On December 10, 2021 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported new follow-up efficacy, safety and patient-reported outcomes (PROs) data from the phase II CITYSCAPE trial, investigating the novel anti-TIGIT cancer immunotherapy tiragolumab plus Tecentriq (atezolizumab) compared with Tecentriq alone as an initial (first-line) treatment for people with PD-L1-positive metastatic non-small cell lung cancer (NSCLC) (Press release, Hoffmann-La Roche, DEC 10, 2021, View Source [SID1234596738]). The full results are being featured as an oral presentation in the Proffered Paper session 2 (Abstract LBA2) at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Immuno-Oncology Congress 2021, taking place 8-11 December.1

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"These encouraging results suggest that combining anti-TIGIT and anti-PD-L1 cancer immunotherapies such as tiragolumab and Tecentriq could potentially represent a novel approach to address unmet needs in cancer," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "With tiragolumab, we have the largest and most advanced anti-TIGIT clinical programme, and we look forward to the results of our phase III trials in lung cancer and other challenging tumour types."

After 2.5 years median follow-up, tiragolumab plus Tecentriq continued to show an improvement in the intention-to-treat (ITT) population (n=67), driven by the PD-L1-high population (TPS ≥ 50%) (n=29). In the ITT population, the combination reduced the risk of disease worsening or death (progression-free survival; PFS) by 38% (median PFS=5.6 vs. 3.9 months; hazard ratio (HR)=0.62, 95% CI: 0.42-0.91) and improved overall response rates (ORR) (38.8% vs. 20.6%) compared with Tecentriq alone. A predefined exploratory analysis in the PD-L1-high population showed a 71% reduction in the risk of disease worsening or death (median PFS=16.6 vs. 4.1 months; HR=0.29, 95% CI: 0.15-0.53) and a clinically meaningful improvement in ORR (69% vs. 24.1%) with the combination compared with Tecentriq alone.1

The analysis also showed that tiragolumab plus Tecentriq improved overall survival (OS), a secondary endpoint of the study, in the ITT population, which was driven by the PD-L1-high population. After 2.5 years median follow-up, median OS was 23.2 vs. 14.5 months (HR=0.69, 95% CI: 0.44-1.07) in the ITT population. The exploratory data in the PD-L1-high population showed a clinically meaningful OS improvement. The median was not reached for the tiragolumab regimen and is projected to be greater than 30.3 months based on the lower confidence interval (NE (30.3-NE) vs. 12.8 months (4.7-24.2); HR=0.23, 95% CI: 0.10-0.53).1

Data suggest that the combination was generally well-tolerated, showing similar rates of Grade 3-4 treatment-related adverse events (AEs) when adding tiragolumab to Tecentriq compared with Tecentriq alone (22.4% vs. 25%). The most common all cause AEs (rate greater than 5% difference between study groups) seen with the combination were infusion-related reactions, stiffness, dry skin, fatigue and rash. After longer follow-up, no new safety signals were observed with the combination. Patients generally reported minimal-to-moderate symptoms and generally maintained their quality of life compared with the start of treatment. PRO data from this exploratory analysis showed that lung symptoms, such as dyspnoea and pain, did not appear to deteriorate with the addition of tiragolumab to Tecentriq.1

CITYSCAPE study forms the basis of an industry-leading development programme across multiple settings and tumour types.3

The phase III SKYSCRAPER-01 trial is currently ongoing to confirm these results in the PD-L1-high population, with the goal of bringing this treatment option to patients. Earlier this year, tiragolumab was granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration – representing the first anti-TIGIT therapy to be granted this designation and the 37th BTD for Roche’s portfolio of medicines. Since 2020, Roche has initiated five phase III trials evaluating tiragolumab plus Tecentriq in early and metastatic disease in lung (SKYSCRAPER-01, SKYSCRAPER-02, SKYSCRAPER-03) and oesophageal cancers (SKYSCRAPER-07, SKYSCRAPER-08). Tiragolumab is also being evaluated in other solid tumours as well as in haematological cancers.

About the CITYSCAPE study1
CITYSCAPE is a global phase II, randomised and blinded study evaluating tiragolumab plus Tecentriq (atezolizumab) compared with Tecentriq alone in 135 patients with first-line PD-L1-positive locally advanced, unresectable or metastatic non-small cell lung cancer. Patients were randomised 1:1 to receive either tiragolumab plus Tecentriq or placebo plus Tecentriq, until progressive disease or loss of clinical benefit. Co-primary endpoints are overall response rate (ORR) and progression-free survival (PFS). Secondary endpoints include safety, overall survival (OS) and patient-reported outcomes (PROs). PRO results were assessed with EORTC QLQ-C30, a questionnaire developed to assess the quality of life of people with cancer, administered at baseline and throughout study treatment.

About tiragolumab
Tiragolumab is a first-in-class novel immune checkpoint inhibitor with an intact Fc region. Tiragolumab selectively binds to TIGIT, a novel inhibitory immune checkpoint which suppresses the immune response to cancer.1 Based on preclinical research, tiragolumab is thought to work as an immune amplifier with other cancer immunotherapies such as Tecentriq.2 The TIGIT pathway is distinct but complementary to the PD-L1/PD-1 pathway. Dual blockade with tiragolumab and Tecentriq may help overcome immune suppression and restore the immune response.1

About Tecentriq (atezolizumab)
Tecentriq is a monoclonal antibody designed to bind with a protein called Programmed Death Ligand-1 (PD-L1), which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. The development of Tecentriq and its clinical programme is based on our greater understanding of how the immune system interacts with tumours and how harnessing a person’s immune system combats cancer more effectively.

Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of NSCLC, SCLC, certain types of metastatic urothelial cancer, in PD-L1-positive metastatic triple-negative breast cancer and for hepatocellular carcinoma. In the US, Tecentriq is also approved in combination with Cotellic (cobimetinib) and Zelboraf (vemurafenib) for the treatment of people with BRAF V600 mutation-positive advanced melanoma.

About Roche in cancer immunotherapy
Roche’s rigorous pursuit of groundbreaking science has contributed to major therapeutic and diagnostic advances in oncology over the last 50 years, and today, realising the full potential of cancer immunotherapy is a major area of focus. With over 20 molecules in development, Roche is investigating the potential benefits of immunotherapy alone, and in combination with chemotherapy, targeted therapies or other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system to attack their cancer. Our scientific expertise, coupled with innovative pipeline and extensive partnerships, gives us the confidence to continue pursuing the vision of finding a cure for cancer by ensuring the right treatment for the right patient at the right time.

In addition to Roche’s approved PD-L1 checkpoint inhibitor, Tecentriq (atezolizumab), Roche’s broad cancer immunotherapy pipeline includes other checkpoint inhibitors, such as tiragolumab, a novel cancer immunotherapy designed to bind to TIGIT, individualised neoantigen therapies and T-cell bispecific antibodies.

On December 10, 2021 Inceptua Group – pharmaceutical company and service partner – reported that the European Commission (EC) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved the transfer of the marketing authorization for Apealea (paclitaxel micellar) from Oasmia Pharmaceutical AB to Inceptua AB (Press release, Inceptua Medicines, DEC 10, 2021, View Source;utm_medium=rss&utm_campaign=inceptua-receives-approval-of-marketing-authorization-transfer-of-apealea-paclitaxel-micellar-for-the-treatment-of-ovarian-cancer [SID1234596756]). Apealea is approved in combination with carboplatin for the treatment of adult patients with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer.

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Inceptua have the exclusive right to distribute and commercialize Apealea in the EU, Norway, Iceland, Liechtenstein, Switzerland and the UK.

Stefan Fraenkel, Chief Executive Officer, Inceptua Group, says:

"We are pleased that the European Commission and MHRA has granted approval for Inceptua to market Apealea, Europe’s first non-Cremophor EL formulation of paclitaxel. With our deep commercialization capabilities and expertise, Inceptua is uniquely positioned to maximize the availability of Apealea for patients with ovarian cancer in this region."

Clive Whitcher, Head of Inceptua Pharma, says:

"With Apealea, ovarian cancer patients now have a treatment option that provides a shorter infusion time without mandatory premedication. We believe there is great potential for Apealea to help patients with ovarian cancer and we look forward to bringing this important treatment to patients in need throughout Europe."

On 25 March 2020, Oasmia Pharmaceutical AB and US based Elevar Therapeutics Inc. signed a global strategic partnership deal to commercialise Apealea. On 28 December 2020, Inceptua signed a licence agreement with Elevar Therapeutics Inc. to commercialise Apealea in Europe.

About Ovarian Cancer

Ovarian cancer is one of the most common female cancers affecting the primary reproductive organs.1 Globally, it is the third most common cancer among women and has the highest mortality rate2,3. Although ovarian cancer has a lower prevalence in comparison with breast cancer, it is three times more lethal, and it is predicted that, by the year 2040, the mortality rate of this cancer will rise significantly4,5. About half of the women who are diagnosed with ovarian cancer are 63 years or older and many of these patients are predisposed to age-related comorbidities, such as diabetes, which can influence treatment response and prognosis6.

About Apealea (paclitaxel micellar)

Apealea is a patented, water-soluble, intravenously injectable, non-Cremophor based formulation of paclitaxel that can be given without premedication such as steroids and with a shorter infusion time. Paclitaxel is a well-known chemotherapy agent used to treat breast, ovarian, lung, bladder, prostate, melanoma, and oesophageal cancer, as well as other types of solid tumour cancers. Cremophor-EL, is a formulation vehicle used for various poorly-water soluble drugs, including the anticancer agent paclitaxel and is associated with allergic reactions. Apealea received marketing authorization by the European Commission in November 2018, making it Europe’s first non-Cremophor-EL formulation of paclitaxel approved for use in ovarian cancer.

On December 10, 2021 The Multiple Myeloma Research Foundation (MMRF) reported that new insights related to novel targets, risk assessment, and precision medicine approaches generated through the use of the MMRF landmark CoMMpass Study will be presented at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (Press release, Multiple Myeloma Research Foundation, DEC 10, 2021, View Source [SID1234596777]). In total, ASH (Free ASH Whitepaper) will feature 33 presentations developed through the work of more than 200 researchers from 180 institutions all using the CoMMpass data.

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The MMRF initiated the CoMMpass Study more than ten years ago to address the need for a large, comprehensive, genomic and clinical data set that was publicly available to researchers to realize the potential of precision medicine. It has now become one of the largest longitudinal genomic datasets of any cancer and the source of more than 150 myeloma scientific publications and abstracts. The insights generated by CoMMpass have led to groundbreaking discoveries that have transformed the research community’s understanding of myeloma at a genomic level. The MMRF is now working with five institutions (Beth Israel Deaconess Medical Center, Emory University, Mt. Sinai School of Medicine, Mayo Clinic, and Washington University, St. Louis) on a companion project called Immune Atlas that will complement the genomic and clinical data in CoMMpass with high dimensional immune profiling of the same patients, creating standards and generating robust immune data to further advance precision medicine. The initial findings from this effort are among the 33 abstracts.

"CoMMpass has exceeded our expectations as a wellspring for insightful research and to generate new hypotheses that we can test in the laboratory and at the bedside," said Hearn Jay Cho, MD, PhD, Chief Medical Officer, the MMRF. "CoMMpass continues to shape our research agenda, particularly in precision medicine clinical trials such as MyDRUG and MyCheckpoint, and this will only expand with the addition of Immune Atlas. We are also looking beyond CoMMpass by building our next major data set with the MMRF CureCloud."

The MMRF CureCloud was launched in 2019 as a next generation data source capturing genomic sequencing data through blood samples of newly diagnosed myeloma patients and longitudinal clinical data shared by patients through their electronic medical records. The first abstracts derived from CureCloud are being presented at ASH (Free ASH Whitepaper) representing the next game-changing longitudinal study in myeloma research. Unique to CureCloud is that it was specifically designed to not only power research, but also as an immediate and ongoing resource to clinicians and patients. Each CureCloud patient receives their personal genomic data report, learns about possible clinical trials, and will have ongoing access to new and evolving insights related to their disease. The database is designed to continuously identify insights from patients that will help other patients gain deeper understanding of possible treatment paths as more patients join the program.

"Our mission is to deliver a cure for each and every myeloma patient. We know that getting there will require access to data to progress the development of precision medicines. This is our ultimate focus as we share data with our research collaborators and patients every day," said Michael Andreini, President and CEO, the MMRF. "The data and insights we share are generating a deeper understanding of the biology of myeloma and helping to identify new targets and markers for risk and disease progression. They are also driving the discovery and delivery of more precise treatments for all patients as we pursue a world without myeloma."

For complete data on MMRF abstracts being presented at the 63rd ASH (Free ASH Whitepaper) Annual Meeting please contact C.J. Volpe at [email protected]

About the MMRF CoMMpass StudySM
The MMRF CoMMpass Study is a longitudinal study of patients with newly diagnosed active multiple myeloma. The goal is to map the genomic profile of each patient to clinical outcomes to develop a more complete understanding of patient responses to treatments. A cornerstone of the MMRF’s Personalized Medicine Initiative, the study is collecting and analyzing tissue samples, clinical data and genetic information from 1,000 newly diagnosed multiple myeloma patients for at least eight years. The CoMMpass Study was made possible by a $40M investment by the MMRF.
The MMRF CoMMpass Study opened in July of 2011 and now includes 1,150 patients from 76 sites in the United States, Canada and European Union. Data from the MMRF CoMMpass Study is made available to researchers via the MMRF’s Researcher Gateway (View Source), an online, open-access portal designed to make key genomic and clinical data available for additional study. The MMRF CoMMpass Study is being supported through a public-private partnership of patient donors and industry partners, including Takeda Oncology, Amgen, Bristol-Myers Squibb, Janssen Pharmaceuticals, Inc. and Janssen Diagnostics. Additional collaborating research partners include the Translational Genomics Research Institute, Van Andel Research Institute and GNS Healthcare. Please visit www.themmrf.org/research-partners/the-commpass-study to learn more about the study.

On December 10, 2021 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) a clinical-stage biotechnology company developing eganelisib, a first-in-class, oral, immuno-oncology macrophage reprogramming therapeutic, reported updated data from the ongoing MARIO-3 clinical study during the 2021 San Antonio Breast Cancer Symposium (SABCS). MARIO-3 is the Company’s ongoing Phase 2 study evaluating eganelisib in combination with atezolizumab (Tecentriq) and nab-paclitaxel (Abraxane) in frontline metastatic triple negative breast cancer (TNBC) (Press release, Infinity Pharmaceuticals, DEC 10, 2021, View Source [SID1234596757]).

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"These promising updated data suggest that the addition of eganelisib to atezolizumab and nab-paclitaxel has the potential to provide improved patient outcomes over benchmark IMpassion130 data in front-line metastatic TNBC," said Hatem Soliman, M.D., MARIO-3 Investigator and Medical Director, Clinical Trials Office at the Moffitt Cancer Center. "Tumor reductions in 88.6% of evaluable patients were associated with a disease control rate of 81.4% in patients with PD-L1 negative tumors who are among the most challenging to treat. Importantly, we see that this impressive disease control rate is translating into durable clinical benefit, regardless of PD-L1 status, with encouraging mPFS compared to the IMpassion130 benchmark study. These compelling findings, combined with eganelisib’s safety and tolerability profile, indicate that eganelisib has the potential to become an important new treatment option for advanced TNBC patients."

Adelene Perkins, Chief Executive Officer and Chair, Infinity Pharmaceuticals, said, "With a median duration of follow-up of almost 10 months, the durable clinical benefit seen with the eganelisib combination reinforces our vision of bringing better therapies to frontline TNBC patients. When compared to the IMpassion130 benchmark data, a 47% improvement in median PFS for patients with PD-L1 positive tumors and a 30% improvement in median PFS for patients with PD-L1 negative tumors provides consistent and compelling evidence of eganelisib’s potential to improve outcomes for these patients."

MARIO-3 Key Data Updates:

This data update includes 50 patients enrolled and 44 evaluable as of the October 2, 2021 data cutoff date, with a median duration of follow up of 9.9 months.
Of evaluable patients, tumor reduction was observed in 92.8% of patients with PD-L1 positive tumors (13/14) and 85.2% of patients with PD-L1 negative tumors (22/27).
Disease control rate (DCR)
92.8% (13/14) DCR in patients with PD-L1 positive tumors: CR 14.3% (2/14), PR 57.1% (8/14), SD 21.4% (3/14)
81.4% (22/27) DCR in patients with PD-L1 negative tumors: complete response (CR) 0% (0/27), partial response (PR) 48.1% (13/27), stable disease (SD) 33.3% (9/27)
Progression free survival (PFS)
In patients with PD-L1(+) tumors, median PFS in MARIO-3 was 11.0 months, a 47% improvement in mPFS compared to the 7.5 months reported for atezolizumab and nab-paclitaxel alone in IMpassion130
In patients with PD-L1(-) tumors, median PFS in MARIO-3 was 7.3 months, a 30% improvement compared to the 5.6 months reported for atezolizumab and nab-paclitaxel alone in IMpassion130
72% of the 32 PD-L1 (+) and PD-L1(-) patients treated since the June 26, 2021 data cut remain on treatment
67% of the PD-L1(-) patients who reached the median PFS of 7.3 months remain on treatment
Safety
MARIO-3 did not demonstrate any new safety signals compared to benchmark trials, and its safety profile was consistent with expectations for the three component drugs. The most common Grade 3 or higher treatment-related TEAEs were hepatic AEs (18%); neutropenia AEs (16%); skin AEs (12%); fatigue, diarrhea and peripheral sensory neuropathy (6% each); and vomiting and weight decreased (2% each). Seven patients (14%) discontinued treatment for treatment-related TEAEs and nine patients (18%) had treatment-related SAEs.
Quantification across 11 paired tumor biopsies shows increased immune activation and decreased immune suppression including an increase in CD8+ T cells, activated T cells, and anti-tumor M1 macrophages and a decrease in tumor cells and pro-tumor M2 macrophages resulting in an increase in the M1:M2 ratio.
Paired tumor biopsy data show 5 of 8 patients with PD-L1(-) tumors converting to PD-L1(+) two months after treatment utilizing the same 1% PD-L1 cutoff standard used in the benchmark IMpassion130 study. PD-L1 expression also increased in the three patients with PD-L1(+) tumors who started the study above the 1% cutoff. None of the patients converting to PD-L1(+) or patients with PD-L1(+) tumors who experienced increased PD-L1 expression had disease progression.
KOL Event Information

Infinity will host a KOL event today, December 10, 2021, at 9:30AM ET with Hatem Soliman, M.D., MARIO-3 Investigator and Medical Director, Clinical Trials Office at the Moffitt Cancer Center, to review the MARIO-3 data presented at SABCS.

To register for the webinar, please click here.

On December 10, 2021 Johnson & Johnson (NYSE: JNJ) reported thatit will host a conference call for investors at 8:30 a.m. (Eastern Time) on Tuesday, January 25th to review fourth-quarter results. Joaquin Duato, incoming Chief Executive Officer, Joseph J. Wolk, Executive Vice President and Chief Financial Officer and Jessica Moore, Vice President, Investor Relations will host the call (Press release, Johnson & Johnson, DEC 10, 2021, View Source;johnson-to-host-investor-conference-call-on-fourth-quarter-results-301442424.html [SID1234596778]).

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Investors and other interested parties can access the webcast/conference call in the following ways:

The webcast and presentation material are accessible at Johnson & Johnson’s website www.investor.jnj.com. A replay of the webcast will be available approximately three hours after the conference call concludes.
By telephone: for both "listen-only" participants and those financial analysts who wish to take part in the question-and-answer portion of the call, the telephone dial-in number in the U.S. is 877-869-3847. For participants outside the U.S., the dial-in number is 201-689-8261.
A replay of the conference call will be available until approximately 12:00 a.m. on February 8th. The replay dial-in number for U.S. participants is 877-660-6853. For participants outside the U.S., the replay dial-in number is 201-612-7415. The replay conference ID number for all callers is 13725514.
The press release will be available at approximately 6:45 a.m. (Eastern Time) the morning of the conference call.
Please refer to www.investor.jnj.com for a complete list of currently planned earnings webcast/conference calls. Please note the first-quarter date of Tuesday, April 19th, 2022.