On December 10, 2021 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) reported a positive interim safety update from the investigator-sponsored, phase 2 IRENE trial in a poster presentation at the 2021 San Antonio Breast Cancer Symposium (SABCS) (Press release, Oncolytics Biotech, DEC 10, 2021, View Source [SID1234596760]).

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The IRENE trial is designed to evaluate the safety and efficacy of pelareorep in combination with Incyte’s anti-PD-1 checkpoint inhibitor retifanlimab for second- or third-line treatment of patients with metastatic triple-negative breast cancer (TNBC). Safety data from the trial show that the combination has been well-tolerated, as no safety concerns have been noted in any of the five patients enrolled in the trial at the time of reporting. The trial remains ongoing and will continue to enroll patients at the Rutgers Cancer Institute of New Jersey and the Ohio State University Comprehensive Cancer Center.

Mridula George, M.D., Medical Oncologist, Rutgers Cancer Institute of New Jersey, Assistant Professor of Medicine, Rutgers Robert Wood Johnson Medical School, and principal investigator of the trial commented, "Checkpoint inhibitors benefit only a minority of TNBC patients due to immunosuppressive tumor microenvironments (TMEs) and poor PD-L1 expression. Prior clinical studies have shown that pelareorep upregulates tumor PD-L1 expression and reverses immunosuppressive TMEs. These findings suggest that pelareorep can address a pressing unmet need in TNBC by synergizing with PD-1 inhibition to increase the proportion of patients responding to therapy. We look forward to evaluating this hypothesis through the IRENE study’s continued advancement and are pleased that the pelareorep-retifanlimab combination has been well-tolerated in each of the patients enrolled in the trial."

In addition to evaluating the safety and efficacy of pelareorep plus retifanlimab, IRENE is also designed to assess changes in PD-L1 expression and correlations between treatment outcomes and changes in peripheral blood T cell populations. This could provide a potential biomarker of pelareorep response that may enable the success of future registrational trials by allowing for the early identification of patients most likely to respond to therapy.

A copy of the SABCS poster titled, "IRENE study: Phase 2 study of Retifanlimab and the oncolytic virus pelareorep in metastatic triple negative breast cancer," will be available on the Posters & Publications page of Oncolytics’ website (LINK) following the conclusion of the symposium.

About IRENE
The IRENE (INCMGA00012 and the oncolytic virus pelareorep in metastatic triple-negative breast cancer) study is a single-arm, open-label, phase 2 study evaluating the combination of pelareorep and Incyte’s anti-PD-1 checkpoint inhibitor retifanlimab (INCMGA00012) for the second- or third-line treatment of unresectable locally advanced or metastatic triple-negative breast cancer. The study will enroll 25 patients and is being conducted at the Rutgers Cancer Institute of New Jersey and The Ohio State University Comprehensive Cancer Center.

Study participants will receive pelareorep intravenously on days 1, 2, 15, and 16 of 28-day treatment cycles. Retifanlimab will be administered on day 3 of each cycle, with treatment cycles continuing until disease progression is observed. The co-primary endpoints of the study are safety and objective response rate. Secondary endpoints include progression-free survival, overall survival, and duration of response. Exploratory endpoints include peripheral T cell clonality and pre- vs. post-treatment change in tumor PD-L1 expression.

For more information on the IRENE study, refer to View Source

On December 10, 2021 The Janssen Pharmaceutical Companies of Johnson & Johnson reported Conditional Marketing Authorisation (CMA) of RYBREVANT ▼ (amivantamab) for the treatment of adult patients with advanced NSCLC with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations, after failure of platinum-based therapy (Press release, Johnson & Johnson, DEC 10, 2021, View Source; [SID1234596782]).1 Amivantamab is the first approved treatment in the European Union specifically targeting EGFR exon 20 insertion mutations for NSCLC.1,2,4

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"Patients with NSCLC harbouring EGFR exon 20 insertion mutations represent a specific population who have been underserved by current treatment options that are limited in both number and efficacy.5 The decision made by the European Commission represents an important milestone and recognises that amivantamab offers a new treatment specifically targeted for patients with this alteration," said Antonio Passaro, M.D., Ph.D, Medical Oncologist at the Division of Thoracic Oncology of the European Institute of Oncology in Milan, Italy.†

The CMA is based on results from the Phase 1 CHRYSALIS study, a multicentre, open-label, clinical study evaluating amivantamab as a monotherapy in patients after previous treatment with platinum-based therapy, which demonstrated efficacy and a generally well-tolerated safety profile.‡4,6 The investigator-assessed overall response rate was 37 percent (95 percent CI, 28% – 46%), with a median duration of response of 12.5 months (95 percent CI, 6.5 – 16.1) and 64 percent of patients having a duration of response greater than or equal to 6 months.4 These results were consistent with those reported by blinded independent central review assessment, which showed an overall response rate of 43 percent (34% – 53%), with a median duration of response of 10.8 months (95 percent CI, 6.9 – 15.0) and 55 percent of patients having a duration of response greater than or equal to 6 months.4

Analysis showed the median progression-free survival (time experienced without progression or death) was 8.3 months (95 percent CI, 6.5 – 10.9) and the median overall survival in patients treated with amivantamab was 22.8 months (95 percent CI, 14.6 – not reached).6

The most common adverse events (AEs) at all grades included rash (76 percent), infusion-related reactions (67 percent) and nail toxicity (47 percent), and these were predominantly Grade 1-2.4 Treatment-related discontinuations due to adverse events were seen in three percent of patients.4 Ninety-nine percent of infusion-related reactions occurred with the first infusions and rarely impacted the ability to continue with subsequent treatments (1.1 percent led to treatment discontinuation).4

"This marketing authorisation addresses a high unmet need by bringing a new treatment option to this patient population and their healthcare professionals for the first time in Europe. It is an important step towards our goal to deliver innovative therapies that will transform the trajectory of lung cancer," commented Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC.

Conditional marketing authorisation is the approval of a medicine that addresses unmet medical needs of patients based on less comprehensive data than normally required, where the benefit of immediate availability of the medicine outweighs the risk, and the applicant is able to provide comprehensive clinical data in the future.7 This CMA follows other recent approvals for amivantamab, including the U.S. Food and Drug Administration (FDA), who approved the treatment in May 2021 for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy.8 Additional regulatory applications have been submitted and are being reviewed by other regulatory bodies worldwide.

"We are committed to changing the face of cancer care," said Mathai Mammen, M.D., Ph.D., Global Head, Janssen Research & Development, Johnson & Johnson. "At Janssen, we’re striving to transform long-term patient outcomes and improve quality of life with the right treatment, for the right patient, at the right time."

† Dr Passaro has previously provided paid consultancy services for Janssen in relation to research and advisory boards. He has not been compensated for any media work.

‡ Results reported in the SmPC are from 114 patients with a median follow up of 12.5 months.4 Results reported in Park et al are from 81 patients and a median follow up of 9.7 months.6 Not all efficacy endpoints were reported in the SmPC.4,6

About Amivantamab
Amivantamab is a fully-human EGFR-MET bispecific antibody with immune cell-directing activity that targets tumours with activating and resistance EGFR mutations and MET mutations and amplifications, approved for patients with advanced non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations after failure of platinum-based therapy.1,9,10,11,12 Amivantamab is being studied in multiple clinical trials, including:13

the Phase 1/1b, CHRYSALIS-2 (NCT04077463) study assessing the combination of amivantamab and lazertinib in patients who have progressed after treatment with osimertinib and chemotherapy, as well as lazertinib as a monotherapy14
as first-line therapy in the Phase 3 MARIPOSA (NCT04487080) study assessing amivantamab in combination with lazertinib, a novel third-generation EGFR tyrosine kinase inhibitor (TKI), against osimertinib and against lazertinib alone in untreated advanced EGFR-mutated NSCLC15
the Phase 3 MARIPOSA-2 (NCT04988295) study assessing the efficacy of lazertinib, amivantamab and carboplatin-pemetrexed vs. with carboplatin-pemetrexed in participants with locally advanced or metastatic EGFR Exon 19del or Exon 21 L858R substitution NSCLC after osimertinib failure16
the Phase 3 PAPILLON (NCT04538664)study assessing amivantamab in combination with carboplatin-pemetrexed vs carboplatin-pemetrexed for patients with advanced or metastatic EGFR-mutated NSCLC with exon 20 insertion mutations17
the Phase 1 PALOMA (NCT04606381) study assessing the feasibility of subcutaneous (SC) administration of amivantamab based on safety and pharmacokinetics and to determine a dose, dose regimen and formulation for amivantamab SC delivery with the aim to find effective solutions that positively impact patient management.18
About the CHRYSALIS Study
CHRYSALIS (NCT02609776) is an open-label, multicentre, first-in-human Phase 1 study to evaluate the safety, pharmacokinetics and preliminary efficacy of amivantamab as a monotherapy, in combinations with lazertinib and in combination with platinum-based chemotherapy, in patients with advanced NSCLC with various EGFR mutations.3 In the study, investigators assessed efficacy using overall response rate per Response Evaluation Criteria in Solid Tumours Version 1.1* (RECIST v1.1), clinical benefit rate, median duration of response and median progression-free survival, as well as the safety profile of amivantamab.3,19

The study will enrol 780 patients with advanced NSCLC.3 The study consists of two parts: the first consists of amivantamab monotherapy and combination dose escalations, and the second consists of amivantamab monotherapy and combination dose expansions.3

The first cohort of participants received intravenous infusions of amivantamab as monotherapy.3

*RECIST (version 1.1) refers to Response Evaluation Criteria in Solid Tumours, which is a standard way to measure how well solid tumours respond to treatment and is based on whether tumours shrink, stay the same or get bigger.3

About Non-Small Cell Lung Cancer (NSCLC)
In Europe, it is estimated that 477,534 patients were diagnosed with lung cancer in 2020, with around 85 percent diagnosed with NSCLC.20,21 Lung cancer is Europe’s biggest cancer killer, with more deaths than breast cancer and prostate cancer combined.20

The main subtypes of NSCLC are adenocarcinoma, squamous cell carcinoma and large cell carcinoma.21 Among the most common driver mutations in NSCLC are alterations in EGFR, which is a receptor tyrosine kinase supporting cell growth and division.22 EGFR mutations are present in 16 to 19 percent of Caucasian patients with NSCLC and present in 37 to 41 percent of Asian patients who have NSCLC adenocarcinoma.23 The five-year survival rate for all people with metastatic NSCLC and EGFR mutations who are treated with EGFR TKIs is less than 20 percent.24 Patients with EGFR exon 20 insertion mutations have a real-world five-year overall survival (OS) of 8 percent in the frontline setting, which is worse than patients with EGFR exon 19 deletions or L858R mutations, who have a real-world five-year OS of 19 percent.25

On December 10, 2021 Pfizer Inc. (NYSE: PFE) reported that its board of directors declared an increase in the quarterly cash dividend on the company’s common stock to $0.40 for the first-quarter 2022 dividend, payable March 4, 2022, to holders of the Common Stock of record at the close of business on January 28, 2022 (Press release, Pfizer, DEC 10, 2021, View Source [SID1234596762]). The first-quarter 2022 cash dividend will be the 333rd consecutive quarterly dividend paid by Pfizer.

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"The increase in dividend is a direct reflection of our strong financial performance and continued confidence in our current product portfolio and R&D pipeline," said Dr. Albert Bourla, Pfizer Chairman and Chief Executive Officer.

On December 10, 2021 Hologic, Inc. (Nasdaq: HOLX) and its subsidiary, Biotheranostics, Inc., reported new data demonstrating that Breast Cancer Index (BCI) not only predicts preferential recurrence-prevention benefit from extended endocrine therapy (EET), but also predicts the overall benefit/risk and likelihood of improved health outcomes from EET in certain hormone receptor positive (HR+) patients (Press release, Hologic, DEC 10, 2021, View Source [SID1234596792]). New data also confirm two biomarkers used in BCI are interconnected molecular drivers of assessing recurrences in HR+ breast cancer. These findings were presented in Spotlight Sessions at the 2021 San Antonio Breast Cancer Symposium (SABCS), which is being held from December 7-10.

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"Extended endocrine therapy often comes with tolerability challenges and even significant adverse events," said study author Marc Buyse, ScD, Associate Professor of Biostatistics at Hasselt University in Belgium. "We found the data to have considerable implications for patient compliance and joint decision-making with their healthcare providers, as patients have a more comprehensive picture of the net benefit of staying on EET so they can better assess the challenges that can come with treatment."

BCI Significantly Predicts Net Treatment Benefit (NTB) of EET in HR+ Breast Cancer

Research has shown that EET may reduce the long-term risk of recurrence in HR+ breast cancer, but treatment is often accompanied by serious adverse events (AEs), such as bone toxicity, endometrial cancer, embolisms, heart disease and more.1-3 The NTB study, which examined novel patient subset data (N=908 HR+ patients) from the Investigation on the Duration of Extended Adjuvant Letrozole (IDEAL) study, sought to determine the ability of BCI to predict the net benefit from 2.5 years vs. 5 years of EET. These data suggest patients should consider EET if they have a High HOXB13/IL17BR (H/I) result, and it confirms there is a significant NTB from EET for patients even when balanced against more serious AEs (i.e., Grade 3 or higher).

BCI Biomarkers Independently Contribute to its Ability to Predict EET Benefit

While clinical and pathologic factors are prognostic, they do not reliably predict benefit from EET like BCI [H/I] does.1-4 The Molecular Grade Index (MGI) study assessed the relationship of proliferation (MGI) and endocrine response (H/I) to further support how the BCI assay works. These data confirmed that the two biomarkers contributing to BCI’s risk assessment (H/I and MGI) drove tumor biology, thus validating BCI’s role in offering personalized extended endocrine decisions based on the individual patient’s tumor.

"These data analyzing H/I and MGI genes solidify our understanding of the relationship between these two critical components of BCI," said study author Reshma Mahtani, DO, Professor of Medicine at the University of Miami, Sylvester Comprehensive Cancer Center. "The insights confirm H/I and MGI are interdependent contributors of risk and benefit thus both necessary elements working in combination to determine risk of recurrences in HR+ breast cancer, further ensuring providers are equipped to make informed prognoses in routine care with BCI."

About Breast Cancer Index

Breast Cancer Index is a gene expression-based test uniquely positioned to provide information to help physicians individualize treatment decisions for patients with early-stage, HR+ breast cancer. This breakthrough test helps oncologists and patients navigate the difficult trade-offs between taking steps to prevent recurrence of their disease and facing significant side effects and safety challenges related to unnecessary treatment. Breast Cancer Index has guideline designation from the American Joint Committee on Cancer for cancer staging based on molecular profile. ASCO (Free ASCO Whitepaper), NCCN, the European Group on Tumor Markers (EGTM) and St. Gallen acknowledge Breast Cancer Index as a biomarker to inform the chemotherapy decision; and NCCN and EGTM acknowledge Breast Cancer Index as a biomarker to inform the extended endocrine treatment decision. It is the only validated, commercially available test that predicts benefit from extended endocrine therapy. Breast Cancer Index is intended for routine clinical use, and treatment decisions based on results are the responsibility of the physician. It is a laboratory developed test (LDT) performed in a CLIA-certified and CAP-accredited diagnostic laboratory and is not required to be cleared or approved by the US Food and Drug Administration. For more information, visit www.breastcancerindex.com.

On December 10, 2021 Targovax ASA’s (the "Company") stock exchange reported that published on 30 November 2021 regarding the commencement of the subscription period in the rights issue of 101,744,186 new shares in the Company (the "Offer Shares") at a subscription price of NOK 1.72 per offer share (the "Rights Issue"), (Press release, Targovax, DEC 10, 2021, View Source [SID1234596744])

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The period for trading in subscription rights (ticker code "TRVXT") in the Rights Issue expires today, on 10 December 2021, at 16:30 hours (CET). Over-subscription and subscription without subscription rights are permitted.

The subscription period for the Rights Issue will expire at 16:30 hours (CET) on 14 December 2021.

Subscription rights that are not used to subscribe for Offer Shares before the expiry of the subscription period (14 December 2021 at 16:30 hours (CET)) or sold before 16:30 hours (CET) today, on 10 December 2021, will have no value and will lapse without compensation to the holder.