On August 24, 2022 Bavarian Nordic A/S (OMX: BAVA) reported its interim financial results and business progress for the first half of 2022 and released its financial calendar for 2023 (Press release, Bavarian Nordic, AUG 24, 2022, View Source [SID1234618611]).

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Paul Chaplin, President & Chief Executive Officer of Bavarian Nordic said: "This year we planned to make significant investments for the future growth of Bavarian Nordic, as we moved two late-stage assets that have the potential to meet large unmet medical needs into global Phase 3 trials. While these programs remain on-track we have had to mobilize our entire organization to ensure we concentrate our efforts in the best possible way to manufacture and supply vaccines to help governments around the world combat an unprecedented outbreak of monkeypox. The magnitude of this outbreak was unexpected, however, our long-standing public-private partnership with the U.S. government has ensured that a safe and effective vaccine against monkeypox exists, enabling authorities to respond rapidly to this health crisis. We are making every effort to meet the initial worldwide demand for our monkeypox vaccine and are working diligently to further expand our manufacturing capacity through additional scale-up activities and partnerships.

Despite our heavy investments in R&D, the strong sales performance in all parts of our business during the first six months, together with our projections for the remainder of the year means that we are now nearing a break-even result for 2022, and we see a robust business for the monkeypox vaccine building up beyond 2022."

Financial highlights

Total revenue in first half year was DKK 857 million comprised of DKK 764 million from product sales, DKK 83 million in milestone payments from partners and DKK 10 million from contract work.
Revenue in second quarter totaled DKK 537 million comprised of DKK 234 million from sale of Rabipur/RabAvert, DKK 144 million from sale of Encepur, DKK 117 million from sale of JYNNEOS/IMVANEX/IMVAMUNE, DKK 38 million from sale of third-party products and DKK 4 million from contract work. The majority of the 2022 revenue from sale of JYNNEOS/IMVANEX/IMVANUNE during the second quarter will be recognized in the second half of 2022 in line with the planned deliveries.
EBITDA in first half year was a loss of DKK 212 million.
Strong cash position of DKK 2,753 million at end of first half year 2022
Financial guidance for the full year has been upgraded six times since March 2022 as result of multiple supply contracts being entered since the start of the monkeypox outbreak in May. The most recent guidance, issued on July 18, is maintained at revenues between DKK 2,700 and 2,900 million, EBITDA with a loss between DKK -300 and -100 million and cash and cash equivalents at year-end expected to exceed DKK 1,700 million.

DKK million Q2 2022 Q2 2021 H1 2022 H1 2021 2022 Guidance
Revenue 537 370 857 905 2,700 – 2,900
EBITDA (118) (9) (212) (8) (300) – (100)
Cash and cash equivalents 2,753* 2,207* 2,753* 2,207* > 1,700
* Repo pledged securities deducted.

Other highlights

Smallpox/Monkeypox

In May, the U.S. government exercised an option for manufacturing of freeze-dried JYNNEOS. The option, valued at USD 119 million, represents the first of a set of options with a total value of USD 299 million under a contract awarded in 2017 to convert bulk vaccine, already manufactured and invoiced under previous contracts, to freeze-dried doses.
In May, Bavarian Nordic entered several vaccine supply contracts with governments worldwide in response to the global monkeypox outbreak.
In June, Bavarian Nordic entered a multi-year contract with Canada, valued at USD 56 million, to deliver smallpox vaccines from 2023 and ahead. Bavarian Nordic has worked with the Canadian authorities since 2008 to ensure availability of the vaccine.
In June, the U.S. government ordered 500,000 doses of monkeypox vaccine for delivery in 2022. The vaccines will be filled using existing bulk vaccine already manufactured and invoiced under previous contracts.
In June, Bavarian Nordic entered a contract with the European Health Emergency Preparedness and Response Authority (HERA) to supply monkeypox vaccines to EU member states in 2022.
Respiratory Syncytial Virus (RSV)

In April, Bavarian Nordic initiated a global Phase 3 clinical trial of MVA-BN RSV against RSV in older adults. The trial is planned to enroll approximately 20,000 adults ≥60 years of age and will run through the RSV season 2022/2023 with topline results expected mid-2023.
In June, the European Medicines Agency granted access to its priority medicines (PRIME) scheme for MVA-BN RSV in active immunization for the prevention of lower respiratory tract disease caused by RSV in adults ≥60 years of age. MVA-BN RSV has previously also been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA).
ABNCoV2 (COVID-19)

In May, Bavarian Nordic reported additional Phase 2 results for the COVID-19 booster vaccine candidate, ABNCoV2, demonstrating that vaccination with ABNCoV2 induced a significant boost to the neutralizing antibodies against the Omicron variant in the majority of subjects (87%), who were previously vaccinated with approved mRNA or adenoviral vaccines. Neutralizing antibodies reached levels reported to be associated with a high level of protection (>90%), similar to what was previously reported for ABNCoV2 with respect to other variants of concern.
In June, Bavarian Nordic announced an updated design for its Phase 3 trial for ABNCoV2, which will be a non-inferiority trial comparing ABNCoV2 to Comirnaty. The trial will start enrollment in August 2022.
Events after the reporting date

In July, the U.S. government ordered an additional 5 million doses of monkeypox vaccine for delivery in 2022 and 2023. The vaccines will be filled using existing bulk vaccine, earlier manufactured and invoiced under previous contracts with the U.S. government. A U.S. based contract manufacturer will assist in the filling of vaccines.
In July, following a positive opinion by the Committee for Medicinal Products for Human Use (CHMP), the European Commission approved an extension of the current marketing authorization for the Company’s smallpox vaccine, IMVANEX to include protection from monkeypox and disease caused by vaccinia virus.
In July, Bavarian Nordic received approvals from U.S. and EU regulatory authorities of the final drug manufacturing of smallpox and monkeypox vaccine, which has been transferred to the Company’s fill and finish facility in Denmark. The U.S. approval was granted after a successful inspection by FDA earlier in July and the EU approval was granted upon assessment by CHMP of an application submitted in June 2022, in supplement to the approval earlier granted by the Danish Medicines Agency after inspection of the facility.
In July and August, Bavarian Nordic received additional orders for monkeypox vaccine from several governments, including significant orders for 2023.
Conference call and webcast
The management of Bavarian Nordic will host an investor/analyst call today at 2 pm CEST (8 am EDT) to present the interim results followed by a Q&A session. A listen-only version of the call and presentation slides can be accessed via https://bit.ly/3pBUllR. To join the Q&A session, please register in advance via https://bit.ly/3dS5ZGU.

On August 24, 2022 EDAP TMS SA (Nasdaq: EDAP) (the "Company"), a global leader in robotic energy-based therapies, reported that unaudited financial results for the second quarter 2022 (Press release, EDAP TMS, AUG 24, 2022, View Source [SID1234618666]).

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Marc Oczachowski, EDAP’s Chairman and Chief Executive Officer, said: "For the second quarter 2022, we generated strong year-over-year revenue growth of nearly 37% driven by contribution from all three business segments, including our core HIFU business, which grew nearly 50% over the prior year period. The measured investments that we continue to make in our US team and infrastructure continue to bear fruit as HIFU, and specifically Focal One, becomes integral to the modern prostate cancer treatment paradigm."

"Our pipeline of sales prospects continues to grow, driven by a combination of new world-renowned healthcare institutions that have adopted Focal One, and champion this technology, and our growing presence at important medical meetings such as the annual meeting of the American Urological Association this past May. These trends, together with the proposed increase in reimbursement for CY23 indicated in the preliminary CMS Outpatient Prospective Payment System (OPPS) rule, give me great optimism for the future adoption of our Focal One platform." Mr. Oczachowski concluded.

Ryan Rhodes, Chief Executive Officer of EDAP US, stated, "Following the close of the second quarter, we learned that the Centers for Medicare and Medicaid Services, in its proposed OPPS rule for calendar year 2023, raised Focal One HIFU reimbursement to APC Level 6 from Level 5 currently. It is difficult to overstate the positive impact such a change would have on expanding patient procedure access should the increase stand in the final rule, which we expect to be published in November. We are very pleased with this proposed increase to hospital reimbursement and believe it more accurately reflects the significant clinical value that HIFU brings to the urology suite."

"We also will be hosting an in-person Focal One Expert User Panel Event in New York City in September, to coincide with Prostate Cancer Awareness Month. The event will feature presentations from several renowned thought leaders and will also include a demonstration of the Focal One procedure."

Year-to-Date Results

Total revenue for the six months ended June 30, 2022, was EUR 27.1 million (USD 29.5 million), an increase of 31.5% from total revenue of was EUR 20.7 million (USD 24.8 million) for the same period in 2021.

Total revenue in the HIFU business for the six months ended June 30, 2022, was EUR 6.8 million (USD 7.4 million), an increase of 78.8% as compared to EUR 3.8 million (USD 4.6 million) for the six months ended June 30, 2021.

Total revenue in the LITHO business for the six months ended June 30, 2022, was EUR 5.8 million (USD 6.3 million), an increase of 11.6% from EUR 5.2 million (USD 6.2 million) for the six months ended June 30, 2021.

Total revenue in the Distribution business for the six months ended June 30, 2022, was EUR 14.6 million (USD 15.9 million), a 24.8% increase compared to EUR 11.7 million (USD 14.0 million) for the six months ended June 30, 2021.

Gross profit for the six months ended June 30, 2022, was EUR 12.0 million (USD 13.0 million), compared to EUR 8.6 million (USD 10.3 million) for the year-ago period. Gross profit margin on net sales was 44.0% for the six months ended June 30, 2022, compared to 41.6% for the comparable period in 2021. The increase in gross profit year-over-year was due to higher sales effect on fixed costs, particularly in the HIFU business.

Operating expenses were EUR 12.5 million (USD 13.6 million) for the six months ended June 30, 2022, compared to EUR 8.8 million (USD 10.5 million) for the same period in 2021.

Operating loss for the six months ended June 30, 2022, was EUR 0.5 million (USD 0.6 million), compared to an operating loss of EUR 0.2 million (USD 0.2 million) for the six months ended June 30, 2021.

Net income for the six months ended June 30, 2022, was EUR 2.2 million (USD 2.4 million), or EUR 0.06 per diluted share, as compared to a net income of EUR 0.4 million (USD 0.4 million), or EUR 0.01 per diluted share in the year-ago period.

As of June 30, 2022, the company held cash and cash equivalents of EUR 46.3 million (USD 48.5 million), as compared to EUR 47.2 million (USD 53.4 million) as of December 31, 2021.

Second Quarter 2022 Results

Total revenue for the second quarter 2022 was EUR 14.2 million (USD 15.0 million), a 36.7% increase as compared to total revenue of EUR 10.4 million (USD 12.4 million) for the same period in 2021.

Total revenue in the HIFU business for the second quarter 2022 was EUR 3.0 million (USD 3.2 million), an increase of 49.3% as compared to EUR 2.0 million (USD 2.4 million) for the second quarter of 2021.

Total revenue in the LITHO business for the second quarter 2022 was EUR 3.6 million (USD 3.8 million), an increase of 55.7% from was EUR 2.3 million (USD 2.7 million) for the second quarter of 2021.

Total revenue in the Distribution business for the second quarter 2022 was EUR 7.6 million (USD 8.1 million), a 25.5% increase compared to EUR 6.1 million (USD 7.3 million) for the second quarter of 2021.

Gross profit for the second quarter 2022 was EUR 6.2 million (USD 6.6 million), compared to EUR 4.2 million (USD 5.1 million) for the year-ago period. Gross profit margin on net sales was 43.8% in the second quarter of 2022, compared to 40.7% in the year-ago period. The increase in gross profit year-over-year was driven by the higher sales effect on fixed costs.

Operating expenses were EUR 6.6 million (USD 7.0 million) for the second quarter of 2022, compared to EUR 4.6 million (USD 5.6 million) for the same period in 2021.

Operating loss for the second quarter of 2022 was EUR 0.4 million (USD 0.5 million), compared to an operating loss of EUR 0.4 million (USD 0.5 million) in the second quarter of 2021.

Net income for the second quarter of 2022 was EUR 1.8 million (USD 1.9 million), or EUR 0.05 per diluted share, as compared to a net loss of EUR 0.4 million (USD 0.5 million), or EUR 0.01 per diluted share in the year-ago period.

In-person Focal One Expert User Panel Event
The management team of EDAP will host a In-person Focal One Expert User Panel Event in New York City on Thursday, September 29. View Source

Conference Call

An accompanying conference call and webcast will be conducted by management to review the results. The call will be held at 8:30am EDT tomorrow, August 25, 2022. Please refer to the information below for conference call dial-in information and webcast registration.

On August 24, 2022 AstraZeneca reported that it will present new data supporting its ambition to redefine cancer care at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2022, 9 to 13 September 2022 (Press release, AstraZeneca, AUG 24, 2022, View Source [SID1234618612]).

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A total of 15 approved and potential new medicines from AstraZeneca will be featured across more than 75 abstracts in 13 tumour types.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: "At ESMO (Free ESMO Whitepaper) this year, new evidence will demonstrate how our medicines are prolonging patient survival across several cancers. Data from the SOLO-1 and PAOLA-1 Phase III trials will reinforce the long-term survival benefits of PARP inhibition with Lynparza in advanced ovarian cancer, and new data for Imfinzi combinations in liver, biliary tract and lung cancers will show the potential to improve outcomes for patients in these areas of high unmet need."

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "The momentum will continue for Enhertu at ESMO (Free ESMO Whitepaper) with new data across tumour types, including results from the DESTINY-Lung02 Phase II trial in HER2-mutant metastatic non-small cell lung cancer which formed the basis for the recent FDA approval. Additionally, we’re excited to advance the science of CTLA-4 inhibition with new analyses presented from two Phase III trials of Imfinzi plus tremelimumab, HIMALAYA in liver cancer and POSEIDON in lung cancer, and for MEDI5752, our bispecific antibody targeting both PD-1 and CTLA-4 in lung cancer."

Transforming outcomes across tumours over time
Mature disease-free survival (DFS) data from the ADAURA Phase III trial will be featured in a late-breaking presentation detailing two years of additional follow-up in patients with early-stage (Stage IB-IIIA) EGFR-mutated non-small cell lung cancer (NSCLC) treated with adjuvant Tagrisso (osimertinib). Tagrisso is the only targeted treatment option approved in this setting. The presentation will also report updated results for patterns of recurrence and central nervous system DFS.

A late-breaking presentation will feature landmark five-year overall survival (OS) data from the externally sponsored PAOLA-1 Phase III trial of Lynparza (olaparib) in combination with bevacizumab in 1st-line advanced ovarian cancer, including patients with homologous recombination deficiency (HRD) positive disease. This is the longest follow up for a PARP inhibitor in combination with standard of care in this setting.

In addition, seven-year OS data from the SOLO1 Phase III trial of Lynparza for 1st-line maintenance therapy in BRCA-mutated (BRCAm) advanced ovarian cancer will be presented. This is the longest follow-up for any PARP inhibitor in newly diagnosed advanced ovarian cancer.

Data will also include updated OS results at two years from the TOPAZ-1 Phase III trial of Imfinzi (durvalumab) plus standard-of-care chemotherapy (gemcitabine plus cisplatin) in 1st-line unresectable or advanced biliary tract cancer, as well as an analysis of immune-mediated adverse events. TOPAZ-1 is the first Phase III trial to show improved OS with an immunotherapy combination versus chemotherapy alone in this setting.

Extending the benefit of antibody drug conjugates (ADCs) to more patients
Several presentations will demonstrate the clinical potential of Enhertu (trastuzumab deruxtecan) treatment across HER2-targetable lung, gastric and breast cancers.

A late-breaking presentation will feature interim results from the DESTINY-Lung02 Phase II trial investigating Enhertu in patients with HER2-mutant (HER2m) metastatic NSCLC (mNSCLC) who have progressed following one or more systemic therapies. Enhertu was recently approved in the US in this setting as the first HER2-directed treatment for these patients. Detailed data will also be shared from the DESTINY-Lung01 Phase II trial, both in this setting and in patients with HER2-overexpressing mNSCLC.

Another presentation will feature updated data from the DESTINY-Gastric02 Phase II trial in HER2-positive metastatic gastric cancer, the first Enhertu trial in Western patients with gastric cancer.

Data will also include a subgroup analysis of the DESTINY-Breast03 Phase III trial of Enhertu by disease history and prior treatments in patients with HER2-positive metastatic breast cancer previously treated with trastuzumab and a taxane. Patient-reported outcomes from the DESTINY-Breast04 Phase III trial will also highlight quality of life data for patients treated with Enhertu in HER2-low unresectable and/or metastatic breast cancer. Enhertu was recently approved in the US as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer based on this trial.

Additional posters will describe trials evaluating the TROP2-directed ADC datopotamab deruxtecan in patients with hormone-receptor positive, HER2-negative breast cancer (TROPION-Breast01 Phase III trial) and in a platform trial in combination with Tagrisso in patients with advanced NSCLC who have experienced disease progression (ORCHARD Phase II trial). There are currently no approved TROP2-directed therapies for patients in these settings.

Advancing the science of CTLA-4 inhibition
A new analysis from the positive HIMALAYA Phase III trial will show the impact of viral aetiology on outcomes in unresectable liver cancer for patients treated with a single priming dose of tremelimumab, an anti-CTLA-4 antibody, added to Imfinzi (STRIDE regimen).

In addition, a poster will describe the EMERALD-3 Phase III trial evaluating tremelimumab added to Imfinzi and transarterial chemoembolisation with or without lenvatinib in unresectable liver cancer patients eligible for embolisation.

A late-breaking presentation of the positive POSEIDON Phase III trial in mNSCLC will feature four-year OS outcomes in patients treated with a limited course of tremelimumab added to Imfinzi plus chemotherapy.

Another late-breaking presentation will share initial data for MEDI5752 plus chemotherapy in patients with treatment-naïve Stage IIIB-IV non-squamous NSCLC. MEDI5752 is a novel bispecific antibody that simultaneously targets the immune checkpoint proteins PD-1 and CTLA-4. Bispecific antibodies are a promising approach in immuno-oncology that combines the potential benefits of two medicines into one antibody without the increased toxicity seen with administration of two separate medicines.

Reinforcing the robust benefits of PARP inhibitors across a broad range of tumour types
In addition to data from PAOLA-1 and SOLO1, an oral presentation will share updated efficacy analyses across biomarker subgroups from the PROpel Phase III trial of Lynparza plus abiraterone in patients with newly diagnosed metastatic castration-resistant prostate cancer (mCRPC) treated with the combination with or without homologous recombination repair (HRR) gene mutations. Lynparza is the first PARP inhibitor to demonstrate a significant improvement in radiographic progression-free survival in combination with abiraterone versus abiraterone alone in 1st-line mCRPC irrespective of biomarker status.

Additionally, final OS data will be presented from the MEDIOLA Phase II trial of Lynparza and Imfinzi in germline BRCAm platinum-sensitive relapsed ovarian cancer and from the OPINION Phase IIIB trial of Lynparza maintenance monotherapy in patients with platinum-sensitive relapsed ovarian cancer without a germline BRCA1/BRCA2 mutation.

Data will also include an extended OS analysis from the POLO Phase III trial of Lynparza in germline BRCA-mutated metastatic pancreatic cancer, a disease in which no other PARP inhibitor is approved.

Collaboration in the scientific community is critical to improving outcomes for patients. AstraZeneca is collaborating with Daiichi Sankyo Company Limited to develop and commercialise Enhertu and datopotamab deruxtecan, and with MSD (Merck & Co., Inc. in the US and Canada) to develop and commercialise Lynparza.

Key AstraZeneca presentations during ESMO (Free ESMO Whitepaper) 2022

Lead author

Abstract title

Presentation details

Antibody drug conjugates
Goto, K

Trastuzumab Deruxtecan (T-DXd) in Patients (Pts) With HER2-Mutant Metastatic Non-Small Cell Lung Cancer (NSCLC): Interim Results From the Phase 2 DESTINY-Lung02 Trial

Presentation #LBA55

Mini Oral Session

11 September 2022

10:15am (CEST)

Ueno, NT

Patient-Reported Outcomes (PROs) From DESTINY-Breast04, a Randomized Phase 3 Study of Trastuzumab Deruxtecan (T-DXd) vs Treatment of Physician’s Choice (TPC) in Patients (pts) With HER2-Low Metastatic Breast Cancer (MBC)

Presentation #217O

Proffered Paper Session

11 September 2022

9:30am (CEST)

Ku, GY

Updated Analysis of DESTINY-Gastric02: a Phase 2 Single-Arm Trial of Trastuzumab Deruxtecan (T-DXd) in Western Patients (Pts) With HER2-Positive (HER2+) Unresectable/Metastatic Gastric/Gastroesophageal Junction (GEJ) Cancer Who Progressed on or After Trastuzumab-Containing Regimen

Presentation #1205MO

Mini Oral Session

10 September 2022

3:45pm (CEST)

Cortés, J

Subgroup Analysis by Disease History and Prior Treatments of Patients (pts) With HER2-Positive (HER2+) Metastatic Breast Cancer (MBC) From DESTINY-Breast03, a Randomized Phase 3 Study of Trastuzumab Deruxtecan (T-DXd) vs Trastuzumab Emtansine (T-DM1)

Presentation #236P

e-Poster

10 September 2022

Li, BT

Phase 2 Trial of Trastuzumab Deruxtecan (T-DXd) in Patients (Pts) With HER2-Mutated (HER2m) Metastatic Non-Small Cell Lung Cancer (NSCLC): Registrational Data From DESTINY-Lung01

Presentation #976P

e-Poster

12 September 2022

Bardia, A

Datopotamab deruxtecan (Dato-DXd), a TROP2 antibody-drug conjugate, vs investigators’ choice of chemotherapy (ICC) in previously-treated, inoperable or metastatic hormone-receptor (HR) positive, HER2-negative (HR+/HER2–) breast cancer: TROPION-Breast01

Presentation #274TiP

Trial in Progress

10 September 2022

De Langen, J

ORCHARD platform study: osimertinib + datopotamab deruxtecan (Dato-DXd) cohort in patients (pts) with advanced NSCLC (aNSCLC) who have progressed on first-line (1L) osimertinib

Presentation #1188TiP

Trial in Progress

12 September 2022

Immuno-oncology
Johnson, ML.

Durvalumab (D) ± tremelimumab (T) + chemotherapy (CT) in 1L metastatic (m) NSCLC: overall survival (OS) update from POSEIDON after median follow-up (mFU) of approximately 4 years (y)

Presentation #LBA59

Mini Oral Session

11 September 2022

11:05am (CEST)

Ahn, MJ

MEDI5752 or pembrolizumab (P) plus carboplatin/pemetrexed (CP) in treatment-naïve (1L) non-small cell lung cancer (NSCLC): a Phase 1b/2 trial

Presentation #LBA56

Mini Oral Session

11 September 2022

10:20am (CEST)

Spicer, J

Platform study of neoadjuvant durvalumab (D) alone or combined with novel agents in patients (pts) with resectable, early-stage non-small-cell lung cancer (NSCLC): pharmacodynamic correlates and circulating tumor DNA (ctDNA) dynamics in the NeoCOAST study

Presentation #929MO

Mini Oral Session

12 September 2022

3:15pm (CEST)

Oh, DY

Updated overall survival (OS) from the Phase 3 TOPAZ-1 study of durvalumab (D) or placebo (PBO) plus gemcitabine and cisplatin (+ GC) in patients (pts) with advanced biliary tract cancer (BTC)

Presentation #56P

e-Poster

12 September 2022

Antonuzzo, L

Immune-mediated adverse event (imAE) incidence, timing and association with efficacy in the Phase 3 TOPAZ-1 study of durvalumab (D) or placebo (PBO) plus gemcitabine and cisplatin (+ GC) in advanced biliary tract cancer (BTC)

Presentation #57P

e-Poster

12 September 2022

Chan, LS

Impact of viral aetiology in the Phase 3 HIMALAYA study of tremelimumab (T) plus durvalumab (D) in unresectable hepatocellular carcinoma (uHCC)

Presentation #714P

e-Poster

12 September 2022

Özgüroğlu, M

Phase 3 trial of durvalumab combined with domvanalimab following concurrent chemoradiotherapy (cCRT) in patients with unresectable stage III NSCLC (PACIFIC-8)

Presentation #971TiP

Trial in Progress

10 September 2022

Abou-Alfa, GK

A randomised Phase 3 study of tremelimumab (T) plus durvalumab (D) with or without lenvatinib combined with concurrent transarterial chemoembolisation (TACE) versus TACE alone in patients (pts) with locoregional hepatocellular carcinoma (HCC): EMERALD-3

Presentation #727TiP

Trial in Progress

12 September 2022

DNA damage response
Ray-Coquard, IL

Final overall survival (OS) results from the Phase III PAOLA-1/ENGOT-ov25 trial evaluating maintenance olaparib (ola) plus bevacizumab (bev) in patients (pts) with newly diagnosed advanced ovarian cancer (AOC)

Presentation #LBA29

Proffered Paper Session

9 September 2022

2:00pm (CEST)

DiSilvestro, P

Overall survival (OS) at 7-year (y) follow-up (f/u) in patients (pts) with newly diagnosed advanced ovarian cancer (OC) and a BRCA mutation (BRCAm) who received maintenance olaparib in the SOLO1/GOG-3004 trial

Presentation #517O

Proffered Paper Session

9 September 2022

2:10pm (CEST)

Guo, C

A Phase (Ph) I/II trial of the CXCR2 antagonist AZD5069 in combination with enzalutamide (ENZA) in patients (pts) with metastatic castration resistant prostate cancer (mCRPC)

Presentation #454O

Proffered Paper Session

10 September 2022

11:15am (CEST)

Saad, F

Biomarker analysis and updated results from the Phase III PROpel trial of abiraterone (abi) and olaparib (ola) vs abi and placebo (pbo) as first-line (1L) therapy for patients (pts) with metastatic castration-resistant prostate cancer (mCRPC)

Presentation #1357O

Proffered Paper Session

11 September 2022

9:30am (CEST)

Banerjee, S

Phase II study of olaparib plus durvalumab with or without bevacizumab (MEDIOLA): final analysis of overall survival in patients with non-germline BRCA-mutated platinum-sensitive relapsed ovarian cancer

Presentation #529MO

Mini Oral Session

11 September 2022

5:00pm (CEST)

Poveda Velasco, AM

Maintenance olaparib monotherapy in patients (pts) with platinum-sensitive relapsed ovarian cancer (PSR OC) without a germline BRCA1/BRCA2 mutation (non-gBRCAm): final overall survival (OS) results from the OPINION trial

Presentation #531P

e-Poster

11 September 2022

Hammel, P

Extended overall survival results from the POLO study of active maintenance olaparib in patients with metastatic pancreatic cancer and a germline BRCA mutation

Presentation #1298P

e-Poster

12 September 2022

Tumour drivers and resistance
Tsuboi, M

Osimertinib as adjuvant therapy in patients (pts) with resected EGFR-mutated (EGFRm) stage IB–IIIA non-small cell lung cancer (NSCLC): updated results from ADAURA

Presentation #LBA47

Proffered Paper Session

11 September 2022

8:30am (CEST)

Piotrowska, Z

ELIOS: A multicentre, molecular profiling study of patients (pts) with epidermal growth factor receptor-mutated (EGFRm) advanced NSCLC treated with first-line (1L) osimertinib

Presentation #LBA53

Proffered Paper Session

11 September 2022

3:05pm (CEST)

Nakamura, A

Final results and biomarker analysis of a randomized phase II study of osimertinib plus bevacizumab versus osimertinib monotherapy for untreated patients with non-squamous non-small-cell lung cancer harboring EGFR mutations; WJOG9717L study

Presentation #982P

e-Poster

12 September 2022

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 August 24, 2022 Bavarian Nordic A/S (OMX: BAVA) reported an agreement with the Pan American Health Organization (PAHO) to facilitate equitable access to the Company’s monkeypox vaccine for countries in Latin America and the Caribbean (Press release, Bavarian Nordic, AUG 24, 2022, View Source,Latin%20America%20and%20the%20Caribbean. [SID1234618613]). Deliveries of the vaccines are expected to begin in September .

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The vaccines will be made available to those countries that participate in PAHO’s Revolving Fund for Access to Vaccines – a technical cooperation mechanism established more than 40 years ago to support national immunization programs, pooling resources from participating PAHO member countries across the Americas to procure vaccines and related supplies.

Paul Chaplin, President and CEO of Bavarian Nordic said: "Monkeypox is a global health challenge that has prompted health authorities worldwide to respond, and we are pleased to work with PAHO to ensure access to vaccines for its member states in the Americas. With the agreement, we have now helped to secure access to our vaccine in more than 70 countries globally, representing the vast majority of affected regions outside endemic areas. While the global supply is currently limited, we are working diligently to increase our manufacturing capacity and have taken steps to partner with other companies to rapidly produce more vaccines to help combat the outbreak."

Bavarian Nordic maintains its guidance for 2022 as this order has already been included in the upgraded financial expectations, as communicated on July 18, 2022.

On August 24, 2022 Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, reported that data on the efficacy and tolerability of investigational new drug AL102 from Part A of the Phase 2/3 RINGSIDE study will be presented in an oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, to take place September 8-13, 2022 in Paris, France (Press release, Ayala Pharmaceuticals, AUG 24, 2022, View Source [SID1234618596]).

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The presentation details follow:

Abstract Title: Initial Results of Phase 2/3 Trial of AL102 for Treatment of Desmoid Tumors (DT)
Presentation Number: 1488MO
Session Type: Mini Oral Session
Session Title: Sarcoma
Session Date and Time: Monday, September 12, 2022, at 2:45 pm CEST / 8:45 am EDT
About the RINGSIDE study
The RINGSIDE pivotal Phase 2/3 study is a randomized multi-center trial. Part A of the study is evaluating the efficacy, safety, tolerability, and tumor volume by MRI after 16 weeks of AL102 in adult patients with desmoid tumors. It enrolled 42 patients and is evaluating 3 doses of AL102. Patients who participated in Part A will be eligible to enroll into an open-label extension study at the selected Part B dose, and long-term efficacy and safety will be monitored. Part B of the study will be double-blind, placebo-controlled, and will start immediately after dose selection from part A, enrolling up to 156 adult and adolescent patients with progressive disease, randomized between AL102 or placebo. The study’s primary endpoint is progression-free survival (PFS) with secondary endpoints including objective response rate (ORR), duration of response (DOR), and patient-reported Quality of Life (QOL) measures.

For more information on the RINGSIDE Phase 2/3 study with AL102 for the treatment of desmoid tumors, please visit ClinicalTrials.gov and reference Identifier NCT04871282 (RINGSIDE).

About Desmoid Tumors
Desmoid tumors also called aggressive fibromatosis or desmoid-type fibromatosis, are rare connective tissue tumors that typically arise in the upper and lower extremities, abdominal wall, head and neck area, mesenteric root, and chest wall with the potential to arise in additional parts of the body. Desmoid tumors do not metastasize, but often aggressively infiltrate neurovascular structures and vital organs. People living with desmoid tumors are often limited in their daily life due to chronic pain, functional deficits, general decrease in their quality of life and organ dysfunction. Desmoid tumors have an annual incidence of approximately 1,700 patients in the United States and typically occur in patients between the ages of 15 and 60 years. They are most commonly diagnosed in young adults between 30-40 years of age and are more prevalent in females. Today, surgery is no longer regarded as the cornerstone treatment of desmoid tumors due to high rate of recurrence post-surgery and there are currently no FDA-approved systemic therapies for the treatment of unresectable, recurrent or progressive desmoid tumors.