On May 14, 2020 The Janssen Pharmaceutical Companies of Johnson & Johnson reported results from the final analysis of the pivotal Phase 3 SPARTAN study demonstrating ERLEADA▼ (apalutamide) in combination with androgen deprivation therapy (ADT) significantly improved overall survival (OS), compared to ADT alone, in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who were at high risk of developing metastases.1 Results will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Programme (Abstract #5516) beginning on Friday 29th May.1 (Press release, Janssen Pharmaceuticals, MAY 14, 2020, View Source [SID1234558161])

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Findings from the study showed that apalutamide in combination with ADT prolonged median overall survival by 14 months and decreased the risk of death by 22 percent.1 Median OS was significantly longer, with 73.9 months for patients receiving treatment with apalutamide in combination with ADT compared to 59.9 months with patients receiving placebo in combination with ADT [HR=0.78; p=0.0161 (to reach statistical significance, a p-value of p<0.046 needed to be observed)].1 After the study met its primary endpoint of metastasis-free survival (MFS), the SPARTAN study was unblinded and patients on placebo were allowed to crossover to apalutamide. The OS results were achieved despite a crossover of 76 randomised placebo patients (19 percent) to apalutamide treatment.1 After adjusting for the cross-over of patients in the placebo arm, the treatment effect of apalutamide plus ADT exceeded median OS compared to placebo plus ADT with a difference of 21 months between the two arms (73.9 months vs 52.8 months, respectively, HR=0.69, p=0.0002). Additionally, treatment with apalutamide in combination with ADT significantly delayed patients’ time to cytotoxic chemotherapy compared to placebo in combination with ADT (HR=0.63; p=0.0002).1

"Treatment for patients with non-metastatic castration-resistant prostate cancer is primarily focused on delay of metastases and improvement of overall survival," said Eric Small, M.D., FASCO, Professor of Medicine, and Chief Scientific Officer at the Helen Diller Family Comprehensive Cancer Center at the University of California, San Francisco, and lead SPARTAN study investigator. "The final analysis of SPARTAN includes long-term data for each of these treatment parameters and helps to support the earlier use of apalutamide versus ADT alone."

Together with data from the primary analysis, the SPARTAN study has met all primary, secondary and exploratory endpoints. The primary endpoint of the study was MFS; the secondary endpoints were time to metastasis, progression-free survival (PFS), time to symptomatic progression, OS and time to initiation of cytotoxic chemotherapy; and the exploratory endpoints were second progression-free survival (PFS2), PSA responses and risk of PSA progression.1,2

"Our driving commitment to delay the onset of metastases and add years to life for prostate cancer patients has taken a significant step forward with today’s data," said Dr Joaquín Casariego, M.D., Janssen Therapeutic Area Lead Oncology for Europe, Middle East & Africa, Janssen-Cilag S.A. "The SPARTAN trial has successfully demonstrated that apalutamide improved overall survival by an average of 14 months, reinforcing the need to treat earlier in prostate cancer for the benefit of patients and their families. At Janssen, our vision is to pioneer new approaches to treating cancer by thinking differently about diagnosis and looking towards intercepting the disease before it can even take a hold."

Median treatment duration was nearly three times longer for patients treated with apalutamide plus ADT (33 months) compared with those treated with placebo plus ADT (12 months).1 Grade 3/4 treatment-emergent adverse events of special interest were rash (5.2 percent), fractures (4.9 percent), falls (2.7 percent), ischemic heart disease (2.6 percent), hypothyroidism (0 percent) and seizures (0 percent). Safety and tolerability of apalutamide is consistent and as reported previously.1,3

Initial results from the SPARTAN trial were presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU) and simultaneously published in The New England Journal of Medicine.2,4 The study met its primary endpoint of MFS demonstrating a median MFS of more than two years (difference of 24.31 months) and a 72 percent reduction in risk of distant metastasis in patients with nmCRPC.4 OS data were not mature at the time of the final MFS analysis (24 percent of the required number of events). Updated results were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress in 2019 and were simultaneously published in Annals of Oncology.5,6

#ENDS#

About the SPARTAN Study
SPARTAN (NCT01946204) is a Phase 3, randomised, registrational, double-blind, placebo-controlled, multicentre study that evaluated ERLEADA (apalutamide) in combination with ADT in men with nmCRPC with a rapidly rising PSA (PSA Doubling Time ≤10 months).2,7 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

About Non-Metastatic Castration-Resistant Prostate Cancer
Non-metastatic castration-resistant prostate cancer (nmCRPC) refers to a disease stage in which 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/or CT/MRI scan.8 Features include: lack of detectable metastatic disease using conventional radiographic imaging and rapidly rising PSA while on ADT with serum testosterone level below 50 ng/dL.9,10 Ninety percent of patients with nmCRPC will eventually develop metastases, which can lead to pain, fractures and other symptoms.11 The relative five-year survival rate for patients diagnosed with a distant-stage prostate cancer is 31 percent.12 It is critical to delay the development of metastasis in patients with nmCRPC.

About ERLEADA
ERLEADA (apalutamide) is an androgen receptor (AR) inhibitor indicated for use in Europe for the treatment of adult men with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease and in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).7 In the U.S. apalutamide is indicated for the treatment of nmCRPC and mHSPC.13

Warnings and Precautions include ischemic heart disease, fractures, falls and seizure.2,3 In the SPARTAN study, the most common adverse reactions (≥10 percent) were fatigue, hypertension, rash, diarrhoea, nausea, weight decreased, arthralgia, falls, hot flush, decreased appetite, fracture and peripheral edema.1,4

On May 14, 2020 ADC Therapeutics SA, a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates for patients suffering from hematological malignancies and solid tumors, reported the pricing of the initial public offering of 12,245,631 shares of its common shares at a price of $19.00 per share (Press release, ADC Therapeutics, MAY 14, 2020, View Source [SID1234558148]). The gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses payable by ADC Therapeutics, are expected to be approximately $232.7 million. The shares are expected to begin trading on the New York Stock Exchange on May 15, 2020 under the ticker symbol "ADCT." The offering is expected to close on May 19, 2020, subject to customary closing conditions. In addition, ADC Therapeutics has granted the underwriters a 30-day option to purchase up to 1,836,844 additional common shares.

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Morgan Stanley, BofA Securities and Cowen are acting as joint book-running managers for the offering.

The offering is being made only by means of a prospectus. Copies of the prospectus relating to the offering may be obtained, when available, from Morgan Stanley & Co. LLC, Attn: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, by telephone at (866) 718-1649 or by email at [email protected]; BofA Securities, Inc., NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attn: Prospectus Department, or by email at [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attn: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (833) 297-2926 or by email at [email protected].

A registration statement relating to these securities has been filed with, and declared effective by, the U.S. Securities and Exchange Commission. 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 jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. There is no intention or permission to publicly offer, solicit, sell or advertise, directly or indirectly, any securities of ADC Therapeutics SA, such as the common shares, in or into Switzerland within the meaning of the Swiss Financial Services Act ("FinSA") and these securities will not be listed or admitted to trading on the SIX Swiss Exchange or on any other regulated trading venue (exchange or multilateral trading facility) in Switzerland. Neither this document nor any other offering or marketing material relating to these securities, such as the common shares, constitutes or will constitute a prospectus pursuant to the FinSA, and neither this document nor any other offering or marketing material relating to the common shares constitutes a prospectus pursuant to the FinSA, and neither this document nor any other offering or marketing material relating to the common shares may be publicly distributed or otherwise made publicly available in Switzerland.

On May 14, 2020 Pulse Biosciences, Inc. (Nasdaq: PLSE) (the "Company" or "Pulse Biosciences"), a novel bioelectric medicine company, reported that it has commenced its previously-announced rights offering of up to 4,279,600 of units (the "Units," and each, a "Unit") at the Initial Price (as defined below) with an aggregate offering value of up to $30,000,000 (Press release, Pulse Biosciences, MAY 14, 2020, View Source [SID1234558109]). The subscription rights will expire and have no value if they are not exercised prior to 5:00 p.m. Eastern Time on June 8, 2020 (the "Expiration Date").

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Pursuant to the rights offering, Pulse Biosciences is distributing, at no charge to the holders of its common stock, non-transferable subscription rights to purchase the Units. Each Unit shall consist of one share of the Company’s common stock, par value $0.001 per share, and 0.15 warrants to purchase shares of common stock. The subscription price per Unit shall be equal to the lesser of (i) $7.01 per Unit (the "Initial Price") or (ii) the volume weighted average price of the Company’s common stock for the five trading day period through and including the Expiration Date (the "Alternate Price"). The subscription price will determine the final number of Units issuable, and subsequently the pro rata number of Units to which stockholders can subscribe. Each warrant will be exercisable for one share of the Company’s common stock at an exercise price that shall be equal to the subscription price for the Units.

Stockholders wishing to exercise subscription rights must timely pay $7.01 per Unit, the Initial Price, for the number of Units they wish to acquire. If the Alternate Price is lower than the Initial Price on the Expiration Date, any excess subscription amounts paid by a subscribing holder will be applied towards the purchase of additional Units in the rights offering. Stockholders who fully exercise their basic subscription rights will be entitled to subscribe for additional Units that are not purchased by other stockholders, on a pro rata basis and subject to availability.

A registration statement, as amended, relating to the Units was previously filed with the Securities and Exchange Commission (the "SEC") and declared effective on May 8, 2020. A prospectus relating to the offering was filed with the SEC on May 14, 2020 and is available on the SEC’s website. Questions about the rights offering and requests for copies of the prospectus relating to the rights offering may be directed to Broadridge Corporate Issuer Solutions, Inc., the Company’s information, subscription and warrant agent for the rights offering, at the address and phone number provided at the end of this release.

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 registration or qualification under the securities laws of any such state or other jurisdiction. Any offer will be made only by means of the prospectus forming a part of the effective registration statement.

On May 14, 2020 Moffitt Cancer Ctr reported that Chimeric antigen receptor T-cell therapy, or CAR T, has become a game changer for lymphoma and leukemia patients who have relapsed or become resistant to previous treatments (Press release, Moffitt Cancer Ctr, MAY 14, 2020, View Source [SID1234558108]). The therapy uses a patient’s own immune cells that are re-engineered in the lab to seek out and kill cancer cells when infused back into the patient. Yescarta (axicabtagene ciloleucel) was the first CAR T-cell therapy approved for the treatment of adults with large B cell lymphoma. The pivotal ZUMA-1 clinical trial that led to its approval showed that 83% of patients responded to the therapy, with 58% having a complete response. But clinical trials often have stringent eligibility criteria and the outcomes observed may not match what physicians see in a real-world clinical setting.

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Moffitt Cancer Center organized a consortium of 16 cancer treatment facilities across the U.S. that offer Yescarta as a standard-of-care therapy for patients with relapsed/refractory large B cell lymphoma. They wanted to determine if the safety and effectiveness seen in the ZUMA-1 clinical trial were similar for patients treated with the now commercially available CAR T therapy. Their findings were published in the Journal of Clinical Oncology.

The consortium pooled retrospective data on 298 patients who completed apheresis, the process to remove a patient’s T cells, with the intent of having Yescarta manufactured and administered. It is important to point out that of this group, 129 patients (43%) would not have qualified for CAR T-cell therapy based on the ZUMA-1 comorbidity eligibility criteria. Overall, 275 patients (92%) received a Yescarta infusion. In the ZUMA-1 trial, 108 patients received Yescarta.

"Our analysis found that the overall response rate of 82%, and estimated 12 month durable response rate of 47%, for our group of patients compared favorably to the ZUMA-1 trial results," said Frederick Locke, M.D., corresponding author of the study and vice chair of the Department of Blood and Marrow Transplant and Cellular Immunotherapy and co-leader of the Immunology Program at Moffitt. "Durable response rates were encouraging even in patients with significant comorbidities, suggesting that patients need not meet ZUMA-1 eligibility criteria to benefit from axicabtagene ciloleucel."

One adverse reaction that can occur following CAR T therapy is cytokine release syndrome (CRS). This occurs when a large number of cytokines, which are small proteins released by immune cells, are rapidly released into the blood. This can cause a patient to have a fever, increased heart rate, difficulty breathing and low blood pressure. In the ZUMA-1 trial, 11% of patients treated with Yescarta experienced severe CRS. However, in the commercial setting, that number was lower at 7%.

"We believe this observation is due to the greater use of tocilizumab and corticosteroids compared to ZUMA-1, in line with evolving practice patterns for toxicity management," said Michael Jain, M.D., Ph.D., co-first author and assistant member of the Blood and Marrow Transplant and Cellular Immunotherapy Department at Moffitt.

The authors believe this study suggests that patients do not need to meet the ZUMA-1 eligibility criteria to benefit from Yescarta, including upper age limits and those with underlying conditions.

This study was funded by the National Cancer Institute through grants to Locke (K23CA201594) and Moffitt (P30CA076292).

On May 14, 2020 Targovax ASA (OSE: TRVX), a clinical stage immuno-oncology company developing oncolytic viruses to target hard-to-treat solid tumors, reported that an abstract relating to the dose escalation part of the ONCOS-102 and durvalumab trial in primary ovarian and colorectal cancer that has spread to the peritoneum has been selected for presentation at a Poster Discussion Session during ASCO (Free ASCO Whitepaper) 2020 (Press release, Targovax, MAY 14, 2020, View Source [SID1234558099]).

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The study is an open label, exploratory phase I/II trial assessing the intra-peritoneally delivered ONCOS-102 in combination with systemically administered checkpoint inhibitor durvalumab in patients with platinum-resistant ovarian or colorectal cancers that have metastasized to the peritoneal cavity. The trial is designed with a dose-escalation phase assessing three different dosing levels, followed by an expansion phase with a total of up to 78 patients enrolled into separate groups of ovarian and colorectal cancer.

In the ASCO (Free ASCO Whitepaper) abstract, safety, immune activation and clinical response data for the three dose escalation cohorts will be presented. A total of 17 patients were enrolled, 4 in cohort A (low dose), 5 in cohort B (middle dose) and 8 in cohort C (high dose). No dose-limiting toxicities were observed, and the combination had an acceptable safety profile. Therefore, the high-dose level was selected for the expansion phase of the trial, which is currently enrolling patients. Preliminary analyses indicate that the treatment is triggering immune activation and has clinical activity, which were more pronounced in cohort B and C.

Dr. Magnus Jäderberg, Chief Medical Officer of Targovax, said: "We are very proud that ONCOS-102 was chosen as the oncolytic virus of choice for this trial and we are equally pleased that the scientific committee has selected our ONCOS-102 and durvalumab combination abstract for a poster discussion at the upcoming ASCO (Free ASCO Whitepaper) meeting. Although it is too early in the trial to interpret the clinical data, we are happy to have moved into the expansion phase following successful completion of the dose escalation phase. This is an important clinical trial as it addresses a disease with a very high unmet medical need while potentially opening up intra-peritoneal administration as an alternative delivery route for ONCOS-102."

Poster discussion sessionAbstract title:

Developmental Therapeutics-ImmunotherapyPhase I/II study to evaluate systemic durvalumab + intraperitoneal (IP) ONCOS-102 in patients with peritoneal disease who have epithelial ovarian (OC) or metastatic colorectal cancer (CRC): Interim phase I clinical and translational results.

Date / time:

29 May 2020, 8-11AM CDT

Abstract / Poster:

3017 / 81

The abstract can be found here View Source

The trial is a collaboration between Targovax, AstraZeneca, Cancer Research Institute (CRI) and Ludwig Cancer Research.