On May 3, 2019 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported that the U.S. Food and Drug Administration (FDA) has approved Kadcyla (ado-trastuzumab emtansine) for adjuvant (after surgery) treatment of people with HER2-positive early breast cancer (EBC) who have residual invasive disease after neoadjuvant (before surgery) taxane and Herceptin (trastuzumab)-based treatment (Press release, Genentech, MAY 3, 2019, View Source [SID1234535706]).

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"This approval is a significant treatment advance for HER2-positive early breast cancer. By working closely with the FDA and participating in the Real-Time Oncology Review pilot program, we are able to make Kadcyla available for people with residual invasive disease after neoadjuvant therapy much sooner than anticipated," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "With every step forward in reducing the risk of disease recurrence, we come closer to the goal of helping each person with early breast cancer have the greatest opportunity for cure."

The goal in treating EBC is to provide people with the best chance for a cure, which may involve treatment before and after surgery as part of a comprehensive treatment approach. While we come closer to this goal with each advance, many people still have a disease recurrence in the long term. Neoadjuvant treatment is given before surgery with the goal of shrinking tumors and helping to improve surgical outcomes. Adjuvant treatment is given after surgery and aims to eliminate any remaining cancer cells in the body to help reduce the risk of the cancer returning.

The FDA rapidly reviewed and approved the application under the FDA’s Real-Time Oncology Review (RTOR) and Assessment Aid pilot programs, leading to an approval 12 weeks after completing the submission. Kadcyla is the first Genentech medicine approved under the RTOR pilot program, which is exploring a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. For this indication, Kadcyla was also granted Breakthrough Therapy Designation, which is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases.

This approval is based on results of the Phase III KATHERINE study showing Kadcyla significantly reduced the risk of invasive breast cancer recurrence or death from any cause (invasive disease-free survival; iDFS) by 50% (HR=0.50, 95% CI 0.39-0.64, p<0.0001) compared to Herceptin as an adjuvant treatment in people with HER2-positive EBC who have residual invasive disease after neoadjuvant taxane and Herceptin-based treatment. At three years, 88.3% of people treated with Kadcyla did not have their breast cancer return compared to 77.0% treated with Herceptin, an absolute improvement of 11.3%. People who have residual disease after neoadjuvant treatment have a worse prognosis than those with no detectable disease.

The most common Grade 3 or higher side effects (>2%) with Kadcyla in the KATHERINE study were decreased platelet count and high blood pressure. The most common side effects (>25%) with Kadcyla were fatigue; nausea; increased blood levels of liver enzymes; musculoskeletal pain; bleeding; decreased platelet count; headache; numbness, tingling or pain in the hands or feet; and joint pain.

For those who qualify, Genentech offers patient assistance programs for people prescribed Kadcyla by their doctor. Please contact Genentech Access Solutions at (866) 422-2377 or visit View Source for more information.

About the KATHERINE study

KATHERINE is an international, multi-center, two-arm, randomized, open-label, Phase III study evaluating the efficacy and safety of Kadcyla versus Herceptin as an adjuvant therapy in people with HER2-positive EBC who have pathological invasive residual disease in the breast and/or axillary lymph nodes following neoadjuvant therapy that included Herceptin and taxane-based chemotherapy. The primary endpoint of the study is iDFS, which in this study is defined as the time from randomization free from invasive breast cancer recurrence or death from any cause. Secondary endpoints include iDFS including second primary non-breast cancer, disease-free survival and overall survival.

KATHERINE Study Results

Kadcyla
n=743

Herceptin
n=743

Median follow-up 40 months
Invasive disease-free survival (iDFS)
Risk reduction HR=0.50, 95% CI 0.39-0.64, p<0.0001
3-year iDFS 88.3% 77.0%
11.3% absolute improvement
Adverse reactions (ARs)
Grade ≥3 AR 26% 15%
Most common Grade ≥3 ARs (>2%)
Thrombocytopenia (decreased platelet count) 6% 0.3%
Hypertension (high blood pressure) 2.0% 1.2%

About HER2-positive breast cancer

Breast cancer is one of the most common cancers among women worldwide. According to the American Cancer Society, approximately 271,000 people in the United States will be diagnosed with breast cancer, and more than 42,000 will die from the disease in 2019. Breast cancer is not one, but many diseases based on the biology of each tumor. In HER2-positive breast cancer, there is excess HER2 protein on the surface of tumor cells. Approximately 15-20% of breast cancers are HER2-positive based on the result of a diagnostic test.

About Kadcyla

Kadcyla is an antibody-drug conjugate (ADC) engineered to deliver potent chemotherapy directly to HER2-positive cancer cells. It is designed to limit damage to healthy tissues, although it can still affect them. Kadcyla can cause serious side effects. It combines two anti-cancer agents using a stable linker: the HER2-targeting trastuzumab (the active ingredient in Herceptin) and the chemotherapy agent DM1. Kadcyla is the only ADC approved for the treatment of HER2-positive early and metastatic breast cancer. In the U.S., Genentech licenses technology for Kadcyla under an agreement with ImmunoGen, Inc.

Kadcyla Indication Statements

Kadcyla is approved as an adjuvant (after surgery) treatment for HER2-positive early breast cancer when the patient has taken neoadjuvant (before surgery) treatment including a taxane and trastuzumab (Herceptin) and there is cancer remaining in the tissue removed during surgery. Patients are selected for therapy based on an FDA-approved test for Kadcyla.

Kadcyla is approved to treat HER2-positive breast cancer that has spread to other parts of the body (metastatic breast cancer) after prior treatment with trastuzumab (Herceptin) and a taxane. Prior treatment could have been for the initial treatment of breast cancer or for the treatment of cancer that had spread to other parts of the body. Patients are selected for therapy based on an FDA-approved test for Kadcyla.

Important Safety Information

Most important safety information about Kadcyla

Liver problems

Kadcyla may cause severe liver problems that can be life-threatening. Symptoms of liver problems may include vomiting, nausea, eating disorder (anorexia), yellowing of the skin (jaundice), stomach pain, dark urine, or itching.
Heart problems

Kadcyla may cause heart problems, including those without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure). Symptoms may include swelling of the ankles or legs, shortness of breath, cough, rapid weight gain of more than five pounds in 24 hours, dizziness or loss of consciousness, or irregular heartbeat.
Pregnancy

Receiving Kadcyla during pregnancy can result in the death of an unborn baby and birth defects. Birth control should be used while receiving Kadcyla and for seven months after a patient’s last dose of Kadcyla.
If a patient thinks she may be pregnant, she should contact her healthcare provider immediately.
If a patient is exposed to Kadcyla during pregnancy or becomes pregnant within seven months following her last dose of Kadcyla, she is encouraged to report Kadcyla exposure to Genentech by calling (888) 835-2555.
If a male patient has a female partner that could become pregnant, birth control should be used during treatment and for four months following his last dose of Kadcyla.
A patient should not breastfeed during treatment and for seven months after the last dose of Kadcyla.
A patient should contact their doctor right away if they experience symptoms associated with these side effects.

Additional possible serious side effects of Kadcyla

Lung problems

Kadcyla may cause lung problems, including inflammation of the lung tissue, which can be life-threatening. Signs of lung problems may include trouble breathing, cough, tiredness, and fluid in the lungs.
Infusion-related reactions

Symptoms of an infusion-related reaction may include one or more of the following: the skin getting hot or red (flushing), chills, fever, trouble breathing, low blood pressure, wheezing, tightening of the muscles in the chest around the airways, or a fast heartbeat. A patient’s doctor will monitor the patient for infusion-related reactions.
Serious bleeding

Kadcyla can cause life-threatening bleeding. Taking Kadcyla with other medications used to thin the blood (antiplatelet) or prevent blood clots (anticoagulation) can increase the risk of bleeding. A patient’s doctor should provide additional monitoring if the patient is taking one of these other drugs while on Kadcyla. Even when blood thinners are not also being taken, life-threatening bleeding may occur with Kadcyla.
Low platelet count

Low platelet count may happen during treatment with Kadcyla. Platelets help the blood to clot. Signs of low platelets may include easy bruising, bleeding, and prolonged bleeding from cuts. In mild cases there may not be any symptoms.
Nerve damage

Symptoms may include numbness and tingling, burning or sharp pain, sensitivity to touch, lack of coordination, muscle weakness, or loss of muscle function.
Skin reactions around the infusion site

Kadcyla may leak from the vein or needle and cause reactions such as redness, tenderness, skin irritation, or pain or swelling at the infusion site. If this happens, it is more likely to happen within 24 hours of the infusion.
Most common side effects of Kadcyla

The most common side effects in people taking Kadcyla for early breast cancer are:

Tiredness
Nausea
Liver problems
Pain that affects the bones, muscles, ligaments and tendons
Bleeding
Low platelet count
Headache
Weakness, numbness, and pain in the hands and feet
Joint pain
The most common side effects seen in people taking Kadcyla for metastatic breast cancer are:

Tiredness
Nausea
Pain that affects the bones, muscles, ligaments and tendons
Bleeding
Low platelet count
Headache
Liver problems
Constipation
Nosebleeds
Patients are encouraged to report side effects to Genentech and the FDA. Patients may contact Genentech by calling (888) 835-2555. Patients may contact the FDA by visiting View Source or calling (800) FDA-1088.

Please click here for Kadcyla full Prescribing Information, including Most Important Safety Information, for additional Important Safety Information.

About Genentech in breast cancer

Genentech has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have substantially improved outcomes for HER2-positive breast cancer. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for other subtypes of the disease, including triple-negative and hormone receptor-positive.

On May 3, 2019 IMV Inc. (Nasdaq: IMV; TSX: IMV), the clinical stage immuno-oncology corporation, reported that the 2019 International Conference on Malignant Lymphoma (ICML) will publish an abstract on the company’s combination immunotherapy trial titled, "Phase 2 Study: DPX-Survivac with Intermittent Low Dose Cyclophosphamide and Pembrolizumab in Patients with recurrent/refractory Diffuse Large B-Cell Lymphoma – The SPiReL trial (Press release, IMV, MAY 3, 2019, View Source [SID1234535705])."

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"DLBCL is our first indication for DPX-Survivac in combination with Merck’s’ Keytruda (pembrolizumab) and we have been encouraged by the previously announced early data in this patient population with rapidly progressing cancer and short life expectancy," said Frederic Ors, Chief Executive Officer at IMV. "Given the high level of unmet need in recurrent/refractory DLBCL, we look forward to working with our partners at Sunnybrook Research Institute to provide an update on this important program."

ICML will publish the full trial-in-progress abstract on June 12, 2019 via the 15-ICML ABSTRACT BOOK, a supplement to Hematological Oncology. IMV will provide an update on the Phase 2 clinical data related to this study at that time.

About the SPiReL Study

SPiReL (DPX-Survivac with Low Dose Cyclophosphamide administered with Pembrolizumab in Patients with persistent or Recurrent/refractory Diffuse Large B-Cell Lymphoma) is a Phase 2 non-randomized, multi-centre, open-label study. Primary Investigator Neil Berinstein, MD, Affiliate Scientist, Sunnybrook Research Institute, Professor of Medicine/Immunology, University of Toronto, is leading the trial, which is expected to enroll 25 evaluable participants whose recurrent DLBCL expresses survivin, a tumor antigen expressed in approximately 60 percent of DLBCL patients. The study’s primary endpoint is to document the objective response rate. Secondary objectives include measuring tumor regression, and documenting the toxicity profile and durations of response. In addition, researchers will perform analyses to assess circulating antigen specific immune responses and changes in tumor-infiltrating T cell immune responses within the tumor microenvironment. Investigators also plan to assess potential biomarkers of immune and clinical response.

About ICML

The International Conference on Malignant Lymphoma (ICML) is focused on the scientific community involved in the study and treatment of lymphoid neoplasms. The main aim of ICML is to facilitate the presentation of the most recent data—basic, translational and clinical—on lymphoma and encourage the discussion among hematologists, clinical oncologists, radiation oncologists, pediatricians, pathologists, and leading researchers from all over the world.

On May 3, 2019 Seattle Genetics, Inc. (Nasdaq:SGEN) reported that Health Canada has approved the supplemental New Drug Submission that expands the use of ADCETRIS (brentuximab vedotin) in combination with AVD (Adriamycin, vinblastine and dacarbazine) chemotherapy in patients with previously untreated Stage IV Hodgkin lymphoma (HL) (Press release, Seattle Genetics, MAY 3, 2019, View Source [SID1234535704]). The approval is based on positive results of the phase 3 ECHELON-1 clinical trial that compared ADCETRIS plus AVD to ABVD (Adriamycin, bleomycin, vinblastine and dacarbazine). In addition, a supplemental New Drug Submission was recently submitted to Health Canada for ADCETRIS in combination with CHP (cyclophosphamide, doxorubicin, prednisone) in patients with previously untreated CD30-expressing peripheral T-cell lymphoma (PTCL) based on the positive phase 3 ECHELON-2 clinical trial results. Health Canada granted a Priority Review Designation for this submission. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a defining marker of classical HL and expressed on the surface of several types of PTCL.

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"The Health Canada approval of ADCETRIS in combination with AVD chemotherapy in advanced-stage (Stage IV) Hodgkin lymphoma represents the first major advance for patients in decades," said Kerry Savage, M.D., Medical Oncologist at the BC Cancer Agency, Professor of Medicine at the University of British Columbia and investigator on both the phase 3 ECHELON-1 and ECHELON-2 clinical trials. "Advanced-stage Hodgkin lymphoma tends to be more aggressive and difficult to treat. This new ADCETRIS-containing regimen demonstrated superior efficacy when compared to the standard of care ABVD chemotherapy in the phase 3 ECHELON-1 clinical trial supporting the Health Canada approval and represents a meaningful advance for this Hodgkin lymphoma patient population."

"Currently, up to 30 percent of newly diagnosed patients with advanced-stage Hodgkin lymphoma will experience disease progression after treatment with the current standard of care, representing a significant need for improved treatment options," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "With this new indication for ADCETRIS, physicians and eligible patients in Canada have access to this important new regimen for treating Stage IV Hodgkin lymphoma. We also recently submitted a supplemental New Drug Submission application to Health Canada, which was granted Priority Review Designation, for ADCETRIS in combination with chemotherapy in frontline PTCL, a milestone supporting our plans to expand ADCETRIS globally to patients in need."

In March 2018, the U.S. Food and Drug Administration (FDA) approved ADCETRIS in combination with AVD for the treatment of adult patients with previously untreated stage III or IV classical HL based on the results of the phase 3 ECHELON-1 clinical trial. In November 2018, the FDA approved ADCETRIS in combination with CHP for the treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing PTCL, including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified.

About Classical Hodgkin Lymphoma

Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Classical Hodgkin lymphoma is distinguished from other types of lymphoma by the presence of one characteristic type of cell, known as the Reed-Sternberg cell. The Reed-Sternberg cell expresses CD30.

About T-Cell Lymphomas

There are more than 60 subtypes of non-Hodgkin lymphomas which are broadly divided into two major groups: B-cell lymphomas, which develop from abnormal B-lymphocytes, and T-cell lymphomas, which develop from abnormal T-lymphocytes. There are many different forms of T-cell lymphomas, some of which are extremely rare. T-cell lymphomas can be aggressive (fast-growing) or indolent (slow-growing). PTCL accounts for approximately 10 percent of non-Hodgkin lymphoma cases in the U.S. and Europe and may be as high as 24 percent in parts of Asia.

About ADCETRIS

ADCETRIS is being evaluated broadly in more than 70 clinical trials in CD30-expressing lymphomas. These include three completed phase 3 trials: ECHELON-2 trial in frontline peripheral T-cell lymphomas, ECHELON-1 in previously untreated Hodgkin lymphoma, and ALCANZA in cutaneous T-cell lymphoma. The ongoing CHECKMATE 812 trial of ADCETRIS in combination with Opdivo (nivolumab) for relapsed/refractory Hodgkin lymphoma is ongoing.

ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

ADCETRIS injection for intravenous infusion has received FDA approval for six indications in adult patients with: (1) previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone, (2) previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine, (3) cHL at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation, (4) cHL after failure of auto-HSCT or failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (5) sALCL after failure of at least one prior multi-agent chemotherapy regimen, and (6) primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.

Health Canada granted ADCETRIS approval with conditions for relapsed or refractory Hodgkin lymphoma and sALCL in 2013, and non-conditional approval for post-autologous stem cell transplantation (ASCT) consolidation treatment of Hodgkin lymphoma patients at increased risk of relapse or progression in 2017, adults with pcALCL or CD30-expressing MF who have had prior systemic therapy in 2018, and for previously untreated Stage IV Hodgkin lymphoma in combination with doxorubicin, vinblastine, and dacarbazine in 2019.

ADCETRIS received conditional marketing authorization from the European Commission in October 2012. The approved indications in Europe are: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following ASCT, or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, (2) for the treatment of adult patients with relapsed or refractory sALCL, (3) for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT, (4) for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy and (5) for the treatment of adult patients with previously untreated CD30-positive Stage IV Hodgkin lymphoma in combination with AVD (Adriamycin, vinblastine and dacarbazine).

ADCETRIS has received marketing authorization by regulatory authorities in 72 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See select important safety information, including Boxed Warning, below.

Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.

On May 3, 2019 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported its financial results and operational highlights for the quarter ended March 31, 2019 (Press release, Oncolytics Biotech, MAY 3, 2019, View Source [SID1234535703]). All dollar amounts are expressed in Canadian currency unless otherwise noted.

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”Our primary focus remains the breast cancer program and the timely completion of our AWARE-1 study of pelareorep in combination with the immune checkpoint inhibitor Tecentriq. We remain on track to report interim data in the second half of this year,” said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech. ”We expect the results of this important study to confirm the clinical utility of using T cell clonality as a biomarker for patient response to pelareorep, as well as pelareorep’s ability to prime the immune system to recognize cancer cells and enhance the potential efficacy of checkpoint inhibitors. This data will assist in the final design of our registrational study of pelareorep as a treatment for metastatic breast cancer and serve to confirm the broader utility of this biomarker, currently established in pancreatic cancer and multiple myeloma, across multiple cancer types.”

Selected highlights since January 1, 2019

Clinical & Scientific Updates

Announced the identification of T cell clonality as a potentially predictive and prognostic biomarker of pelareorep therapy in a poster presentation delivered at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2019 annual meeting
Treated the first patient in the AWARE-1 window of opportunity study, which is being conducted in collaboration with SOLTI, in which patients will receive the appropriate intervention for their breast cancer sub-type plus pelareorep with or without Roche’s anti PD-L1 Tecentriq, followed by surgery
Published data in the journal Blood Advances highlighting the synergistic effect of pelareorep in combination with proteasome inhibitor bortezomib for the treatment of multiple myeloma
Hosted a key opinion leader meeting with investors and analysts to discuss the emerging role of biomarkers and oncolytic viruses in the treatment of cancer, featuring Dirk Arnold, MD, PhD, Executive Board Member of the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) and Chief of Oncology at Asklepios Klinik Altona
Anticipated Milestones

Publish and present findings at leading U.S. and European oncology conferences including ASCO (Free ASCO Whitepaper), ESMO (Free ESMO Whitepaper) and ASH (Free ASH Whitepaper)
Initiate combination study with Merck’s Keytruda in multiple myeloma in mid-2019*
Expect to report interim data from AWARE-1 study in the second half of 2019
Prepare for registration study with pelareorep in mBC after AWARE-1
* Guidance provided by principal investigator

Financial

At March 31, 2019, the company reported $14.2 million in cash and cash equivalents
As at May 2, 2019, the company had an unlimited number of authorized common shares with 20,298,482 common shares issued and outstanding, 16,443,500 warrants exercisable into 1,730,894 common shares with a $9.025 strike price and 1,567,510 options and share units
Operating expense for the first quarter of 2019 was $1.8 million compared to $1.8 million in the first quarter 2018
Research and development expense for the first quarter of 2019 was $3.2 million compared to $2.9 million in the first quarter 2018
The net loss for the first quarter of 2019 was $4.9 million compared to $4.7 million in the first quarter 2018, which equates to a loss of $0.27 per share in 2019 compared to a net loss of $0.31 per share in 2018, on a consolidated basis
About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On May 3, 2019 Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported preliminary data showing promising early clinical responses in the first part of a two part study of Oraxol (oral paclitaxel and encequidar, also known as HM30181A) monotherapy in patients with unresectable cutaneous angiosarcoma (Press release, Athenex, MAY 3, 2019, View Source;p=RssLanding&cat=news&id=2397066 [SID1234535700]).

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To date, 10 patients have been enrolled in the clinical study, which is being conducted in four sites in the U.S. and Hong Kong. The first 7 patients have received at least six weeks of treatment, which is the timepoint for the first response assessment; 3 patients have not yet reached the first assessment timepoint. Oraxol is being administered once daily for three consecutive days every week during the treatment period.

All 7 patients showed significant and visible reduction of the cutaneous angiosarcoma within one or two weeks of treatment. Three patients had complete responses based on RECIST v1.1 criteria, with two complete responses occurring by 6 weeks of treatment.

Selected images showing early visible response in one week, from a patient with complete response (Patient A) are available at

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Selected images showing a patient with complete response after 6 weeks of treatment (Patient B) are available at

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None of the patients enrolled have discontinued treatment due to death, disease progression, or adverse events. No peripheral neuropathy has been reported.

Based on the preliminary data, the study has met the criteria required to proceed to full enrollment.

Dr. Rudolf Kwan, Chief Medical Officer of Athenex, stated, "I am impressed by the rapid clinical response to Oraxol monotherapy treatment in this group of difficult-to-treat patients. The high response rate observed, including three patients who had early complete response, is consistent with the hypothesis that oral delivery of paclitaxel can potentially achieve a more desirable pharmacokinetic profile and a better clinical outcome. I believe the good tolerance of Oraxol in this older patient population would be welcome by both clinicians and patients. This may represent a paradigm shift in the treatment of patients with cutaneous angiosarcoma."

Dr. Johnson Lau, Chairman and Chief Executive Officer of Athenex, commented, "The consistently high response rate observed in various clinical settings, including in the treatment of metastatic breast cancer, unresectable gastric cancer, and now cutaneous angiosarcoma, highlight the potential of Oraxol as an effective therapeutic for a broad range of cancers. With results showing high response rates, lack of significant neuropathy and oral convenience with no need for concomitant use of intravenous steroid pre-treatment, I believe Oraxol also has the potential to transform treatment regimens that use a high potency chemotherapeutic agent in combination with other newly developed anti-cancer therapeutics. We are already evaluating the combination of Oraxol with ramucirumab and Oraxol with an anti-PD1 (pembrolizumab) in clinical studies."

Oraxol (oral paclitaxel and encequidar, or HM30181A) was granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of angiosarcomas in April 2018.

The clinical trial, designed and led by Principal Investigator Vinod Ravi, M.D., associate professor of Sarcoma Medical Oncology at The University of Texas MD Anderson Cancer Center, is open at MD Anderson in Houston, Fred Hutchinson Cancer Center in Seattle and Prince of Wales Hospital, Shatin, in Hong Kong. For more details about the clinical study, please visit ClinicalTrials.gov at View Source

Athenex is completing a Phase III clinical trial of Oraxol in the treatment of metastatic breast cancer. In April 2019, the company presented an abstract on preclinical data of oral paclitaxel and HM30181A (encequidar) in angiosarcoma at the American Association of Cancer Research Annual Meeting 2019 in Atlanta, Georgia. In December 2018, Athenex announced positive second cohort results of Oraxol-plus-ramucirumab Phase 1b clinical trial in gastric cancer (more details can be found here). In October 2018, Athenex presented encouraging clinical trial efficacy and safety results of Oraxol in the treatment of metastatic breast cancer in a Phase II clinical trial in Taiwan at ESMO (Free ESMO Whitepaper) 2018 (more details can be found here).

The Orascovery platform was initially developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi.

About Angiosarcoma
Angiosarcomas are a type of soft tissue sarcoma characterized by rapidly proliferating, extensively infiltrating, anaplastic cells derived from blood and lymphatic vessels. Angiosarcomas arise in various body sites, including cutaneous, soft tissue, and visceral locations. Angiosarcomas are frequently metastatic at diagnosis, with a natural history complicated by local recurrence, distant metastases, and poor overall survival. Angiosarcomas represent about 2% of soft tissue sarcomas and 5.4% of cutaneous soft tissue sarcomas.

There is no approved treatment for angiosarcoma and survival is limited with treatments currently available. However, reports in the literature of objective tumor response support the use of intravenous paclitaxel in the treatment of angiosarcoma.