On May 16, 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the US Food and Drug Administration (FDA) has approved Venclexta (venetoclax) in combination with Gazyva (obinutuzumab) for the treatment of people with previously untreated chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) (Press release, Hoffmann-La Roche, MAY 16, 2019, View Source [SID1234536389]).

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!

"Venclexta plus Gazyva is the only chemotherapy-free option of fixed duration that provides durable responses to help people live longer without progression of their disease, compared to a standard-of-care," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "Today’s approval represents our long-standing commitment to helping people with blood cancers throughout the course of their disease, and we are excited to provide this new option for untreated chronic lymphocytic leukaemia."

The approval is based on the results of the randomised phase III CLL14 study, which evaluated 12-month, fixed-duration treatment with Venclexta plus Gazyva compared to Gazyva plus chlorambucil. Results showed the combination of Venclexta plus Gazyva produced a durable and significant reduction in the risk of disease worsening or death (progression-free survival [PFS], as assessed by Independent Review Committee) by 67% compared to Gazyva plus chlorambucil, a current standard-of-care (HR=0.33; 95% CI 0.22-0.51; p<0.0001). Venclexta plus Gazyva showed deep and clinically meaningful responses characterised by a higher rate of minimal residual disease (MRD)-negativity in the bone marrow compared to Gazyva plus chlorambucil (MRD-negativity of 57% vs. 17%) and peripheral blood (MRD-negativity of 76% vs. 35%). MRD-negativity means no cancer can be detected using a specific and highly sensitive test, defined as less than one CLL cell in 10,000 white blood cells.

Results of the study will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2019. The CLL14 study is being conducted in cooperation with the German CLL Study Group (GCLLSG), headed by Michael Hallek, MD, University of Cologne.

The most common adverse reactions with Venclexta plus Gazyva were low white blood cell count, diarrhoea, fatigue, nausea, low red blood cell count, and upper respiratory tract infection.

The FDA rapidly reviewed and approved the supplemental New Drug Application (sNDA) under the FDA’s Real-Time Oncology Review (RTOR) and Assessment Aid pilot programmes. This is the second regimen of Roche medicines approved under the RTOR pilot programme, which is exploring a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. The sNDA was also granted Priority Review, a designation given to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease. The FDA previously granted Breakthrough Therapy Designation for Venclexta in combination with Gazyva for the treatment of previously untreated CLL with co-existing medical conditions. Additional submissions of the CLL14 data to health authorities around the world are ongoing.

Venclexta is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche group, in the US and commercialised by AbbVie outside of the US.

About the CLL14 Study
CLL14 (NCT02242942) is a randomised phase III study evaluating the combination of fixed-duration Venclexta plus Gazyva compared to Gazyva plus chlorambucil in patients with previously untreated chronic lymphocytic leukaemia (CLL) and co-existing medical conditions. 432 patients with previously untreated CLL were randomly assigned to receive either a 12-month duration of Venclexta alongside six-month duration of Gazyva (Arm A) or six-month duration of Gazyva plus chlorambucil followed by an additional six-month duration of chlorambucil (Arm B). Arm A started with an initial cycle of Gazyva followed by a five-week Venclexta dose ramp-up to help reduce tumour burden. The primary endpoint of the study is investigator-assessed progression-free survival (PFS). Secondary endpoints include PFS assessed by independent review committee (IRC), minimal residual disease (MRD) status, overall response (OR), complete response (with or without complete blood count recovery, CR/CRi), overall survival (OS), duration of response (DOR), event-free survival (EFS), time to next CLL treatment (TTNT) and safety. The CLL14 study is being conducted in cooperation with the German CLL Study Group (GCLLSG), headed by Michael Hallek, MD, University of Cologne.

The most common adverse reactions with Venclexta plus Gazyva were low white blood cell count, diarrhoea, fatigue, nausea, low red blood cell count, and upper respiratory tract infection.

About Venclexta/Venclyxto (venetoclax)
Venclexta/Venclyxto is a first-in-class targeted medicine designed to selectively bind and inhibit the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers and other tumours, BCL-2 builds up and prevents cancer cells from dying or self-destructing, a process called apoptosis. Venclexta/Venclyxto blocks the BCL-2 protein and works to restore the process of apoptosis.
Venclexta/Venclyxto is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the US and commercialised by AbbVie, under the brand name Venclyxto, outside of the US. Together, the companies are committed to research with Venclexta/Venclyxto, which is currently being studied in clinical trials across several types of blood and other cancers.

In the US, Venclexta has been granted five Breakthrough Therapy Designations by the US Food and Drug Administration: one for previously untreated CLL, two for relapsed or refractory CLL and two for previously untreated acute myeloid leukaemia.

About Gazyva/Gazyvaro (obinutuzumab)
Gazyva/Gazyvaro is an engineered monoclonal antibody designed to attach to CD20, a protein expressed on certain B cells, but not on stem cells or plasma cells. Gazyva/Gazyvaro is designed to attack and destroy targeted B-cells both directly and together with the body’s immune system. Gazyva is marketed as Gazyvaro in the EU and Switzerland.

Gazyva/Gazyvaro is currently approved in more than 90 countries in combination with chlorambucil for people with previously untreated chronic lymphocytic leukaemia, in more than 80 countries in combination with bendamustine for people with certain types of previously treated follicular lymphoma and in more than 70 countries in combination with chemotherapy for previously untreated follicular lymphoma.

Additional combination studies investigating Gazyva/Gazyvaro with other approved or investigational medicines, including cancer immunotherapies and small molecule inhibitors, are underway across a range of blood cancers.

About the German CLL Study Group (GCLLSG)
Founded in 1996 and headed by Michael Hallek, MD, the GCLLSG has been running various phase III, phase II and phase I trials in chronic lymphocytic leukaemia (CLL) with the goal to provide optimal treatment to patients suffering from this disease. Among those were landmark trials like the CLL8 and the CLL11 trials which led to the current standard of care in CLL. For many years, GCLLSG has been aiming to improve not just the treatment of younger and physically fit patients, but also that of elderly and less fit patients. These patients are generally underrepresented in clinical trials although they constitute the majority of CLL patients treated by doctors in daily practice. The GCLLSG is an independent non-profit research organisation supported by the German Cancer Aid (Deutsche Krebshilfe) www.dcllsg.de.

About Roche in haematology
Roche has been developing medicines for people with malignant and non-malignant blood diseases for over 20 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera/Rituxan (rituximab), Gazyva/Gazyvaro (obinutuzumab), Venclexta/Venclyxto (venetoclax) in collaboration with AbbVie, and Hemlibra (emicizumab). Our pipeline of investigational haematology medicines includes polatuzumab vedotin, an anti-CD79b antibody drug conjugate; idasanutlin, a small molecule which inhibits the interaction of MDM2 with p53; T-cell engaging bispecific antibodies targeting both CD20 and CD3, and Tecentriq (atezolizumab), a monoclonal antibody designed to bind with PD-L1. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.

On May 16, 2019 Genocea Biosciences, Inc. (NASDAQ: GNCA), a biopharmaceutical company developing personalized cancer immunotherapies, reported the first clinical results from its ongoing Phase 1/2a trial for GEN-009, the company’s lead neoantigen vaccine candidate (Press release, Genocea Biosciences, MAY 16, 2019, View Source [SID1234536412]). Genocea employs its ATLAS platform for patient-specific neoantigen selection, using each patient’s own T cells to identify the neoantigens to which each patient mounts anti-tumor cytokine responses.

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 date, we have analyzed full immune response data from three patients following their priming series of three vaccinations and have detected immune responses to 93% of the total administered neoantigens, a response rate that would be best-in-class if seen across the full vaccinated cohort," said Tom Davis, M.D., Genocea’s Chief Medical Officer. "We are studying a diverse group of patients and, despite this variability, we are seeing consistently broad immune responses, including ex vivo CD8+ T cell responses, which have not previously been detected after monotherapy with a neoantigen vaccine. We expect to present more detailed immunogenicity and safety data from these and additional patients at the upcoming meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)."

ASCO POSTER SESSION: Developmental Immunotherapy and Tumor Immunobiology
Poster Board: #255 • *Abstract 2611
Title:
A phase 1/2a study of GEN-009, a neoantigen vaccine based on autologous peptide immune responses
Presenter:
Roger B. Cohen, M.D., University of Pennsylvania Perelman School of Medicine
Date:
Saturday, June 1, 8:00 AM – 11:00 AM Central Time
Location:
Hall A

*Note: The abstract was submitted prior to the availability of the immunogenicity data being reported today.

Conference Call and Webcast – June 3rd at 8:30 am ET
Genocea will host a conference call and webcast to discuss the clinical results presented at ASCO (Free ASCO Whitepaper) at 8:30 am ET on June 3, 2019. Interested participants may access the conference call by dialing (844) 826-0619 (domestic) or (315) 625-6883 (international) and referring to conference ID number 9068006. To join the live webcast, please visit the presentation page of the investor relations section of the Genocea website at View Source A webcast replay of the conference call will be available on the Genocea website beginning approximately two hours after the event and will be archived for 90 days.

On May 16, 2019 Sanofi and Regeneron Pharmaceuticals, Inc. reported that positive updated data for Libtayo (cemiplimab-rwlc) in locally advanced and metastatic cutaneous squamous cell carcinoma (CSCC) will be shared at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from May 31 to June 4 in Chicago (Press release, Sanofi Genzyme, MAY 16, 2019, View Source [SID1234536428]). Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 and is the first and only treatment approved and available for patients with metastatic CSCC or locally advanced CSCC who are not candidates for curative surgery or curative radiation in the U.S.

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!

These data from the pivotal Phase 2 EMPOWER-CSCC-1 trial include the primary analysis for the locally advanced CSCC group and longer-term data from the metastatic CSCC group. Together, they provide updated Libtayo efficacy and safety outcomes following its approval by the U.S. Food and Drug Administration (FDA) in September 2018 and will be shared alongside two additional joint Sanofi and Regeneron abstracts on CSCC.

Key data from EMPOWER-CSCC-1 published online in advance of ASCO (Free ASCO Whitepaper) include:

Locally Advanced CSCC

(n=78a)

Metastatic CSCC

(n=59b)

Median follow upa

9 months

(Range: 1 to 28 months)

17 months

(Range: 1 to 27 months)

Overall response rated

(n; 95% confidence interval [CI])

44%

(34; 32%, 55%)

49%

(29; 36%, 63%)

Complete responsed

13% (10)

17% (10)

Partial responsed

31% (24)

32% (19)

Median duration of response (DOR)

Not yet reached

Not yet reached

Median observed time to response

2 months

(Range: 2 to 9 months)

2 months

(Range: 2 to 9 months)

Durable disease control rate (DCR) of ≥16 weekse

63%

(95% CI: 51% to 74%)

63%

(95% CI: 49% to 75%)

Median progression free survival

Not yet reached

18 months

(95% CI: 7 months to not evaluable)

Median overall survival

Not yet reached

Not yet reached

a October 10, 2018 data cutoff

b September 20, 2018 data cutoff

c Excluding survival follow-up

d As assessed by central review

e Durable DCR includes stable disease or response

Among patients with locally advanced CSCC, the most common adverse events (AEs) were fatigue (42%), diarrhea and pruritus (both 27%) and nausea (22%). Grade 3 or higher immune-related AEs occurred in 10% of patients; one patient died due to an unknown cause assessed as treatment-related. Among patients with metastatic CSCC, the most common AEs were diarrhea (29%), fatigue (25%) and nausea (24%). Investigator-assessed Grade 3 or higher immune-related AEs occurred in 14% of patients.

In addition to the EMPOWER-CSCC-1 data, Sanofi and Regeneron are also sharing results from the largest retrospective data set of patients with metastatic or locally advanced CSCC who were treated with chemotherapy or an EGFR (epidermal growth factor receptor) inhibitor but who did not receive anti-PD-1 or anti-PD-L1 therapy.

Sanofi and Regeneron joint presentations at ASCO (Free ASCO Whitepaper) include:

Poster Discussion & Poster Sessions

Primary analysis of Phase 2 results of cemiplimab, a human monoclonal anti-PD-1, in patients with locally advanced cutaneous squamous cell carcinoma (Dr. Michael Migden; Saturday, June 1; Poster Display: 1:15-4:15 PM; Poster Discussion: 4:30-6:00 PM)
Phase 2 study of cemiplimab, a human monoclonal anti-PD-1, in patients with metastatic cutaneous squamous cell carcinoma (mCSCC; Group 1): 12 month follow-up (Dr. Alexander Guminski; Monday, June 3; Poster Display: 1:15-4:15 PM)

Publication-Only Abstracts

Treatment patterns and outcomes among patients with advanced cutaneous squamous cell carcinoma in a US community oncology setting (Dr. C. Lance Cowey; Publication Only)
Patterns of major surgeries among patients diagnosed with cutaneous squamous cell carcinoma (Chieh-I Chen; Publication Only)

Libtayo is being jointly developed by Sanofi and Regeneron under a global collaboration agreement.

About CSCC

CSCC is the second most common type of skin cancer in the world, accounting for approximately 20% of all skin cancers, and the number of newly diagnosed cases is expected to rise substantially in many countries. Although CSCC has a good prognosis when caught early, the cancer can prove especially difficult to treat effectively when it is advanced, and patients can experience reduced quality of life due to the impact of the disease as it progresses. Advanced CSCC is the deadliest non-melanoma skin cancer. While estimates vary, sources suggest that 7,000 people in the U.S. die annually of advanced CSCC.

About Libtayo

Libtayo is approved in the U.S., Canada and Brazil, and under review by the European Commission following a positive opinion by the Committee for Medicinal Products for Human Use (CHMP). In the U.S., Libtayo is approved for the treatment of patients with metastatic CSCC or locally advanced CSCC who are not candidates for curative surgery or curative radiation. The generic name for Libtayo in the U.S. is cemiplimab-rwlc, with rwlc as the suffix designated in accordance with Nonproprietary Naming of Biological Products Guidance for Industry issued by the U.S. FDA.

Libtayo is also being investigated in potential registrational trials in non-small cell lung cancer, basal cell carcinoma and cervical cancer, along with additional trials in squamous cell carcinoma of the head and neck, melanoma, colorectal cancer, prostate cancer, multiple myeloma, Hodgkin’s lymphoma and non-Hodgkin’s lymphoma. These trials are designed to investigate Libtayo as monotherapy; in combination with conventional treatments like chemotherapy; or in combination with other investigational agents, including vaccines, oncolytic viruses and bispecific antibodies, among others. These potential uses are investigational, and their safety and efficacy have not been evaluated by any regulatory authority.

IMPORTANT SAFETY INFORMATION AND INDICATION FOR U.S. PATIENTS

What is the most important information I should know about Libtayo?

Libtayo is a medicine that may treat a type of skin cancer by working with your immune system. Libtayo can cause your immune system to attack normal organs and tissues in any area of your body and can affect the way they work. These problems can sometimes become severe or life-threatening and can lead to death. These problems may happen anytime during treatment or even after your treatment has ended.

Call or see your healthcare provider right away if you develop any symptoms of the following problems or these symptoms get worse:

Lung problems (pneumonitis). Signs and symptoms of pneumonitis may include new or worsening cough, shortness of breath, and chest pain.
Intestinal problems (colitis) that can lead to tears or holes in your intestine. Signs and symptoms of colitis may include diarrhea (loose stools) or more frequent bowel movements than usual; stools that are black, tarry, sticky or that have blood or mucus; and severe stomach-area (abdomen) pain or tenderness.
Liver problems (hepatitis). Signs and symptoms of hepatitis may include yellowing of your skin or the whites of your eyes, severe nausea or vomiting, pain on the right side of your stomach area (abdomen), drowsiness, dark urine (tea colored), bleeding or bruising more easily than normal, and feeling less hungry than usual.
Hormone gland problems (especially the adrenal glands, pituitary, thyroid and pancreas). Signs and symptoms that your hormone glands are not working properly may include headaches that will not go away or unusual headaches, rapid heartbeat, increased sweating, extreme tiredness, weight gain or weight loss, dizziness or fainting, feeling more hungry or thirsty than usual, hair loss, feeling cold, constipation, deeper voice, very low blood pressure, urinating more often than usual, nausea or vomiting, stomach-area (abdomen) pain, and changes in mood or behavior, such as decreased sex drive, irritability, or forgetfulness.
Kidney problems, including nephritis and kidney failure. Signs of these problems may include decrease in your amount of urine, blood in your urine, swelling in your ankles, and loss of appetite.
Skin problems. Signs of these problems may include rash, itching, skin blistering, and painful sores or ulcers in the mouth, nose, throat, or genital area.
Problems in other organs. Signs of these problems may include headache, tiredness or weakness, sleepiness, changes in heartbeat (such as beating fast, seeming to skip a beat, or a pounding sensation), confusion, fever, muscle weakness, balance problems, nausea, vomiting, stiff neck, memory problems, seizures (encephalitis), swollen lymph nodes, rash or tender lumps on skin, cough, shortness of breath, vision changes, or eye pain (sarcoidosis), seeing or hearing things that are not there (hallucinations), severe muscle weakness, low red blood cells (anemia), bruises on the skin or bleeding, and changes in eyesight.
Rejection of a transplanted organ. Your doctor should tell you what signs and symptoms you should report and monitor you, depending on the type of organ transplant that you have had.
Infusion (IV) reactions that can sometimes be severe and life-threatening. Signs of these problems may include chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness, fever, feeling of passing out, back or neck pain, and facial swelling.

Getting medical treatment right away may help keep these problems from becoming more serious.

Your healthcare provider will check you for these problems during your treatment with Libtayo. Your healthcare provider may treat you with corticosteroid or hormone replacement medicines. Your healthcare provider may delay or completely stop treatment if you have severe side effects.

Before you receive Libtayo, tell your healthcare provider about all your medical conditions, including if you:

have immune system problems such as Crohn’s disease, ulcerative colitis, or lupus;
have had an organ transplant;
have lung or breathing problems;
have liver or kidney problems;
have diabetes;
are pregnant or plan to become pregnant; Libtayo can harm your unborn baby.
Females who are able to become pregnant:

Your healthcare provider will give you a pregnancy test before you start treatment.
You should use an effective method of birth control during your treatment and for at least 4 months after your last dose of Libtayo. Talk with your healthcare provider about birth control methods that you can use during this time.
Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Libtayo.
are breastfeeding or plan to breastfeed. It is not known if Libtayo passes into your breast milk. Do not breastfeed during treatment and for at least 4 months after the last dose of Libtayo.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of Libtayo include tiredness, rash, and diarrhea. These are not all the possible side effects of Libtayo. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Regeneron Pharmaceuticals and Sanofi at 1-877-542-8296.

Please see accompanying full Prescribing Information, including Medication Guide.

What is Libtayo?

Libtayo is a prescription medicine used to treat people with a type of skin cancer called cutaneous squamous cell carcinoma (CSCC) that has spread or cannot be cured by surgery or radiation.

It is not known if Libtayo is safe and effective in children.

On May 16, 2019 Oncorus, Inc., an oncolytic virus therapeutics company focused on driving innovation to transform outcomes for cancer patients, reported that its President and Chief Executive Officer, Ted Ashburn, M.D., Ph.D., will provide a company overview and pipeline update at the following upcoming healthcare investor conferences in New York City (Press release, Oncorus, MAY 16, 2019, View Source [SID1234536444]):

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!

UBS Global Healthcare Conference on Tuesday, May 21, 2019 at 1:30 p.m. ET
Jefferies 2019 Healthcare Conference on Wednesday, June 5, 2019 at 9:30 a.m. ET

On May 16, 2019 AstraZeneca reported that it will present new research across an industry-leading Oncology portfolio, including data for its transformational cancer medicines Lynparza (olaparib) and Imfinzi (durvalumab) at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, US, 31 May to 4 June 2019 (Press release, AstraZeneca, MAY 16, 2019, View Source [SID1234536390]).

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!

In all, the Company will present 93 abstracts spanning multiple tumour types, including 12 oral presentations with one plenary session and four late-breakers. Highlights include:

Late-breaking results from the Lynparza POLO trial, the first positive Phase III trial of any PARP inhibitor in germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer, a devastating diagnosis with critical unmet medical need. This is the first Phase III trial to validate a targeted treatment in a biomarker-selected population of pancreatic cancer.
Results of the Phase III SOLO-3 trial highlighting the efficacy for Lynparza monotherapy vs. standard-of-care chemotherapy in treating patients with gBRCAm advanced ovarian cancer who had two or more prior lines of treatment. This data underscores Lynparza’s clinical benefit irrespective of line of treatment for women with BRCAm advanced ovarian cancer and the importance of knowing BRCA status at diagnosis.
Three-year overall survival (OS) data from the Phase III PACIFIC trial providing new evidence of the long-term survival benefit for Imfinzi in unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease had not progressed following chemoradiation therapy. Imfinzi is the only immunotherapy to demonstrate significant OS benefits in this curative-intent setting, and this data reaffirms the PACIFIC regimen as the standard of care for these patients.
Dave Fredrickson, Executive Vice President, Oncology, said: "AstraZeneca continues to break traditional treatment boundaries through new targeted approaches and the prioritisation of earlier intervention. This year at ASCO (Free ASCO Whitepaper), our data for Lynparza in BRCA-mutated metastatic pancreatic cancer and for Imfinzi in unresectable Stage III non-small cell lung cancer illustrate our ambition to change medical practice for better patient outcomes."

Breaking treatment boundaries

AstraZeneca is committed to redefining disease treatment for patient populations with unmet needs. This will be evidenced at the ASCO (Free ASCO Whitepaper) meeting for patients with PARP-mediated tumours, HER2-low expressing tumours, and AKT-mutated tumours.

The plenary presentation of results from the Phase III POLO trial will detail the progression-free survival (PFS) and important clinical benefit of Lynparza in patients with metastatic pancreatic cancer, a population that has seen very little treatment progress over the past 40 years (Abstract #LBA4).

New data on Lynparza will also be shared in advanced ovarian cancer, including the results of the Phase III SOLO-3 trial highlighting the efficacy for Lynparza monotherapy vs. standard-of-care chemotherapy in treating patients with gBRCAm advanced ovarian cancer who had two or more prior lines of treatment (Abstract #5506).

Furthermore, the Phase II TOPARP-B trial, sponsored by the Institute of Cancer Research (UK), will highlight the anti-tumour activity of Lynparza in patients with heavily-pretreated metastatic castration-resistant prostate cancer with DDR gene defects (Abstract #5005). The Phase II GeparOLA trial, conducted by the German Breast Group and German AGO-B Breast Study Group, will help define the safety and efficacy of Lynparza, compared to platinum-based chemotherapy, in the neoadjuvant setting in HER2-negative early breast cancer and in patients with homologous recombination deficiency (Abstract #506).

The design of the Phase III DESTINY-Breast04 trial evaluating trastuzumab deruxtecan (DS-8201) in metastatic breast cancer with HER2-low expressing tumours will be presented at this year’s ASCO (Free ASCO Whitepaper) meeting (Abstract #TPS1102). The antibody drug conjugate (ADC) co-developed with Daiichi Sankyo has the potential to redefine breast cancer treatment. Two publications in Lancet Oncology recently highlighted the Phase I dose-expansion results for trastuzumab deruxtecan in HER2-positive metastatic breast and gastric cancers.

In addition, data will be presented from the Phase II FAKTION trial, sponsored by Velindre NHS Trust, on the combination of the AKT inhibitor capivasertib (AZD5363) plus Faslodex (fulvestrant) in patients with relapsed metastatic oestrogen receptor (ER)-positive breast cancer (Abstract #1005). AKT mutations occur across several different cancers and may be a target for treatment tailored to tumour genes rather than cancer types.

Treating patients earlier in their disease

AstraZeneca made a significant breakthrough in the treatment of NSCLC beginning in 2017 with the Phase III PACIFIC trial demonstrating unprecedented PFS and subsequently OS benefits for patients with unresectable, Stage III NSCLC treated with Imfinzi vs. standard of care. At this year’s ASCO (Free ASCO Whitepaper) meeting, AstraZeneca will provide new evidence of the long-term survival benefit of Imfinzi with a three-year OS update (Abstract #8526).

Sub-analysis presentations of Phase III data from SOLO-1, the only trial of a PARP inhibitor to demonstrate improvement in PFS for women with BRCAm advanced ovarian cancer as a 1st-line maintenance treatment, will reinforce the potential of using Lynparza earlier in the treatment pathway (Abstract #5539).

Raising the bar for better outcomes

New data from the Phase III FLAURA trial will explore clinical outcomes associated with the detection of epidermal growth factor receptor (EGFR) mutations in plasma at three or six weeks after starting treatment with Tagrisso (osimertinib) (Abstract #9020). With the presentation of the Phase II SAVANNAH trial design, AstraZeneca will explain how it will explore the combination of Tagrisso and savolitinib to potentially overcome MET-driven EGFR tyrosine kinase inhibitor (TKI) resistance following Tagrisso treatment in EGFR-mutated NSCLC (Abstract #TPS9119).

Despite recent therapeutic progress, platinum-resistant ovarian cancer remains a therapeutic challenge. Results of a multicenter, double-blind Phase II trial conducted by the Princess Margaret, California, Chicago and Mayo Phase II Consortia will show for the first time increased OS data with the Wee-1 inhibitor adavosertib when associated with the antimetabolite medicine gemcitabine (Abstract #5518).

A focus on haematology

The diverse haematology pipeline aims to deliver new medicines in a range of blood cancers with critical unmet medical need

AstraZeneca has established haematology as one of its key areas of focus. At the ASCO (Free ASCO Whitepaper) meeting and the upcoming 24th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper), 13-16 June 2019, the Company will present long-term trial follow-up data showing the promising response rate, duration of response and safety profile of the Bruton’s tyrosine kinase (BTK) inhibitor Calquence (acalabrutinib) in chronic lymphocytic leukaemia (CLL), including:

Three-year results from the Phase Ib/II ACE-CL-003 trial evaluating Calquence and obinutuzumab in treatment-naïve and previously-treated CLL (Abstract #7500)
19-month results from the Phase II ACE-CL-208 trial of Calquence in patients with relapsed or refractory CLL intolerant to ibrutinib (Abstract #7530)
These data are part of a robust development programme that includes two pivotal clinical trials for Calquence in CLL with full data anticipated in 2019: the Phase III ASCEND (ACE-CL-309) trial in relapsed or refractory CLL, which recently met its primary endpoint, and the ongoing Phase III ELEVATE-TN (ACE-CL-007) trial evaluating Calquence with and without obinutuzumab in front-line CLL.

Key AstraZeneca presentations at ASCO (Free ASCO Whitepaper) 2019

Lead author

Abstract title

Presentation details

Immuno-Oncology

Gray, JE

Three-year overall survival update from the PACIFIC trial.

Abstract #8526

Poster Board #282

Poster Session – Lung Cancer – Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Sunday 2 June, 8:00-11:00am

Hall A

Planchard, D

First subsequent treatment after discontinuation of durvalumab in unresectable, Stage III NSCLC patients from PACIFIC.

Abstract #9054

Poster Board #377

Poster Session – Lung Cancer – Non-Small Cell Metastatic

Sunday 2 June, 8:00-11:00am

Hall A

Rizvi, NA

Blood tumor mutational burden (bTMB) and tumor PD-L1 as predictive biomarkers of survival in MYSTIC: first-line durvalumab (D) ± tremelimumab (T) vs chemotherapy (CT) in metastatic (m) NSCLC.

Abstract #9016

Poster Board #339

Poster Discussion – Lung Cancer – Non-Small Cell Metastatic

Sunday 2 June, 4:30-6:00pm

Hall D1

Garon, EB

Patient-reported outcomes (PROs) with first-line durvalumab (D) ± tremelimumab (T) vs chemotherapy (CT) in metastatic NSCLC: results from MYSTIC.

Abstract #9048

Poster Board #371

Poster Presentation – Lung Cancer – Non-Small Cell Metastatic

Sunday 2 June, 8:00-11:00am

Hall A

Bradley, JD

PACIFIC-2: phase 3 study of concurrent durvalumab and platinum-based chemoradiotherapy in patients with unresectable, stage III NSCLC.

Abstract #TPS8573

Poster Board #327a

Poster Presentation – Lung Cancer – Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Sunday 2 June, 8:00-11:00am

Hall A

DNA damage response

Kindler, H

Olaparib as maintenance treatment following first-line platinum-based chemotherapy (PBC) in patients (pts) with a germline BRCA mutation and metastatic pancreatic cancer (mPC): Phase III POLO trial.

Abstract #LBA4

Plenary Session Including the Distinguished Achievement Award and Science of Oncology Award Lecture

Sunday 2 June, 3:15-3:30pm

Hall B1

Penson, R

Olaparib monotherapy versus (vs) chemotherapy for germline BRCA-mutated (gBRCAm) platinum-sensitive relapsed ovarian cancer (PSR OC) patients (pts): Phase III SOLO3 trial.

Abstract #5506

Oral Abstract Session – Gynecologic Cancer

Monday 3 June, 3:15-3:27pm

S406

Colombo, N

Adverse events (AEs) with maintenance olaparib in newly diagnosed patients (pts) with advanced ovarian cancer (OC) and a BRCA mutation (BRCAm): Phase III SOLO1 trial.

Abstract #5539

Poster Board #362

Poster Session – Gynecologic Cancer

Saturday 1 June, 1:15-4:15pm

Hall A

Mateo, J

TOPARP-B: A phase II randomized trial of the poly(ADP)-ribose polymerase (PARP) inhibitor olaparib for metastatic castration resistant prostate cancers (mCRPC) with DNA damage repair (DDR) alterations.

Abstract #5005

Oral Abstract Session – Genitourinary (Prostate) Cancer

Friday 31 May, 4:09-4:21pm

Arie Crown Theater

Lheureux, S

A randomized double-blind placebo-controlled phase II trial comparing gemcitabine monotherapy to gemcitabine in combination with adavosertib in women with recurrent, platinum resistant epithelial ovarian cancer: A trial of the Princess Margaret, California, Chicago and Mayo Phase II Consortia.

Abstract #5518

Poster Board #341

Poster Session – Gynaecologic Cancer

Saturday 1 June, 4:30-6:00pm

Hall A

Fasching, P

GeparOLA: A randomized phase II trial to assess the efficacy of paclitaxel and olaparib in comparison to paclitaxel/carboplatin followed by epirubicin/cyclophosphamide as neoadjuvant chemotherapy in patients (pts) with HER2-negative early breast cancer (BC) and homologous recombination deficiency (HRD).

Abstract #506

Oral Abstract Session – Breast Cancer -Local/Regional/Adjuvant

Monday 3 June, 11:45-11:57pm

Hall D2

Tumour drivers and resistance

Oxnard, GR

SAVANNAH: A Phase II trial of osimertinib plus savolitinib for patients (pts) with EGFR-mutant, MET-driven (MET+), locally advanced or metastatic non-small cell lung cancer (NSCLC), following disease progression on osimertinib.

Abstract #TPS9119

Poster Board #439b

Poster Session – Lung Cancer – Non-Small Cell Metastatic

Sunday 2 June, 8:00-11:00am

Hall A

Zhou, C

Early clearance of plasma EGFR mutations as a predictor of response to osimertinib and comparator EGFR-TKIs in the FLAURA trial.

Abstract #9020

Poster Board #343

Poster Session – Lung Cancer – Non-Small Cell Metastatic

Sunday 2 June, 8:00-11:00am

Hall A

Jones, RH

Capivasertib (AZD5363) plus fulvestrant versus placebo plus fulvestrant after relapse or progression on an aromatase inhibitor in metastatic ER-positive breast cancer (FAKTION): A randomized, double-blind, placebo-controlled, phase II trial.

Abstract #1005

Oral Abstract Session – Breast Cancer – Metastatic

Tuesday 4 June, 11:09-11:21am

Hall D1

Haematology

Woyach, J

Acalabrutinib with obinutuzumab (Ob) in treatment-naive (TN) and relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL): Three-year follow-up.

Abstract #7500

Oral Abstract Session – Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia

Tuesday 4 June, 9:45-9:57am

E451

Rogers, KA

Phase 2 study of acalabrutinib in ibrutinib (IBR)-intolerant patients (pts) with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL).

Abstract #7530

Poster Board #284

Poster Session – Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia

Monday 3 June, 8:00-11:00am

Hall A

Trastuzumab deruxtecan (DS-8201)

Modi, S

A phase III, multicenter, randomized, open label trial of [fam-] trastuzumab deruxtecan (DS-8201a) versus investigator’s choice in HER2-low breast cancer.

Abstract #TPS1102

Poster Board #182a

Poster Session – Breast Cancer – Metastatic

Sunday 2 June, 8:00-11:00am

Hall A

In addition to the scientific presentations and press releases planned at the ASCO (Free ASCO Whitepaper) meeting, AstraZeneca and its partner MSD (MSD: known as Merck & Co., Inc. inside the US and Canada) will host a press briefing on Sunday 2 June, on Lynparza. For more information, please contact AstraZeneca Global Media Relations.

About AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in Oncology and offers a quickly-growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, we are committed to advance Oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to our core capabilities, we actively pursue innovative partnerships and investments that accelerate the delivery of our strategy as illustrated by our investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.