On July 26, 2019 IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology company, reported that company management will be presenting at the Canaccord Genuity 39th Annual Growth Conference on Thursday, August 8, 2019 at 3:30 p.m. ET in Boston, MA (Press release, IMV, JUL 26, 2019, View Source [SID1234537791]).

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!

A live webcast of the presentation will be available under "Events, Webcasts and Presentations" in the Investors section of IMV’s website. The webcast will be available for replay approximately one hour after the presentation and will be archived for 90 days.

On July 26, 2019 Servier and its partner Taiho Pharmaceutical Co., Ltd reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for LONSURF (trifluridine/tipiracil) as monotherapy for the treatment of adult patients with metastatic gastric cancer including adenocarcinoma of the gastroesophageal junction, who have been previously treated with at least two prior systemic treatment regimens for advanced disease (Press release, Servier, JUL 26, 2019, View Source [SID1234537790]). The CHMP’s opinion will now be sent to the European Commission (EC) for the adoption of the decision.

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!

Gastric cancer in Europe affects approximately 130,000 people a year,1 and it is estimated that 40% of those patients will have metastatic disease.2 For those with advanced or metastatic disease the treatment options are limited and are often palliative.

"The positive opinion from the CHMP for LONSURF is very welcomed; patients with metastatic gastric cancer have few therapeutic options remaining, so it is of the upmost importance new therapies are made available. The Phase III trial TAGS demonstrated that LONSURF was effective and tolerable for these patients and gave patients valuable months of life," said Professor Josep Tabernero, Head of the Medical Oncology Department, Vall d’Hebron University Hospital, Barcelona and Director of the Vall d’Hebron Institute of Oncology (VHIO).

The marketing authorization application was supported by data from the global Phase III trial TAGS (TAS-102 Gastric Study) which was a randomized, double-blind study evaluating LONSURF, plus best supportive care (BSC) versus placebo plus BSC in patients with metastatic gastric cancer refractory to standard treatments. LONSURF demonstrated significant improvement in overall survival (OS) (HR=0.69 [95% CI 0.56-0.85], p=0.00029) compared to placebo plus BSC. The median OS in patients treated with LONSURF and BSC was 5.7 months compared to 3.6 months when treated with placebo and BSC, and there was a 31% risk reduction of death. The overall safety profile was consistent with the known safety profile of LONSURF in metastatic colorectal cancer (CRC), with mainly hematological adverse events reported.

"Today’s announcement is one step closer to ensuring patients with metastatic gastric cancer have another treatment option, bringing an incremental survival benefit over the standard of care," said Patrick Therasse, Head of Servier Research and Development Oncology. "Gastric cancer is difficult to treat and each step forward is a major event."

Currently in the EU, LONSURF is indicated for the treatment of adult patients with metastatic colorectal cancer who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents.3

#ENDS#

About Metastatic Gastric Cancer

Gastric cancer, also known as stomach cancer, is a disease in which malignant cells form in the lining of the stomach. It is the fifth most common cancer worldwide and the third most common cause of cancer-related death (after lung and colorectal cancer), with an estimated 780,000 deaths annually.4　

When cancer spreads it is called advanced cancer. Locally advanced cancer is when the cancer has grown outside the organ it started in but hasn’t spread to other parts of the body. When the cancer spreads to other parts of the body, this is called metastatic cancer. In the last two decades, the proportion of patients with gastric cancer who present with metastases has risen to over 40%.2

Standard chemotherapy regimens for advanced gastric cancer include fluoropyrimidines, platinum derivatives, and taxanes (with ramucirumab), or irinotecan. The addition of trastuzumab to chemotherapy is standard of care for patients with HER2/neu-positive advanced gastric cancer. However, after failure of first- and second-line therapies, there are neither approved nor standard third-line treatments in the EU.

About LONSURF3

LONSURF consists of a thymidine-based nucleoside analog, trifluridine, and the thymidine phosphorylase (TP) inhibitor, tipiracil, which increases trifluridine exposure by inhibiting its metabolism by TP. Trifluridine is incorporated into DNA, resulting in DNA dysfunction and inhibition of cell proliferation.

In the EU, LONSURF is indicated for the treatment of adult patients with metastatic colorectal cancer (CRC) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents.

As of July 2019, LONSURF has been approved as a treatment for advanced mCRC in 68 countries and regions. In February 2019, LONSURF has been approved as a treatment for mGC/mGEJC in the United States.

LONSURF was discovered and developed by Taiho Pharmaceutical. In June 2015, Taiho Pharmaceutical and Servier entered into an exclusive license agreement for the co-development and commercialization of LONSURF in Europe and other countries outside of the United States, Canada, Mexico and Asia.

On July 26, 2019 Seattle Genetics, Inc. (Nasdaq: SGEN) reported the completion of its previously announced underwritten public offering of 8,214,286 shares of its common stock at a price to the public of $70.00 per share, including 1,071,428 shares sold pursuant to the exercise in full of the underwriters’ overallotment option to purchase additional shares (Press release, Seattle Genetics, JUL 26, 2019, View Source [SID1234537789]). All of the shares were sold by Seattle Genetics. Including the option exercise, the aggregate gross proceeds to Seattle Genetics from the offering, before deducting the underwriting discounts and commissions and offering expenses, were approximately $575 million.

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!

Seattle Genetics anticipates using the net proceeds from the offering to fund ongoing commercialization of ADCETRIS in the United States and Canada, to fund its activities in preparation for the potential commercial launch of enfortumab vedotin, if approved by the FDA, to fund its research and development efforts designed to further expand the ADCETRIS label and to advance its pipeline of product candidates, as well as for general corporate purposes, including working capital. Seattle Genetics may also use a portion of the net proceeds to in-license, acquire or invest in complementary products, technologies, businesses or other assets or pursue other strategic opportunities although at this time Seattle Genetics has no material agreements or commitments with respect to any new in-license or acquisition opportunity.

J.P. Morgan Securities LLC, SVB Leerink LLC and Goldman Sachs & Co. LLC acted as joint book-running managers for the offering. Barclays Capital Inc., RBC Capital Markets, LLC and Guggenheim Securities, LLC acted as co-managers for the offering.

A shelf registration statement relating to the shares was previously filed with and became effective by rule of the Securities and Exchange Commission. The offering was made solely by means of a prospectus. A final prospectus supplement and accompanying prospectus relating to the offering has been filed with the Securities and Exchange Commission and is available on the Securities and Exchange Commission’s website located at View Source A copy of the final prospectus supplement and accompanying prospectus relating to the offering may be obtained from: J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (866) 803-9204 or by email at [email protected]; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132, or by email at [email protected]; or Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526, by facsimile at (212) 902-9316 or by email at [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 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.

On July 26, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that it will report its second quarter 2019 financial results on Thursday, August 1, 2019 (Press release, Iovance Biotherapeutics, JUL 26, 2019, View Source [SID1234537788]). Management will host a conference call to discuss these results and provide a corporate update at 4:30 p.m. EDT.

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!

To participate in the conference call, please dial 1-844-646-4465 (domestic) or 1-615-247-0257 (international) and reference the access code 7574927. A live and archived webcast of the call can be accessed in the Investors section of the Company’s website at www.iovance.com or at the link: View Source

On July 26, 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Tecentriq (atezolizumab) in combination with chemotherapy (carboplatin and etoposide) for the initial (first-line) treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) (Press release, Hoffmann-La Roche, JUL 26, 2019, View Source [SID1234537786]). This decision is based on results from the Phase III IMpower133 study, which showed that Tecentriq in combination with chemotherapy helped people live significantly longer compared with chemotherapy alone (median overall survival [OS]=12.3 vs. 10.3 months; hazard ratio [HR]=0.70, 95% CI: 0.54–0.91; p=0.0069) in the intention-to-treat (ITT) population.1 The Tecentriq-based combination also significantly reduced the risk of disease worsening or death (progression-free survival, PFS) compared with chemotherapy alone (PFS=5.2 versus 4.3 months; HR=0.77, 95% CI: 0.62–0.96; p=0.017).

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!

This is the first Phase III study to show that a cancer immunotherapy-based combination significantly improved OS and PFS in the first-line treatment of ES-SCLC. Safety for the Tecentriq and chemotherapy combination appeared consistent with the known safety profile of Tecentriq.

"We are pleased to receive a positive opinion from the CHMP for our Tecentriq-based lung cancer combination for people living with extensive-stage small cell lung cancer," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "The combination of Tecentriq and chemotherapy has the potential to address the high unmet need in this aggressive form of lung cancer where advances in survival have been very difficult to achieve."

Lung cancer is the leading cause of cancer death worldwide2 and SCLC accounts for approximately 15% of all lung cancer cases, with the majority of patients (70%) diagnosed in the "extensive stage", often meaning a poor prognosis.3 SCLC is distinguished from other lung cancer subtypes due to its aggressive nature, rapid growth and early development of metastatic disease.3

If the European Commission (EC) follows the EMA CHMP’s recommendation, this Tecentriq-based combination could represent a potential new treatment option for people across Europe with ES-SCLC. Based on the CHMP positive opinion, a final decision regarding the approval of this Tecentriq-based combination is expected from the EC in the near future.

About the IMpower133 study
IMpower133 is a Phase III, multicentre, double-blinded, randomised placebo-controlled study evaluating the efficacy and safety of Tecentriq in combination with chemotherapy (carboplatin and etoposide) vs. chemotherapy (carboplatin and etoposide) alone in chemotherapy-naïve adults with ES-SCLC.

The study enrolled 403 people who were randomised equally (1:1) to receive:

Tecentriq in combination with carboplatin and etoposide (Arm A), or
Placebo in combination with carboplatin and etoposide (Arm B, control arm)
During the treatment-induction phase, people received treatment on 21-day cycles for four cycles, followed by maintenance with Tecentriq or placebo until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1). Treatment could be continued until persistent radiographic PD or symptomatic deterioration was observed.

The co-primary endpoints were PFS as determined by the investigator using RECIST v1.1 and OS in the ITT population.

A summary of the ITT data from the IMpower133 study that support this recommendation is included below:1

Tecentriq in combination with chemotherapy helped people live significantly longer, compared with chemotherapy alone (OS=12.3 vs. 10.3 months; HR=0.70, 95% CI: 0.54-0.91; p=0.0069) in the ITT population.
The Tecentriq-based combination also significantly reduced the risk of disease worsening or death compared to chemotherapy alone (PFS=5.2 vs. 4.3 months; HR=0.77; 95% CI: 0.62-0.96; p=0.017).
Safety for the Tecentriq and chemotherapy combination appeared consistent with the known safety profile of Tecentriq.
Serious adverse reactions occurred in 56.6% of people receiving Tecentriq plus chemotherapy compared to 56.1% of people receiving chemotherapy alone. The most common adverse reactions (≥20%) in people receiving Tecentriq plus chemotherapy were low white blood cell count (neutropenia; 23%), anaemia (14%), decreased neutrophil count (14%) and thrombocytopenia (10%).
About SCLC
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 SCLC, with SCLC accounting for approximately 15% of all lung cancer cases.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 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