On May 19, 2021 AstraZeneca reported that it will present new data underscoring its ambition to redefine cancer care at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, 4 to 8 June 2021 (Press release, AstraZeneca, MAY 19, 2021, View Source [SID1234580250]).

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More than 100 abstracts will feature 21 approved and potential new medicines across the Company’s industry-leading oncology portfolio, with four abstracts selected as late-breakers, 12 oral presentations and one plenary presentation.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: "Our data at ASCO (Free ASCO Whitepaper) this year show our unwavering resolve to revolutionise cancer care and strengthen our leading portfolio in lung and breast cancers as well as haematology. New results for Lynparza and Imfinzi continue to validate our strategy of treating cancer early in settings with curative intent, and data for Calquence deliver on our commitment to improve the patient experience by demonstrating efficacy with safe, tolerable medicines."

Cristian Massacesi, Senior Vice President, Head of late-stage development, Oncology R&D said: "Over the past few years, the outlook for breast cancer patients with BRCA mutations has radically changed, and the OlympiA data at ASCO (Free ASCO Whitepaper) will represent another critical step forward. We have an opportunity to fundamentally change the prognosis for women with high-risk early disease and usher in a potential new standard of care in the adjuvant setting. Additionally, promising data in triple-negative breast cancer will challenge current treatment expectations and bring hope for new approaches in this aggressive form of the disease."

Redefining survival by treating cancer earlier
A plenary presentation of results from the OlympiA Phase III trial in early breast cancer will highlight the impact of Lynparza (olaparib) on the risk of disease recurrence versus placebo in the adjuvant treatment of patients with germline BRCA-mutated (gBRCAm) high-risk human epidermal growth factor receptor 2 (HER2)-negative early breast cancer. Lynparza is the first PARP inhibitor to demonstrate clinical benefit as an adjuvant treatment in early breast cancer. In February 2021, the trial’s Independent Data Monitoring Committee recommended moving to early primary analysis based on a planned interim analysis showing a sustainable and clinically relevant treatment effect in the primary endpoint of invasive disease-free survival.

Five-year overall survival data from the PACIFIC Phase III trial will continue to support the unprecedented and sustained survival benefits of Imfinzi (durvalumab) for patients with unresectable, Stage III non-small cell lung cancer (NSCLC) who have not progressed following concurrent chemoradiation therapy. These data represent the longest-ever survival reported in a Phase III trial of immunotherapy in this treatment setting.

Additionally, an oral presentation of Phase II data from the externally sponsored GeparNuevo trial conducted by the German Breast Group will show initial potential of Imfinzi to improve outcomes in patients with early triple-negative breast cancer (TNBC) when added to standard neoadjuvant chemotherapy.

Transforming the patient experience
Four-year follow-up data from the ELEVATE-TN trial will confirm the sustained clinical benefit of either Calquence monotherapy or Calquence in combination with obinutuzumab, providing flexibility to tailor treatment for adults with treatment-naïve chronic lymphocytic leukaemia (CLL).

In addition, an oral presentation of detailed results from the ELEVATE-RR Phase III trial will demonstrate significantly lower atrial fibrillation, fewer cardiac events and fewer discontinuations with Calquence (acalabrutinib) versus ibrutinib in adults with previously treated CLL at high risk for progression. ELEVATE-RR is the first head-to-head Phase III trial of two Bruton’s tyrosine kinase inhibitors in CLL, confirming the favourable benefit-risk profile of Calquence for patients with CLL.

Updated data from DESTINY-Gastric01 and DESTINY-CRC01 will further support the potential role of Enhertu (trastuzumab deruxtecan) across HER2-targetable cancers. Additionally, data from a subgroup analysis of previously treated HER2-positive breast cancer patients with brain metastases in the DESTINY-Breast01 trial will reinforce the commitment to understanding the potential benefit of Enhertu in hard-to-treat patient populations.

Initial results will be shared from the BEGONIA Phase Ib/II trial testing Imfinzi combinations in metastatic TNBC, including with Enhertu. Also, data will be shared from a Phase II trial with ceralasertib, an ataxia telangiectasia and rad3-related (ATR) kinase inhibitor, in combination with Imfinzi showing that this combination demonstrated promising anti-tumour activity in melanoma patients for whom prior anti-PD1 treatment had failed.

Additional evidence will underscore the need for improved central nervous system control and the role of next-generation tyrosine kinase inhibitors (TKIs) such as Tagrisso (osimertinib) in the treatment of advanced epidermal growth factor (EGFR)-mutated NSCLC, as shown in the REFLECT retrospective real-world analysis of first- and second-generation TKIs.

Advancing an industry-leading clinical development programme
In all, AstraZeneca will share 18 posters at ASCO (Free ASCO Whitepaper) describing trials-in-progress exploring novel medicines and combinations across multiple types and stages of cancer. These posters include:

Datopotamab deruxtecan (Dato-DXd) – the TROPION-Lung01 Phase III trial testing datopotamab deruxtecan in patients with previously treated metastatic NSCLC, and the BEGONIA trial testing Imfinzi in combination with datopotamab deruxtecan in metastatic TNBC
Enhertu – trials testing Enhertu alone or in various combinations, including: DESTINY-Breast07, DESTINY-PanTumor01, and DESTINY-CRC02
Imfinzi – the MATTERHORN Phase III trial of neoadjuvant-adjuvant Imfinzi and chemotherapy in resectable gastric and gastroesophageal junction cancer, and the BEGONIA Phase I/II trial testing Imfinzi in novel combinations for 1st-line treatment of patients with TNBC, including with Enhertu and datopotamab deruxtecan.
Calquence – the ESCALADE Phase III trial of Calquence in combination with standard chemotherapy for patients age 65 and younger newly diagnosed with diffuse large B-cell lymphoma, the most common type of non-Hodgkin lymphoma
Camizestrant (AZD9833) – the SERENA-4 Phase III trial comparing camizestrant, a next-generation oral selective oestrogen receptor degrader (SERD), plus palbociclib, versus anastrozole plus palbociclib, in patients with oestrogen receptor-positive, HER2-negative advanced breast cancer who have not previously received systemic treatment for advanced disease
Adavosertib – the ADAGIO Phase II multicentre trial of the WEE1 inhibitor adavosertib as a treatment for recurrent or persistent uterine serous carcinoma, a highly aggressive form of endometrial cancer
Collaboration in the scientific community is critical to improving outcomes for patients. Lynparza is developed and commercialised in collaboration with MSD (Merck & Co., Inc. in the US and Canada). AstraZeneca is collaborating with Daiichi Sankyo Company, Limited (Daiichi Sankyo) to develop and commercialise Enhertu and datopotamab deruxtecan globally.

Key AstraZeneca presentations during the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting1

Lead author

Abstract title

Presentation details2

Immuno-Oncology

Spigel, D

Five-year survival outcomes with durvalumab after chemoradiotherapy in unresectable stage III NSCLC: An update from the PACIFIC trial.

Abstract #8511

Poster Discussion Session

Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

4 June 2021

Janjigian, Y

MATTERHORN: Efficacy and safety of neoadjuvant-adjuvant durvalumab and FLOT chemotherapy in resectable gastric and gastroesophageal junction cancer—A randomized, double-blind, placebo-controlled, phase 3 study.

Abstract #TPS4151

Poster Session

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

4 June 2021

McCoon, P

T-cell receptor pharmacodynamics associated with survival and response to tremelimumab (T) in combination with durvalumab (D) in patients (pts) with unresectable hepatocellular carcinoma (uHCC).

Abstract #4087

Poster Session

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

4 June 2021

Schmid, P

BEGONIA: Phase 1b/2 study of durvalumab (D) combinations in locally advanced/metastatic triple-negative breast cancer (TNBC)—Initial results from arm 1, d+paclitaxel (P), and arm 6, d+trastuzumab deruxtecan (T-DXd).

Abstract #1023

Poster Discussion Session

Breast Cancer—Metastatic

4 June 2021

Schmid, P

BEGONIA: Phase 1b/2, open-label, platform study of the safety and efficacy of durvalumab (D) ± paclitaxel (P) with novel oncology therapies for first line metastatic triple-negative breast cancer (mTNBC): Addition of Arm 7, D + datopotamab deruxtecan (Dato-DXd; DS-1062).

Abstract #TPS1105

Poster Session

Breast Cancer—Metastatic

4 June 2021

Kwon, M

Phase II study of ceralasertib (AZD6738), in combination with durvalumab in patients with metastatic melanoma who have failed prior anti-PD-1 therapy.

Abstract #9514

Poster Discussion Session

Melanoma/Skin Cancers

4 June 2021

Suárez, C

Clinical activity of durvalumab and savolitinib in MET-driven, metastatic papillary renal cancer.

Abstract #4511

Poster Discussion Session

Genitourinary Cancer—Kidney and Bladder

4 June 2021

Tumour drivers and resistance

Janzic, U

Real-world outcomes and clinical characteristics of patients with brain metastases from EGFR mutated non-small cell lung cancer: Data from a large retrospective study (REFLECT).

Abstract #9086

Poster Session

Lung Cancer—Non-Small Cell Metastatic

4 June 2021

Im, S-A

SERENA-4: A phase 3 comparison of AZD9833 (camizestrant) plus palbociclib, versus anastrozole plus palbociclib, for patients with ER-positive, HER2-negative advanced breast cancer who have not previously received systemic treatment for advanced disease.

Abstract #TPS1101

Poster Session

Breast Cancer—Metastatic

4 June 2021

Tada, H

Adjuvant gefitinib versus cisplatin/vinorelbine in Japanese patients with completely resected, EGFR-mutated, stage II-III non-small cell lung cancer (IMPACT, WJOG6410L): A randomized phase 3 trial.

Abstract #8501

Oral Abstract Session

Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

6 June 2021

Antibody drug conjugates

Yoh, K

A randomized, phase 3 study of datopotamab deruxtecan (Dato-DXd; DS-1062) versus docetaxel in previously treated advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations (TROPION-Lung01).

Abstract #TPS9127

Poster Session

Lung Cancer – Non-small Cell Metastatic

4 June 2021

Andre, F

Trastuzumab deruxtecan (T-DXd) combinations in patients with HER2-positive advanced or metastatic breast cancer: A phase 1b/2, open-label, multicenter, dose-finding and dose-expansion study (DESTINY-Breast07).

Abstract #TPS1096

Poster Session

Breast Cancer—Metastatic

4 June 2021

Li, BT

A phase 2, multicenter, open-label study evaluating trastuzumab deruxtecan (T-DXd) for the treatment of solid tumors harboring specific HER2-activating mutations (DESTINY-PanTumor01).

Abstract #TPS3162

Poster Session

Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology

4 June 2021

Yoshino, T

Trastuzumab deruxtecan (T-DXd; DS-8201) in patients (pts) with HER2-expressing metastatic colorectal cancer (mCRC): Final results from a phase 2, multicenter, open-label study (DESTINY-CRC01).

Abstract #3505

Oral Abstract Session

Gastrointestinal Cancer—Colorectal and Anal

7 June 2021

Raghav, K

Trastuzumab deruxtecan in patients with HER2-overexpressing locally advanced, unresectable, or metastatic colorectal cancer (mCRC): A randomized, multicenter, phase 2 study (DESTINY-CRC02).

Abstract #TPS3620

Poster Session

Gastrointestinal Cancer—Colorectal and Anal

4 June 2021

Jerusalem, G

Trastuzumab deruxtecan (T-DXd) in patients with HER2+ metastatic breast cancer with brain metastases: a subgroup analysis of the DESTINY-Breast01 trial.

Abstract #526

Poster Session

Breast Cancer— Local/Regional/Adjuvant

4 June 2021

Yamaguchi, K

Trastuzumab deruxtecan (T-DXd; DS-8201) in patients with HER2-positive advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma: Final overall survival (OS) results from a randomized, multicenter, open-label, phase 2 study (DESTINY-Gastric01).

Abstract #4048

Poster Session

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

4 June 2021

DNA damage response

Tutt, A

OlympiA: A phase 3, multicenter, randomized, placebo-controlled trial of adjuvant olaparib after (neo)adjuvant chemotherapy in patients with germline BRCA1/2 mutations and high risk HER2-negative early breast cancer.

Abstract #LBA1

Plenary Session

6 June 2021, 1:00pm EDT

Liu, JF

ADAGIO: A phase IIb, open-label, single-arm, multicenter study assessing the efficacy and safety of adavosertib (AZD1775) as treatment for recurrent or persistent uterine serous carcinoma.

Abstract #TPS5612

Poster Session

Gynecologic Cancer

4 June 2021

Poveda, A

Olaparib maintenance monotherapy for non-germline BRCA1/2-mutated (non-gBRCAm) platinum-sensitive relapsed ovarian cancer (PSR OC) patients (pts): Phase IIIb OPINION primary analysis.

Abstract #5545

Poster Session

Gynecologic Cancer

4 June 2021

Matthews, CA

Olaparib treatment (Tx) in patients (pts) with platinum-sensitive relapsed ovarian cancer (PSR OC) by BRCA mutation (BRCAm) and homologous recombination deficiency (HRD) status: Overall survival (OS) results from the phase II LIGHT study.

Abstract #5515

Poster Discussion Session

Gynecologic Cancer

4 June 2021

Pautier, P

Progression-free survival (PFS) and second PFS (PFS2) by disease stage in patients (pts) with homologous recombination deficiency (HRD)-positive newly diagnosed advanced ovarian cancer receiving bevacizumab (bev) with olaparib/placebo maintenance in the phase III PAOLA-1/ENGOT-ov25 trial.

Abstract #5514

Poster Discussion Session

Gynecologic Cancer

4 June 2021

Haematology

Byrd, J

First results of a head-to-head trial of acalabrutinib versus ibrutinib in previously treated chronic lymphocytic leukemia.

Abstract #7500

Oral Abstract Session

Hematologic Malignancies

7 June 2021

Sharman, JP

Acalabrutinib ± obinutuzumab versus obinutuzumab + chlorambucil in treatment-naïve chronic lymphocytic leukemia: Elevate-TN four-year follow up.

Abstract #7509

Poster Discussion Session

Hematologic Malignancies

4 June 2021

Sehn, L

ESCALADE: A phase 3 study of acalabrutinib in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) for patients ≤65y with untreated non-germinal center B-cell–like (non-GCB) diffuse large B-cell lymphoma (DLBCL).

Abstract #TPS7572

Poster Session

Hematologic Malignancies

4 June 2021

174 company-sponsored or supported abstracts will be presented at ASCO (Free ASCO Whitepaper) 2021.
2Beginning Friday 4 June 2021 09:00 EDT oral presentations, poster discussions and poster sessions will be available on demand for 180 days including video and slide presentations and discussant commentary.

AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

On May 19, 2021 Scenic Biotech BV ("Scenic"), a pioneer in the discovery of genetic modifiers to enable the development of disease modifying therapeutics for rare genetic disorders and other devastating illnesses, reported that it has entered into a multi-year strategic collaboration with Genentech, a member of the Roche Group, to discover, develop and commercialize novel therapeutics that target genetic modifiers (Press release, Scenic Biotech, MAY 19, 2021, View Source [SID1234580249]).

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Genetic modifiers are genes that counteract the effect of a disease-causing gene. They may explain why some people with genetic mutations linked to severe disease end up having only mild or no symptoms. Also known as disease suppressors, genetic modifiers therefore positively influence the severity of disease and act as a ‘natural form of protection’. Their discovery is leading to a completely new class of drug targets.

Under the terms of the agreement, Scenic will utilize its Cell-Seq platform and its data warehouse of genetic modifiers to identify drug targets in multiple therapeutic areas. The collaboration enables Genentech to select multiple targets for further development with an option to extend the collaboration. Scenic will receive an undisclosed upfront payment and is eligible to receive additional target selection fees for drug targets taken forward by Genentech. In addition, Scenic is eligible for success-based payments for each target based on achievement of certain predetermined milestones, as well as royalties on sales of certain products resulting from the collaboration. Total deal value could exceed US $375M.

Scenic has built an extensive proprietary data warehouse of genetic modifiers and its Cell-Seq platform enables the development of potential disease modifying therapeutics for devastating diseases with an in-house focus on inherited rare diseases and immuno-oncology/inflammation.
The Company was founded in 2017 as a spin-out of the Netherlands Cancer Institute, and Oxford University and recently appointed Oscar Izeboud, PhD as its Chief Executive Officer.

Dr Sebastian Nijman, Co-founder and CSO of Scenic Biotech said:
"Genentech is the pioneer in innovative biotech and has world leading research and development capabilities. Scenic is a science-driven company and having Genentech as our first major industry partner is a great validation of our technology and by working together it will extend the utility of our platform beyond our current therapeutic areas of interest. The collaboration also brings significant strategic value for Scenic as it enables us to realise the potential of our genetic modifier expertise alongside independently advancing our own programs towards clinical development."

On May 19, 2021 Nevada reported that Senate Finance Committee considered a $780,000 fiscal note from the Department of Health and Human Services (HHS) to fund a measure under SB380 that aims to transfer the existing state drug pricing database to the Enterprise Information Technology Services Division, where it would be managed by a pharmacist, with support from a management analyst (Press release, EVERSANA, MAY 19, 2021, View Source [SID1234580248]).

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Expanding on two bills from 2017 and 2019 that targeted price increase for diabetes and asthma drugs, respectively, SB380 would require manufacturers of all drugs, regardless of the disease they target, that exceed a $40 list prices for a course of therapy and saw a 10% increase during the previous calendar year to report certain costs and profits associated with the production of the drugs.

Further, for drugs with a list price exceeding $40 for a course of therapy, the bill would have prescription drug wholesalers report to the state minimum and maximum list prices of the drug over the last year and the aggregate amount of rebates negotiated with drug companies, manufacturers, and pharmacy benefit managers (PBMs).

The Finance Committee and HHS considered using penalties and fees collected from the diabetes and asthma programs when companies failed to meet reporting requirements; however, these funds were initially planned to go toward diabetes and asthma education programs. For SB380 sponsor Senator Julia Ratti, the use of these penalties and fees to fund management of the transparency database is a good start, but a more concrete solution is necessary.

Ratti commented, "The Department of Health and Human Services has been doing yeoman’s work to fulfill the NRS around transparency reporting…but the resources haven’t necessarily been there to do the robust analysis and the robust reporting with the data we have available. With this bill, we requested the unsolicited fiscal note to really look at, what would it cost to implement our drug transparency program in a sustainable way where we’re not taking a little bit of somebody’s time over here and a little bit of somebody’s time over there."

Learn more about Pricentric ONE and our Global Pricing Solutions!

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On May 19, 2021 Teneobio, Inc., a clinical stage biotech company focused on the discovery and development of novel multi-specific biotherapeutic antibodies, reported the publication of its bispecific human heavy chain only antibody (TNB-409) with selective IL-2βγ receptor heterodimeric agonist activity in Scientific Reports (www.nature.com/articles/s41598-021-90096-8) (Press release, TeneoBio, MAY 19, 2021, View Source;utm_medium=rss&utm_campaign=teneobio-announces-tnb-409-is-a-selective-il-2-receptor-bispecific-agonist-for-the-reatment-of-solid-tumors [SID1234580247]).

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By circumventing signaling through the α chain of the IL-2 receptor, TNB-409 minimizes Treg activation and retains robust immunostimulatory activity of T and NK cells in vitro and in vivo in monkey studies. TNB-409’s extended half-life and demonstrable safety in monkeys potentially confers a better therapeutic window for the treatment of solid tumors. TNB-409 is poised to enter phase 1 clinical studies in Q2 of 2022.

Katherine Harris, VP of Discovery at Teneobio added, "TNB-409 couples the beneficial aspects of IL-2 with Fc-mediated extended half-life, while avoiding the undesirable side effects associated with binding to IL-2Rα. TNB-409 not only achieves the desired biological activity of stimulating T and NK effector cells, moreover, it validates the applicability of Teneobio’s human single domain platform of multispecifics to target other therapeutically relevant receptor signaling pathways."

On May 19, 2021 Exscientia, the clinical stage, Artificial Intelligence (AI)-driven pharmatech company, reported that it has entered into a collaboration agreement with Bristol-Myers Squibb Company (NYSE: BMY) (Press release, Exscientia, MAY 19, 2021, View Source [SID1234580246]). This expanded collaboration has the potential to add to the Bristol Myers Squibb drug pipeline whilst enhancing Exscientia’s portfolio of shared assets. The collaboration will use AI to accelerate the discovery of small molecule therapeutic drug candidates in multiple therapeutic areas, including oncology & immunology. The agreement includes up to $50 million in upfront funding, up to $125 million in near to mid-term potential milestones, and additional clinical, regulatory and commercial payments that take the potential value of the deal beyond $1.2 billion. Exscientia will also receive tiered royalties on net sales of any marketed drug products resulting from the collaboration.

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This expanded collaboration builds upon Exscientia’s existing collaboration with Bristol Myers Squibb that was initiated in 2019 with Celgene prior to Celgene’s acquisition by Bristol Myers Squibb. Exscientia will take responsibility for AI-design and experimental work necessary to discover drug candidates associated with this collaboration for Bristol Myers Squibb. Molecules will be designed using Exscientia’s AI-driven drug discovery platform, which delivers optimized compounds fulfilling complex design goals faster and more effectively than traditional drug discovery.

Andrew Hopkins, CEO of Exscientia, commented, "We are proud that Bristol Myers Squibb wants to build on our work together with this expanded collaboration and believe it speaks to the strength and promise of Exscientia’s AI technologies and drug discovery expertise. We’re excited to work with such an experienced collaborator as Bristol Myers Squibb to develop the best possible medicines for patients."

Rupert Vessey, President of Research & Early Development at Bristol Myers Squibb said, "We have been pleased with Exscientia’s work in tackling a number of distinct projects for Bristol Myers Squibb. Exscientia’s application of AI technologies is proving capable of generating best-in-class molecules while also reducing discovery times. Rapid discovery of molecules that can enter the clinic in a timely manner could positively impact our work in discovering treatments for areas of unmet medical need"

Exscientia has already built a strong track record for its drug discovery platform, being the first company to advance AI-designed small molecule drug candidates into clinical studies. In addition to Bristol Myers Squibb, Exscientia has previously entered collaborations with major pharmaceutical companies including Bayer, Sanofi, and Dainippon Sumitomo, multiple emerging biotech companies and the Gates Foundation, demonstrating Exscientia’s reputation as the collaborator of choice for high-value AI-driven drug discovery. The company currently has more than a dozen partnered or wholly owned drugs in development. Exscientia recently secured a $525 million Series D investment, led by Softbank, to further fund expansion of its technology capabilities and proprietary drug pipeline.