LYNPARZA is the first targeted medicine to show clinical benefit in the adjuvant setting for patients with germline BRCA-mutated high-risk HER2-negative early breast cancer
CALQUENCE shows sustained four-year clinical benefit in 1st-line chronic lymphocytic leukemia and lower atrial fibrillation rates in previously treated patients vs. ibrutinib
IMFINZI five-year data represent longest-ever survival reported in a Phase III immunotherapy trial in unresectable Stage III lung cancer
WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca will present new data underscoring its ambition to redefine cancer care at the American Society of Clinical Oncology (ASCO) Annual Meeting, June 4 to 8, 2021.
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 this year show our unwavering resolve to revolutionize cancer care and strengthen our leading portfolio in lung and breast cancers as well as hematology. New results for LYNPARZA® (olaparib) and IMFINZI® (durvalumab) 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 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 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 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® (acalabrutinib) monotherapy or CALQUENCE in combination with obinutuzumab, providing flexibility to tailor treatment for adults with treatment-naïve chronic lymphocytic leukemia (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 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 (TKIs) in CLL, confirming the favorable 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 (fam-trastuzumab deruxtecan-nxki) 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-tumor 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 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 program
In all, AstraZeneca will share 18 posters at ASCO 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 IMFINZIin 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 estrogen receptor degrader (SERD), plus palbociclib, versus anastrozole plus palbociclib, in patients with estrogen receptor-positive, HER2-negative advanced breast cancer who have not previously received systemic treatment for advanced disease
- Adavosertib – the ADAGIO Phase II multicenter 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 commercialized in collaboration with Merck & Co., Inc. AstraZeneca is collaborating with Daiichi Sankyo Company, Limited (Daiichi Sankyo) to develop and commercialize ENHERTU and datopotamab deruxtecan globally.
Key AstraZeneca presentations during the 2021 ASCO Annual Meeting1
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Lead author |
Abstract title |
Presentation details2 |
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Immuno-Oncology |
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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 June 4, 2021 |
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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 June 4, 2021 |
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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 June 4, 2021 |
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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).
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Abstract #1023 Poster Discussion Session Breast Cancer—Metastatic June 4, 2021 |
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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).
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Abstract #TPS1105 Poster Session Breast Cancer—Metastatic June 4, 2021 |
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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.
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Abstract #9514 Poster Discussion Session Melanoma/Skin Cancers June 4, 2021 |
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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 June 4, 2021 |
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Tumor drivers and resistance |
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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 June 4, 2021 |
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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.
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Abstract #TPS1101 Poster Session Breast Cancer—Metastatic June 4, 2021 |
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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 June 6, 2021 |
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Antibody drug conjugates |
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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).
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Abstract #TPS9127 Poster Session Lung Cancer – Non-small Cell Metastatic June 4, 2021 |
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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).
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Abstract #TPS1096 Poster Session Breast Cancer—Metastatic June 4, 2021 |
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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 June 4, 2021 |
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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).
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Abstract #3505 Oral Abstract Session Gastrointestinal Cancer—Colorectal and Anal June 7, 2021 |
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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 June 4, 2021 |
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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 June 4, 2021 |
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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).
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Abstract #4048 Poster Session Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary June 4, 2021 |
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DNA damage response |
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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.
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Abstract #LBA1 Plenary Session June 6, 2021, 1:00pm EDT
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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 June 4, 2021 |
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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.
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Abstract #5545 Poster Session Gynecologic Cancer June 4, 2021 |
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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.
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Abstract #5515 Poster Discussion Session Gynecologic Cancer June 4, 2021 |
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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.
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Abstract #5514 Poster Discussion Session Gynecologic Cancer June 4, 2021 |
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Hematology |
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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 June 7, 2021 |
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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 June 4, 2021 |
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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).
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Abstract #TPS7572 Poster Session Hematologic Malignancies June 4, 2021
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174 company-sponsored or supported abstracts will be presented at ASCO 2021. |
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2Beginning Friday,June 4, 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. |
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SELECT SAFETY INFORMATION for LYNPARZA® (olaparib) tablets
LYNPARZA is associated with serious, potentially fatal risks, including myelodysplastic syndrome/acute myeloid leukemia (MDS/AML), pneumonitis. Additionally, serious, potentially fatal risk of venous thromboembolic events has been reported with LYNPARZA in mCRPC. LYNPARZA can also cause fetal harm.
U.S. FDA-APPROVED INDICATIONS
LYNPARZA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:
First-Line Maintenance BRCAm Advanced Ovarian Cancer
For the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.
First-Line Maintenance HRD Positive Advanced Ovarian Cancer in Combination with Bevacizumab
In combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either:
- a deleterious or suspected deleterious BRCA mutation, and/or
- genomic instability
Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.
Maintenance Recurrent Ovarian Cancer
For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in complete or partial response to platinum-based chemotherapy.
Advanced gBRCAm Ovarian Cancer
For the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) advanced ovarian cancer who have been treated with 3 or more prior lines of chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.
gBRCAm, HER2-Negative Metastatic Breast Cancer
For the treatment of adult patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant, or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine therapy. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.
First-Line Maintenance gBRCAm Metastatic Pancreatic Cancer
For the maintenance treatment of adult patients with deleterious or suspected deleterious gBRCAm metastatic pancreatic adenocarcinoma whose disease has not progressed on at least 16 weeks of a first-line platinum-based chemotherapy regimen. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.
HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer
For the treatment of adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC) who have progressed following prior treatment with enzalutamide or abiraterone. Select patients for therapy based on an FDA-approved companion diagnostic for LYNPARZA.
Please click here for complete Prescribing Information, including Patient Information (Medication Guide).
SELECT SAFETY INFORMATION FOR IMFINZI® (durvalumab)
Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue, including the following: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated dermatologic adverse reactions, immune-mediated nephritis and renal dysfunction, and solid organ transplant rejection. IMFINZI can cause severe or life-threatening infusion-related reactions. Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1/PD-L1 blocking antibody.
Advise women not to become pregnant or breastfeed during treatment with IMFINZI and for at least 3 months after the last dose.
In the PACIFIC trial, the most frequent serious adverse reactions reported in at least 2% of patients were pneumonitis or radiation pneumonitis (7%) and pneumonia (6%).
The most common adverse reactions were cough, fatigue, pneumonitis or radiation pneumonitis, upper respiratory tract infections, dyspnea, and rash.
The safety and effectiveness of IMFINZI have not been established in pediatric patients.
Please click here for complete Prescribing Information, including Patient Information.
SELECT SAFETY INFORMATION FOR CALQUENCE® (acalabrutinib)
INDICATION AND USAGE
CALQUENCE is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
SELECT SAFETY INFORMATION
Serious adverse events, including fatal events, have occurred with CALQUENCE, including serious and opportunistic infections, hemorrhage, cytopenias, second primary malignancies, and atrial fibrillation and flutter. The most common adverse reactions (≥ 30%) of any grade in patients with CLL were anemia, neutropenia, thrombocytopenia, headache, upper respiratory tract infection, and diarrhea.
Please see full Prescribing Information including Patient Information.
SELECT SAFETY INFORMATION FOR TAGRISSO® (osimertinib)
- There are no contraindications for TAGRISSO
- TAGRISSO is associated with several serious and sometimes fatal adverse reactions, including interstitial lung disease/pneumonitis, QTc interval prolongation, cardiomyopathy, keratitis, erythema multiforme and Stevens-Johnson syndrome, and embryo-fetal toxicity
- The most common adverse reactions (≥20%) were diarrhea, rash, dry skin, nail toxicity, stomatitis, fatigue, and decreased appetite
U.S. FDA-APPROVED INDICATIONS
- TAGRISSO is indicated for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test
- TAGRISSO is indicated for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy
Please see complete Prescribing Information, including Patient Information.
IMPORTANT SAFETY INFORMATION FOR ENHERTU® (fam-trastuzumab deruxtecan-nxki)
Indications
ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with:
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Unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.
This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
- Locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.
Contacts
Michele Meixell +1 302 885 2677
Brendan McEvoy +1 302 885 2677