostate-specific antigen while on ADT with serum testosterone level below 50 ng/dL.7,8 Ninety percent of patients with nmCRPC will eventually develop metastases, which can lead to pain, fractures and other symptoms.9 The relative five-year survival rate for patients diagnosed at a distant-stage prostate cancer is 30 percent.10 It is critical to delay the development of metastasis in patients with nmCRPC.

About ERLEADA (apalutamide)

ERLEADA (apalutamide) is an androgen receptor (AR) inhibitor indicated for use in Europe for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.3 In the U.S. apalutamide is indicated for the treatment of nmCRPC and metastatic castration-sensitive prostate cancer.11 Apalutamide is currently under review by the European Medicines Agency (EMA) for the treatment of metastatic hormone-sensitive prostate cancer.12

On September 27, 2019 Tmunity Therapeutics, Inc., a private clinical-stage biotherapeutics company focused on saving and improving lives by delivering the full potential of next-generation T cell immunotherapy, reported that Christina Coughlin, MD, PhD, Executive Vice President and Chief Medical Officer, and members of the management team plan to participate at the Cantor Fitzgerald 2019 Global Healthcare Conference in New York City on October 3, 2019 (Press release, Tmunity Therapeutics, SEP 27, 2019, View Source [SID1234539859]). The company will webcast a presentation on Tmunity at 4:45 p.m. ET.

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On September 27, 2019 4SC AG (4SC, FSE Prime Standard: VSC) reported the presentation of a number of new important scientific insights into the action of resminostat in cutaneous T-cell lymphoma (CTCL) at the EORTC Cutaneous Lymphoma Task Force Meeting in Athens, 26-28 September 2019 (Press release, 4SC, SEP 27, 2019, View Source [SID1234539858]).

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The majority of CTCL patients suffer from pruritus, which has a significant negative impact on the patient’s quality of life. In CTCL, severity of itching correlates with elevated levels of IL-31, a well described itch mediator in pruritic disorders. Resminostat treatment of CTCL cell lines reduces the level of IL-31 sustainably, indicating a potential to reduce itching in CTCL patients and thereby to improve their health-related quality of life. This will be further evaluated in the ongoing RESMAIN trial (NCT02953301) as key secondary endpoint and IL-31 levels will be measured as part of the biomarker program.

CTCL is characterized by malignant skin-homing T cells with an increasing bias towards the Th2 cell type during disease progression. Genome wide gene expression analysis after treatment of CTCL cell lines with resminostat shows a down regulation of skin homing receptors and of genes associated with disease progression. Interestingly, data presented at the EORTC-CLTF meeting demonstrate that resminostat up-regulates Th1 and down-regulates Th2 associated genes, thus favoring the beneficial Th1-phenotype. Taken together, these data provide insights into the transcriptional effects of resminostat in CTCL and strongly suggest that resminostat has the potential to delay or even prevent disease progression in CTCL.

Natural killer (NK) cells are potent effectors of the anti-tumoral innate defense. Preclinical data is presented demonstrating that resminostat positively promotes NK cell-mediated lysis of cancer cells, suggesting potential for resminostat in combination with opsonizing antibodies as a potential therapy in hematological cancer indications such as CTCL.

Susanne Danhauser-Riedl, M.D., Chief Medical Officer of 4SC, commented: "These data continue to illustrate the mode of action of resminostat in CTCL and underline its potential benefit for CTCL patients. We look forward to gathering more insights in 2020 from our RESMAIN pivotal study of resminostat in CTCL".

On September 27, 2019 AIM ImmunoTech, Inc. (NYSE American: AIM) (the "Company"), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, reported the pricing of an underwritten public offering of (i) 1,740,550 shares of common stock together with common stock warrants (the "common warrants") to purchase 1,740,550 shares of common stock and (ii) 7,148,310 pre-funded warrants, with each pre-funded warrant exercisable for one share of common stock, together with common warrants to purchase 7,148,310 shares of common stock (Press release, Hemispherx Biopharma, SEP 27, 2019, View Source [SID1234539854]). The shares of common stock (or pre-funded warrants, as applicable) and accompanying common warrants are being sold together at a combined public offering price of $0.90 per share. The pre-funded warrants are immediately exercisable and may be exercised at any time until all of the pre-funded warrants are exercised in full. The common warrants will have an exercise price of $0.99 per share, will be immediately exercisable and will expire five years from the date of issuance. The Company has granted the underwriters a 45-day option to purchase up to an additional 1,333,329 shares of common stock and/or 1,333,329 common warrants to cover over-allotments, if any.

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The gross offering proceeds to the Company from the offering, before deducting the underwriting discounts and commissions and other estimated offering expenses, and excluding the exercise of any warrants, are expected to be approximately $8 million. The offering is expected to close on or about September 27, 2019, subject to customary closing conditions.

The Company intends to use the net proceeds from this offering for the manufacturing of Ampligen, ongoing clinical trials and general administrative and operational expenses associated with the Company’s ongoing activities.

A.G.P./Alliance Global Partners is acting as sole book-running manager for the offering.

A registration statement on Form S-1 (No. 333-233657) relating to the offering was filed with the Securities and Exchange Commission ("SEC") and was declared effective on September 25, 2019. The offering is being made only by means of a prospectus. A copy of the final prospectus relating to the offering will be filed with the SEC and may be obtained, when available, by contacting A.G.P./Alliance Global Partners, 590 Madison Avenue, 36th Floor, New York, NY 10022 or via telephone at 212-624-2060 or email: [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

On September 27, 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported positive data from the Phase III IMpower110 study evaluating Tecentriq (atezolizumab) as a first-line (initial) monotherapy compared with cisplatin or carboplatin and pemetrexed or gemcitabine (chemotherapy) in advanced non-squamous and squamous non-small cell lung cancer (NSCLC) without ALK or EGFR mutations (wild-type; WT) (Press release, Hoffmann-La Roche, SEP 27, 2019, View Source [SID1234539853]).1

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The study met its primary endpoint in an interim analysis showing that Tecentriq monotherapy improved overall survival (OS) by 7.1 months compared with chemotherapy alone (median OS=20.2 versus 13.1 months; hazard ratio [HR]=0.595, 95% CI: 0.398–0.890; p=0.0106) in people with high PD-L1 expression (TC3/IC3-WT). Encouraging OS (18.2 versus 14.9 months; HR=0.717, 95% CI: 0.520–0.989) was also observed in people with medium levels of PD-L1 expression (TC2/3 or IC 2/3-WT), however these data did not reach statistical significance at this interim analysis. The study will continue to final analysis for patients with lower levels of PD-L1 expression.1 Safety for Tecentriq appeared to be consistent with its known safety profile and no new safety signals were identified.

"We are excited to share these positive data, showing that Tecentriq alone offers a significant survival benefit over chemotherapy as an initial treatment in people with squamous or non-squamous non-small cell lung cancer with high PD-L1 expression," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "The IMpower110 results demonstrate the potential of first-line Tecentriq monotherapy in certain types of advanced lung cancer, and could provide an additional treatment option for oncologists and the patients that they treat."

These data will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2019 Congress on Friday the 27th of September from 16:00-17:30 CET (Abstract LBA78; Barcelona Auditorium – Hall 2).

Roche will submit these data to global health authorities, including the US Food and Drug Administration (FDA) and European Medicines Agency (EMA), and will discuss how best to bring this option to patients as quickly as possible.

The Tecentriq lung programme currently consists of nine Phase III lung cancer studies as either monotherapy or in combination with other medicines across different types of lung cancer. Roche has an extensive development programme for Tecentriq, including multiple ongoing and planned Phase III studies, across lung, genitourinary, skin, breast, gastrointestinal, gynaecological and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines.

About the IMpower110 study
IMpower110 is a Phase III, randomised, open-label study to evaluate the efficacy and safety of Tecentriq monotherapy compared with cisplatin or carboplatin and pemetrexed or gemcitabine (chemotherapy) in programmed death-ligand 1 (PD-L1)-selected, chemotherapy-naive participants with advanced non-squamous or squamous NSCLC without ALK or EGFR mutations (wild-type; WT).

A total of 572 people (555 WT) were enrolled and were randomised 1:1 to receive:

Tecentriq monotherapy, until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity or death; or
Cisplatin or carboplatin (per investigator discretion) combined with either pemetrexed (non-squamous) or gemcitabine (squamous), followed by maintenance therapy with pemetrexed alone (non-squamous) or best supportive care (squamous) until disease progression, unacceptable toxicity or death.
The primary efficacy endpoint is OS by PD-L1 subgroup (TC3/IC3-WT; TC2/3/ IC2/3-WT; and TC1,2,3/IC1,2,3-WT), as determined by the SP142 assay test. Key secondary endpoints include investigator-assessed progression-free survival (PFS), objective response rate (ORR) and duration of response (DoR).

An overview of the key OS results is below:

TC, tumour cell; IC, tumour-infiltrating immune cells. PD-L1 expression was centrally evaluated with the VENTANA SP142 IHC assay. TC3 or IC3 = TC ≥ 50% or IC ≥ 10% PD-L1+; TC1/2/3 or IC1/2/3 = TC ≥ 1% or IC ≥ 1% PD-L1+; TC2/3 or IC2/3 = TC ≥ 5% or IC ≥ 5% PD-L1+. a Stratified. b Only for descriptive purpose.

*TC2/3 or IC2/3-WT did not cross the pre-specified boundary for statistical significance
**TC1/2/3 or IC1/2/3-WT was not formally tested and did not meet statistical significance

The safety population comprised 286 patients in Arm A and 263 in Arm B. Treatment-related AEs (TRAEs) and Grade 3-4 TRAEs occurred in 60.5% (Arm A) and 85.2% (Arm B), and 12.9% (Arm A) and 44.1% (Arm B), respectively.

About NSCLC
Lung cancer is the leading cause of cancer death globally.2 Each year 1.76 million people die as a result of the disease; this translates into more than 4,800 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.3 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.3

About Tecentriq (atezolizumab)
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is 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 is a cancer immunotherapy (CIT) that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person’s immune system combats cancer more effectively.

Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer, and in PD-L1-positive metastatic triple-negative breast cancer.

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.

To learn more about the Roche approach to cancer immunotherapy please follow this link: View Source