On December 10, 2021 Oasmia Pharmaceutical AB (Oasmia), an oncology-focused specialty pharmaceutical company, reprted that the transfer of its marketing authorization for Apealea (paclitaxel micellar) to Inceptua AB has received approval from the European Commission and the UK Medicines and Healthcare products Regulatory Agency (MHRA) (Press release, Oasmia, DEC 10, 2021, View Source [SID1234596759]).

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As the new marketing authorization holder, Inceptua will assume full regulatory responsibility for Apealea in the EU, Norway, Iceland, Liechtenstein and the UK.

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.

Francois Martelet, Chief Executive Officer, Oasmia, commented: "This marketing authorization transfer is in line with Oasmia’s strategy, to commercially launch Apealea through partners and build a diversified pipeline focused on hard-to-treat and late-stage cancers using different mechanisms of action. We anticipate receiving our first royalties on Apealea sales during 2022 following commercial product launches in several key European markets."

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 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 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the phase II coopERA Breast Cancer study met its primary endpoint in the neoadjuvant treatment of early stage ER-positive, HER2-negative breast cancer (Press release, Hoffmann-La Roche, DEC 10, 2021, View Source [SID1234596754]). Breast cancer is the most frequently diagnosed type of cancer, with major societal impact.2 Hormone receptor (HR)-positive breast cancer is the most common subtype, representing ~70% of all diagnoses, or an estimated 1.6 million cases annually across the world.2,3

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"The coopERA Breast Cancer results show the potential positive impact giredestrant could bring for people with early, oestrogen receptor-positive breast cancer, and provide a strong rationale for our ongoing phase III lidERA Breast Cancer study in the adjuvant setting," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "At Roche, we are striving to develop new treatments that might improve or extend the lives of many people with ER-positive breast cancer."

The coopERA Breast Cancer trial is evaluating the efficacy and safety of neoadjuvant treatment with giredestrant (formerly known as GDC-9545), an investigational next generation selective oestrogen receptor degrader (SERD) versus standard of care treatment (anastrozole) in postmenopausal women with oestrogen receptor (ER)-positive, HER2-negative, untreated early breast cancer. The primary endpoint of the study, which measured suppression of the tumour proliferation marker Ki67 was met, following two weeks of treatment with giredestrant versus anastrozole:1

Giredestrant showed a statistically significant mean Ki67 reduction of 75% (95% CI: –80%, –70%) versus 67% for anastrozole (95% CI: –73%, –59%; p=0.0433).
The secondary endpoint of complete cell cycle arrest rate was 19.6% with giredestrant versus 12.8% with anastrozole (95% CI: -4.25, 17.97), which suggests that giredestrant was better at stopping tumour cell proliferation than anastrozole.
Giredestrant was found to be well tolerated and have a safety profile consistent with previous clinical trials.4,5
Final analysis, including overall response rates and combination data with palbociclib are expected next year.
"A significant unmet need remains in early ER-positive breast cancer with currently around half of people having to stop treatment for reasons such as the toll of side effects," said Sara Hurvitz, coopERA Breast Cancer Principal Investigator. "The superior, robust anti-tumour activity of giredestrant after just two weeks of treatment in coopERA Breast Cancer provides early insights into its potential as an effective and tolerable alternative treatment in the early-stage setting."

The coopERA Breast Cancer study is one of several studies to be presented at the San Antonio Breast Cancer Symposium (7-10 December 2021) showing progress in Roche’s comprehensive ER-positive clinical development programme and it provides further evidence of giredestrant’s clinical activity and tolerable safety profile. This includes:

Abstract #1842 – an analysis of the GO39932 study demonstrated encouraging clinical activity of giredestrant as a single agent and in combination with palbociclib, with consistent activity across analysed biomarkers.6
Abstract #1186 – a comprehensive cardiac safety analysis of the GO39932 study found no clinically relevant cardiac effects with 100 mg of giredestrant. A lower, standardised once-daily 30 mg dose has been selected for the giredestrant development programme.7
Abstract #2041 – a ‘trial in progress’ update on the phase III lidERA Breast Cancer study, investigating giredestrant in over 4,000 people with early-stage ER-positive, HER2-negative breast cancer. It is the first study to evaluate an oral SERD in the adjuvant setting.8

About giredestrant
Giredestrant is a potent, next generation investigational selective oestrogen receptor (SERD) with best-in-class potential. It is designed to fully block oestrogen receptor (ER) signalling with robust receptor occupancy and demonstrates an exceptional preclinical profile. Oestrogen encourages ER-positive breast cancer cells to grow by attaching to the ER. Giredestrant works by blocking this receptor to prevent the action of oestrogen, and in the process causes the receptor to be degraded. This investigational medicine has also shown efficacy regardless of ESR1 mutation status (mutations in the ESR1 gene are important mechanisms of resistance to hormone therapy).9,10,11,12,13

Given orally, giredestrant delivers an encouraging clinical efficacy and safety profile and has shown superior pre-clinical potency over other SERDs in development. The oral administration of giredestrant has the potential to transform the treatment experience for patients, offering greater convenience and a less painful option compared to therapies administered via intramuscular injection.4,5,9

Giredestrant has a comprehensive development programme across a broad range of settings and treatment combinations for patients with ER-positive, HER2-negative breast cancer. Roche have completed recruitment of patients into a phase II study in second/third-line ER-positive, HER2-negative locally advanced or metastatic breast cancer (acelERA Breast Cancer), and are currently enrolling patients into two phase III studies (persevERA Breast Cancer, lidERA Breast Cancer) evaluating giredestrant across early and metastatic ER-positive, HER2-negative breast cancer settings, as a monotherapy or in combination with palbociclib. In the phase I/II MORPHEUS study giredestrant is being investigated in combination with multiple treatment partners in pre-treated metastatic ER-positive, HER2-negative breast cancer. We are also planning to investigate giredestrant in ER-positive, HER2-positive breast cancer. A standardised once-daily 30 mg dose has been selected for the giredestrant development programme.14,15,16,17

Giredestrant received U.S. Food and Drug Administration Fast Track Designation (FTD) as a second and third-line treatment for ER-positive, HER2-negative, metastatic breast cancer. FTD is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.18

About coopERA Breast Cancer (NCT04436744)19
An open-label, two-arm, phase II study to evaluate the efficacy, safety, and pharmacokinetics of giredestrant versus anastrozole (in the window of opportunity phase) and giredestrant plus palbociclib compared with anastrozole plus palbociclib (in the neoadjuvant phase) in postmenopausal women with untreated, ER-positive, HER2-negative early breast cancer. The primary endpoint of the study is the geometric change in Ki67 scores (a measure of how quickly cancer cells are proliferating) from baseline to week 2 during the window of opportunity phase. Secondary endpoints include complete cell cycle arrest rate, safety outcomes and plasma concentration of giredestrant.

About lidERA Breast Cancer20
An open-label, two-arm, randomised, multicentre, phase III study to evaluate efficacy and safety of adjuvant giredestrant compared with endocrine therapy of physician’s choice in people with medium- and high-risk stage I-III ER-positive, HER2-negative early breast cancer. The primary endpoint of the study is invasive disease-free survival (iDFS), measured from randomisation to the first occurrence of an iDFS event (up to 10 years). Secondary endpoints include overall survival and disease-free survival. LidERA Breast Cancer is currently the only ongoing early breast cancer trial investigating an oral SERD.

About Roche in breast cancer
Roche has been advancing breast cancer research for more than 30 years with the goal of helping as many people with the disease as possible. Our medicines, along with companion diagnostic tests, have contributed to bringing breakthrough innovations in HER2-positive and triple-negative breast cancers. As our understanding of breast cancer biology rapidly improves, we are working to identify new biomarkers and approaches to treatment for all forms of early and advanced breast cancer, including triple-negative and hormone receptor-positive.

Our targeted medicines Herceptin (trastuzumab), Perjeta (pertuzumab), Phesgo, Kadcyla (trastuzumab emtansine) and Tecentriq (atezolizumab) are continuing to transform the treatment of early and advanced HER2-positive and triple-negative breast cancers and, through our clinical programmes, we hope to bring new treatment combinations to people with breast cancer, ultimately improving outcomes.

On December 10, 2021 Eli Lilly and Company (NYSE: LLY) and Regor Therapeutics Group reported that they have entered into a multi-year research collaboration and licensing agreement to discover, develop and commercialize novel therapies for metabolic disorders (Press release, Eli Lilly, DEC 10, 2021, View Source [SID1234596753]).

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Under the terms of the agreement, Lilly will have a license to select Regor intellectual property with an option to extend the license. Lilly will be responsible for clinical development, manufacturing and commercialization worldwide, except for People’s Republic of China, Macau, Hong Kong and Taiwan, where Regor will maintain these rights and responsibilities. The agreement will allow each company the opportunity to fully leverage both parties’ existing compounds and technologies globally to maximize patient treatment choice.

"Through this collaboration, we will have the opportunity to expand treatment options available to patients suffering from metabolic disorders," said Ruth Gimeno, Ph.D., vice president, diabetes research and clinical investigation at Lilly. "Regor’s technology will also allow Lilly to further accelerate innovation and deliver breakthrough therapies in obesity and diabetes."

"In a little over three years, Regor has established a world-class research organization exemplified by our Computer Accelerated Rational Discovery platform. This collaboration is a recognition for Regor’s core technology and research capabilities, but more importantly, it is an extraordinary opportunity to discover, develop and commercialize novel therapeutics to help the millions of patients in the world, "said Xiayang Qiu, Ph.D., founder CEO of Regor. "We are pleased to establish this strategic collaboration with Lilly, a top global leader in metabolic disorders such as diabetes and obesity."

Regor will receive an upfront payment of up to $50 million, which partially includes an equity investment by Lilly in Regor, subject to the parties entering into standard equity agreements. The company is also eligible to receive up to $1.5 billion in potential payments based on the achievement of prespecified preclinical, clinical development and commercial milestones, as well as tiered royalties from low-single to low-double digits on sales resulting from the agreement.

This transaction will be reflected in Lilly’s reported results and financial guidance according to Generally Accepted Accounting Principles (GAAP). There will be no change to Lilly’s 2021 non-GAAP earnings per share guidance as a result of this transaction.