On June 25, 2018 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the Phase III IMpower133 study met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS) at its first interim analysis (Press release, Hoffmann-La Roche, JUN 25, 2018, View Source [SID1234527451]). The study demonstrated that initial (first-line) treatment with the combination of TECENTRIQ (atezolizumab) plus chemotherapy (carboplatin and etoposide) helped people with extensive-stage small cell lung cancer (ES-SCLC) live significantly longer compared to chemotherapy alone. The TECENTRIQ-based combination also reduced the risk of disease worsening or death (PFS) compared to chemotherapy alone. 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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"These are the first positive Phase III survival results for any immunotherapy-based combination in the initial treatment of extensive-stage small cell lung cancer, a particularly difficult-to-treat type of disease," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "The clinically meaningful results from the IMpower133 study add to the growing body of evidence demonstrating that TECENTRIQ-based combinations may be an effective treatment for different types of advanced lung cancer. We look forward to working with health authorities globally to bring this potential treatment option to people with this type of disease as soon as possible."

This is the fourth positive Phase III lung cancer study evaluating a TECENTRIQ-based combination to read out this year and the fifth positive study overall. Currently, Roche has eight Phase III lung cancer studies underway evaluating TECENTRIQ alone or in combination with other medicines across different types of lung cancer.

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 carboplatin and etoposide versus chemotherapy (carboplatin plus etoposide) alone in chemotherapy-naïve people 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 in the intention-to-treat (ITT) population
OS in the ITT population
IMpower133 met its OS and PFS co-primary endpoints as per the study protocol.

About SCLC
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.1 Lung cancer can be broadly divided into two major types: non-small cell lung cancer (NSCLC) and SCLC, with SCLC accounting for approximately 15% of all lung cancer cases.2 Survival rates for people with SCLC vary depending on the stage (extent) of the cancer at the time of diagnosis.3 The five-year relative survival rate for people with stage I SCLC is approximately 31%, however, at stage IV, the five-year relative survival rate declines to approximately 2%.4

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).

On June 24, 2018 ERYTECH Pharma (Euronext:ERYP) (Nasdaq:ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, reported that it will focus its development efforts for its product candidate eryaspase on the potential treatment of selected solid tumor indications (Press release, ERYtech Pharma, JUN 24, 2018, View Source;p=RssLanding&cat=news&id=2355698 [SID1234527450]). The company also announced that it plans to cease its development program for eryaspase in acute lymphoblastic leukemia (ALL), including the withdrawal of its previously submitted MAA for eryaspase for the treatment of relapsed and refractory ALL.

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In 2017, ERYTECH announced positive results from a Phase 2b clinical trial of eryaspase combined with chemotherapy in patients suffering from second-line metastatic pancreatic cancer, as well as the intended launch of a pivotal Phase 3 clinical trial in this indication. Set-up activities are on track and the Phase 3 trial is expected to begin enrollment in the third quarter of 2018. ERYTECH now confirms that it intends to sponsor a Phase 2 proof-of-concept clinical trial of eryaspase later this year in first-line pancreatic cancer, with enrollment expected to commence in the first half of 2019.

In 2018, following the positive results in second-line metastatic pancreatic cancer, ERYTECH also evaluated other potential solid tumor indications and selected metastatic triple-negative breast cancer (TNBC) as the next indication for which to pursue clinical development of eryaspase. ERYTECH is preparing for a Phase 2 proof-of-concept clinical trial in this indication, with the first patient expected to be enrolled in the fourth quarter of 2018. ERYTECH is also evaluating development options in other pancreatic cancer settings and in additional solid tumor indications with high unmet medical need.

In order to ensure adequate supply of eryaspase for its planned clinical trials, as well as the potential commercialization of eryaspase, if approved, the Company is constructing a large-scale manufacturing facility in the United States (Princeton, New Jersey) and is also expanding its manufacturing capacity in Lyon, France. ERYTECH expects both facilities to be operational for clinical production at the expanded capacity in the first quarter of 2019.

Despite having observed favorable efficacy results and safety profile in multiple clinical trials of eryaspase in patients with ALL, ERYTECH now believes, based on recent feedback from the regulatory agencies in Europe and the United States, that significant additional investment would be required in order to seek regulatory approval of eryaspase for the treatment of ALL. In the context of the rapidly changing and increasingly competitive landscape with newly-approved treatment options for ALL, the regulatory requirements and what ERYTECH observes to be a limited market opportunity for eryaspase in ALL, ERYTECH has elected to cease further clinical development efforts in ALL and to withdraw its European MAA. The resources that will become available as a result of this strategic decision will be allocated to what ERYTECH estimates is a significantly larger unmet medical needs and market opportunity for the potential treatment of solid tumors.

ERYTECH’s preclinical development efforts are not affected by this strategic decision. The next product candidate, erymethionase, methionine-g-lyase encapsulated in red blood cells, and the ERYMMUNE (immuno-therapy) research program are also targeting solid tumor indications. ERYTECH intends to initiate a Phase 1 clinical trial of erymethionase later this year, with enrollment expected to commence in the first half of 2019.

Conference Call Details

ERYTECH management will hold a conference call on Monday, June 25, 2018 at 02:30pm CET / 08:30am EDT. Gil Beyen, Chairman and CEO, Eric Soyer, CFO and COO and Iman El-Hariry, CMO will be available for a Q&A session.

On June 23, 2018 Array BioPharma Inc. (NASDAQ: ARRY) reported updated safety and efficacy results, including OS, from the safety lead-in of the Phase 3 BEACON CRC trial evaluating the triplet combination of encorafenib, a BRAF inhibitor, binimetinib, a MEK inhibitor and cetuximab, an anti-EGFR antibody, in patients with BRAFV600E-mutant metastatic colorectal cancer (CRC) (Press release, Array BioPharma, JUN 23, 2018, View Source [SID1234527439]). The results showed that, at the time of analysis, the OS data were fully mature through 12.6 months and that the median OS had not yet been reached. The one-year overall survival rate for this cohort was 62%. These data were presented in an oral presentation on Saturday, June 23, at the ESMO (Free ESMO Whitepaper) 20thWorld Congress on Gastrointestinal Cancer in Barcelona, Spain.

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The median progression-free survival (mPFS) for patients treated with the triplet was 8 months [95% CI 5.6-9.3] and is similar between patients receiving one prior line of therapy and patients receiving two prior lines of therapy. The confirmed overall response rate (ORR) was 48% and among the 17 patients who received only one prior line of therapy the ORR was 62%.

"The results of the BEACON CRC safety lead-in demonstrate substantial improvements in efficacy outcomes when compared to current approved standard of care benchmarks in patients with BRAF-mutant metastatic CRC. The median progression-free survival of 8 months is a meaningful improvement compared to the benchmark of about 2 months, and the overall survival of 62% at 12 months is very promising given that with current approved standards of care, half of patients will succumb to their disease within 4 to 6 months," said Axel Grothey, M.D., Division of Hematology/Oncology, Mayo Clinic. "These data underscore the potential of this triplet combination to benefit patients with BRAFV600E-mutant metastatic CRC, who, despite their poor prognosis, currently have limited effective treatment options."

The triple combination was generally well-tolerated with no unexpected toxicities. The most common grade 3 or 4 adverse events seen in at least 10% of patients were fatigue (13%), anemia (10%), increased blood creatine kinase (10%) and increased aspartate aminotransferase (10%).

The presentation also referenced updated, mature Phase 2 results for the doublet of encorafenib and cetuximab that showed a mOS of 9.3 months, mPFS of 4.2 months and an ORR of 24%. The data cutoff for that analysis was January 2018 with the last patient enrolled in April of 2015; a detailed presentation of these data will occur at a future medical congress.

Enrollment in the randomized portion of the BEACON CRC trial is ongoing. Patients interested in participating in this trial may talk to their doctor to have their tumor tested for the BRAF mutation for eligibility to enroll in this new and important trial. Further details on the trial are available at clinicaltrials.gov (NCT02928224).

A PDF of the ESMO (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer presentation will be available on Array’s website.

Array will host an encore webcast presentation of the BEACON CRC safety lead-in data.

Encore Investor Webcast:

Presenter:

Axel Grothey, M.D., Division of Hematology/Oncology, Mayo Clinic

Date:

Saturday, June 23

Time:

4:30 pm CET (10:30 am ET)

Toll-Free:

(844) 464-3927

Toll:

(765) 507-2598

Pass Code:

8588348

On June 22, 2018 Eidos Therapeutics, Inc. (Nasdaq: EIDX), a clinical stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin (TTR) amyloidosis (ATTR), reported the closing of its initial public offering of 7,187,500 shares of common stock, including the exercise in full of the underwriters’ option to purchase 937,500 additional shares of common stock, at a public offering price of $17.00 per share (Press release, Eidos Therapeutics, JUN 22, 2018, View Source [SID1234576276]). The aggregate gross proceeds to Eidos from the offering were approximately

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$122.2 million, before deducting underwriting discounts and other offering expenses. All of the shares in the offering were offered by Eidos. Eidos’ common stock is listed on The NASDAQ Global Select Market under the ticker symbol "EIDX."

J.P. Morgan Securities LLC and BofA Merrill Lynch acted as joint book-running managers for the offering. Barclays Capital Inc. also participated as a joint book-running manager.

The shares were offered by Eidos pursuant to a registration statement that was declared effective by the Securities and Exchange Commission ("SEC") on June 19, 2018. A prospectus relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov.

This offering was made only by means of a prospectus. Copies of the final prospectus relating to this offering can be obtained from (1) J.P. Morgan Securities LLC, Attention: c/o Broadridge Financial Solutions, Attn: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: (866) 803-9204, or by emailing [email protected]; (2) BofA Merrill Lynch, NC1-004-03-43, 200 North College Street, 3rd Floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by emailing [email protected]; and (3) Barclays Capital Inc., c/o Broadridge Financial Solutions, Attn: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: (888) 603-5847, or by emailing [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, 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 June 22, 2018 Alexo Therapeutics, a clinical-stage immuno-oncology company developing therapies to block the CD47 myeloid checkpoint mechanism, reported the change of the Company’s name to ALX Oncology (Press release, Alexo Therapeutics, JUN 22, 2018, View Source [SID1234527433]). The new name and logo will differentiate ALX Oncology (ALX) from other companies in the field as the Company advances its clinical programs.

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"Our new name further identifies us as an oncology drug developer and distinguishes us from other companies in this sector," said Jaume Pons, Ph.D., ALX Oncology’s President and Chief Executive Officer.

ALX Oncology is developing ALX148, a high affinity CD47 blocker currently in clinical development (NCT03013218). Preliminary results from the Phase 1 trial were recently presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. "Our study results show that ALX148 is generally well tolerated as a single agent and in combination with pembrolizumab, trastuzumab, or rituximab in patients with advanced solid tumors and non-Hodgkin lymphoma," said Sophia Randolph, M.D., Ph.D., ALX Oncology’s Chief Medical Officer. "We look forward to reporting the results of ALX148 combinations in expanded patient populations at upcoming conferences."

About ALX148
ALX148 is a fusion protein comprised of an engineered high affinity CD47 binding domain of SIRPα linked to an inactive Fc region of human immunoglobulin. ALX148 potently and specifically binds CD47 and blocks its interaction with SIRPα, thus inhibiting a key myeloid immune checkpoint mechanism exploited by cancer cells. In preclinical studies, ALX148 bridges innate and adaptive immunity to enhance anti-tumor response in combination with targeted anti-cancer antibodies and checkpoint inhibitors with no adverse effect on CD47-expressing normal blood cells. ALX148 is currently being investigated in a Phase 1 study in combination with checkpoint inhibitors and targeted anti-cancer antibodies (NCT03013218).