On March 31, 2022 Aravive, Inc. (Nasdaq: ARAV, "the Company"), a late clinical-stage oncology company developing targeted therapeutics to treat metastatic disease, reported fourth quarter and full year ended December 31, 2021 financial results and provided corporate updates (Press release, Aravive, MAR 31, 2022, View Source [SID1234611284]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"In 2021, Aravive made significant progress in advancing the clinical development of batiraxcept for the potential treatment of ovarian, kidney and pancreatic cancer," said Gail McIntyre, Ph.D., DABT, Chief Executive Officer of Aravive. "We initiated the registrational Phase 3 trial of batiraxcept in ovarian cancer and recently reported positive safety and efficacy data from the ongoing Phase 1b trials of batiraxcept in clear cell renal cell carcinoma and pancreatic cancer. We are encouraged by batiraxcept’s early profile in patients across each of these life-threatening cancers with unmet medical needs and are laser-focused on building value for patients and shareholders."

Recent Corporate Highlights

Batiraxcept in Platinum Resistant Ovarian Cancer (PROC): Aravive dosed the first patient in the registration directed Phase 3 trial in April 2021 and is on track to complete enrollment in 2H’22. Topline data from the trial is anticipated to be available in 2Q’23 and the Company expects to be ready to potentially file a BLA during 4Q’23. The global, randomized, double-blind, placebo-controlled Phase 3 trial is evaluating efficacy and tolerability of batiraxcept at a dose of 15 mg/kg in combination with paclitaxel versus placebo in combination with paclitaxel. The trial aims to enroll 350 platinum resistant, high-grade serous ovarian cancer patients who have received 1-4 prior lines of therapy.

Batiraxcept in Clear Cell Renal Cell Carcinoma (ccRCC) and Serum-Based Biomarker: Aravive dosed the first patient in the Phase 1b portion of the Phase 1b/2 trial of batiraxcept in patients with ccRCC in March 2021 and completed enrollment and reported positive preliminary data in November 2021. In March 2022, the Company announced positive updated data and new biomarker data from the Phase 1b portion of the trial in patients with ccRCC. Aravive had previously reported an observable correlation of baseline levels of serum soluble AXL (sAXL)/GAS6 to clinical activity in its Phase 1b PROC trial. As such, one of the objectives of the ongoing Phase 1b/2 ccRCC trial is to evaluate the correlation of baseline sAXL/GAS6 with radiographic response in patients with ccRCC treated with batiraxcept plus cabozantinib. The company anticipates to continue to provide updated biomarker data throughout 2022.

As of February 4, 2022, 26 patients with ccRCC were treated with batiraxcept in the Phase 1b portion of the trial at doses of 15 mg/kg (n=16) and 20 mg/kg (n=10), plus cabozantinib 60 mg daily in previously treated (2L+) patients with ccRCC. There were no dose limiting toxicities observed at either dose and at a median follow up of 4.9 months, 92% of patients remained on study. The best overall response rate (ORR, confirmed + unconfirmed) in the ITT population was 46% and 56% in patients dosed with 15 mg/kg (the recommended Phase 2 dose). The best ORR in the biomarker high population was 63%, and 75% in the biomarker high population dosed at 15 mg/kg. The 6-month progression-free survival (PFS) rate was 79% in the ITT population, 77% in the biomarker high population, and 91% in the 15 mg/kg biomarker high group. The company is on track to report additional updated results from the Phase 1b portion of the trial in the second quarter of 2022.

In January 2022, Aravive dosed the first patient in the Phase 2 portion of the Phase 1b/2 clinical trial of batiraxcept in combination with cabozantinib for the treatment of ccRCC. The company is on track to report preliminary results from the Phase 2 portion of the trial in the second quarter of 2022. The Phase 2 portion of the Phase 1b/2 trial of batiraxcept in ccRCC is an open-label study and aims to enroll 55 patients across three parts.
Batiraxcept in Pancreatic Adenocarcinoma: In August 2021, Aravive dosed the first patient in the Phase 1b portion of its Phase 1b/2 trial of batiraxcept in combination with gemcitabine and nab-paclitaxel as a first-line treatment in patients with advanced or metastatic pancreatic adenocarcinoma who are eligible to receive gemcitabine and nab-paclitaxel combination therapy. Enrollment was completed in January 2022. As of February 4, 2022, 13 patients have been treated with 15 mg/kg batiraxcept in combination with gemcitabine and nab-paclitaxel as a first-line treatment. Analysis of all safety data to date demonstrates that batiraxcept has been generally well-tolerated with no unexpected safety signals. The best ORR was 31% and all patients have had at least eight weeks of follow-up (one radiological image). The company is on track to report additional updated data from the Phase 1b portion of the trial in the second quarter of 2022.

Strengthened Balance Sheet: In January 2022, Aravive raised approximately $10.0 million from the sale of a pre-funded warrant to purchase 4,545,455 shares of the company’s common stock to Eshelman Ventures, LLC at a price of $2.20 per share, which was the consolidated closing bid price of the company’s common stock on The Nasdaq Global Select Market on December 31, 2021. Additionally, Fred Eshelman, Pharm.D., was appointed the Executive Chairman of Aravive, having served as the Non-Executive Chairman of the board since April 2020. In March 2022, the Company raised an additional approximately $10.0 million from the sale of common stock and a pre-funded warrant for an aggregate of a combination of 4,850,241 shares of the company’s common stock and pre-funded warrants to a single healthcare-focused institutional investor and Eshelman Ventures, LLC and issued warrants to purchase an additional aggregate of 4,850,241 shares of common stock in a registered direct offering priced at-the-market under Nasdaq rules. Combined, the additional capital infusions strengthen the Company’s financial position and fund operations as currently planned into 1Q’23.

Expanded Board of Directors: In May 2021, the Company appointed John A. Hohneker, M.D., Sigurd C. Kirk, and Peter T.C. Ho, M.D., Ph.D. to its Board. These independent directors strengthen oversight and broaden the Company’s technical capabilities in clinical and business development.
Fourth Quarter and Full Year 2021 Financial Results
Revenue for the three and twelve months ended December 31, 2021 was $1.0 million and $7.4 million, respectively, compared with $5.7 million for the same periods in 2020. Revenues for 2021 and 2020 were derived solely from the Company’s collaboration and license agreement with 3D Medicines, executed in November 2020 to develop and commercialize batiraxcept in oncology indications in Greater China. Revenues represent a portion of initial signing and milestone payments received from 3D Medicines that is recognized at the time of the receipt and a portion of the payments that is deferred and recognized over the PROC trial period.

Total operating expenses for the three and twelve months ended December 31, 2021 were $14.6 million and $48.1 million, respectively compared with $9.7 million and $36.5 million, respectively, for the same periods in 2020. Non-cash stock-based compensation for the three and twelve months ended December 31, 2021 was $0.6 million and $2.3 million, respectively compared with $0.4 million and $2.0 million, respectively, for the same periods in 2020. In addition, during the twelve months ended December 31, 2020, there were non-recurring non-cash charges for impairment of the Company’s right-of-use asset and leasehold improvements of $5.8 million.

For the three and twelve months ended December 31, 2021, Aravive reported a net loss of $13.0 million and $39.2 million, or $0.62 per share and $1.95 per share, respectively compared to a net loss of $4.0 million and $30.5 million, or $0.25 per share and $1.93 per share, respectively, for the same periods in 2020.

Cash Position
As of December 31, 2021, cash and cash equivalents were $59.4 million, compared to $60.5 million as of December 31, 2020. In January 2022, Aravive announced an approximately $10.0 million investment by Eshelman Ventures and in March 2022, Aravive announced an additional approximately $10 million investment by a healthcare-focused institutional investor and Eshelman Ventures, LLC. The combined approximately $20 million in new capital strengthened the Company’s financial position ahead of multiple anticipated clinical milestones throughout 2022 for each of the Company’s three ongoing clinical programs. The Company anticipates that its current cash and cash equivalents will fund operating plans into 1Q’23.

On Armata 31, 2022 Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a biotechnology company focused on pathogen-specific bacteriophage therapeutics for antibiotic-resistant and difficult-to-treat bacterial infections, reported that, following a vote in favor of the transaction by the Armata shareholders, the Company has completed the closing of the second and final tranche of the Company’s $45 million private placement of its common stock with Innoviva Strategic Opportunities LLC, a wholly-owned subsidiary of Innoviva, Inc. (NASDAQ: INVA) (together, "Innoviva") (Press release, AmpliPhi Biosciences, MAR 31, 2022, View Source [SID1234611283]). In connection with the second closing, Armata issued 5,385,208 common shares and 2,692,604 warrants with an exercise price of $5.00 per share, at a per unit price of $5.00 per unit, in exchange for gross proceeds of approximately $26.9 million. Approximately 99% of the Armata shares represented and voting at the special meeting of shareholders voted in favor of the transaction.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Company and Innoviva closed an initial tranche of the investment on February 9, 2022, which raised gross proceeds of approximately $18.1 million through the issuance of 3,614,792 common shares and warrants to purchase an additional 1,807,396 common shares at a strike price of $5.00 per share.

As of March 31, 2022, and following the second closing, Armata has 36,112,299 shares outstanding and warrants exercisable for 21,147,229 shares of common stock.

Armata was represented in the transaction by Thompson Hine LLP, and Ladenburg Thalmann & Co. Inc. provided a fairness opinion.

Willkie Farr & Gallagher LLP represented Innoviva in the transaction.

In addition, Armata Pharmaceuticals, Inc. filed its Annual Report for the year ended December 31, 2021 on Form 10-K with the SEC on March 17, 2022. The audit opinion included in the Company’s Form 10-K contains a going concern explanatory paragraph. This announcement is made pursuant to the disclosure requirements of NYSE American Company Guide Sections 401(h) and 610(b) and does not represent any change or amendment to the Company’s financial statements or to its Annual report on Form 10-K for the year ended December 31, 2021.

This release does not constitute an offer to sell or the solicitation of an offer to buy any security. The shares offered have not been registered under the Securities Act of 1933, as amended, or applicable state securities laws and may not be offered or sold in the United States or any state thereof absent registration under the securities act and applicable state securities laws or an applicable exemption from registration requirements.

On March 31, 2022 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported results of a retrospective, observational study describing the substantial burden of myelosuppression and its impact on healthcare resource utilization (HCRU) in 3,277 patients being treated with chemotherapy for extensive-stage small-cell lung cancer (ES-SCLC) (Press release, G1 Therapeutics, MAR 31, 2022, View Source [SID1234611282]). The study also described patient outcomes from 21 patients receiving trilaciclib prior to chemotherapy; of these, 17 received commercial trilaciclib in the real-world setting, and four received trilaciclib in clinical trials.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Results showed that the use of trilaciclib prior to chemotherapy was associated with a 50% reduction in the percent of patients with grade ≥ 3 myelosuppressive hematologic adverse events (HAE) in at least one blood cell lineage and a 74% reduction in the percent of all-cause hospitalizations (days 1 to 21 after treatment), compared to patients who received chemotherapy alone. The analyses were derived using structured, real-world, de-identified clinical patient level data from the Integra Connect oncology warehouse. Findings are being presented in a poster session at the Annual Conference of the National Comprehensive Cancer Network (NCCN), held from March 31 to April 2, 2022.

The poster titled, "Burden of Myelosuppression Among Patients with Extensive-Stage Small Cell Lung Cancer Treated with Chemotherapy in a Community Oncology Setting" is available in the scientific publications section of G1’s website.

"The real-world burden of myelosuppressive hematologic adverse events among patients receiving chemotherapy, and the resulting hospitalizations, are routinely underestimated in the community oncology setting," said Jeffrey Scott, M.D., Chief Medical Officer of Integra Connect and lead author of the study. "In this retrospective analysis, nearly 60% of patients receiving chemotherapy alone had a grade ≥ 3 myelosuppressive HAE in at least one lineage, with a sizeable proportion having multilineage (≥ 2 lineages) myelosuppression. Importantly, these data also capture the first real-world experience of using trilaciclib prior to chemotherapy. Among those patients, the use of trilaciclib nearly eliminated not only grade ≥ 3 HAEs associated with multilineage myelosuppression but also all-cause hospitalizations."

In the study, the researchers conducted a primary analysis of 3,277 patients who received chemotherapy alone and a secondary analysis from 21 patients who received trilaciclib prior to chemotherapy, including 17 who received commercial trilaciclib in the real-world setting. Utilizing data from the Integra Connect Database, the researchers quantified the prevalence and frequency of grade ≥ 3 myelosuppressive HAEs and associated healthcare resource utilization (including supportive care such as G-CSFs, ESAs, and blood transfusions), and all-cause hospitalizations.

Key findings included:

Myelosuppressive HAEs

Grade ≥ 3 myelosuppressive HAEs were observed across all regimens in chemotherapy-treated patients (no trilaciclib) with ES-SCLC
Patients treated with chemotherapy alone (no trilaciclib):
57.4% had at least one grade ≥ 3 myelosuppressive HAE
33.3% had grade ≥ 3 thrombocytopenia, 34.0% had grade ≥ 3 anemia, and 44.6% had grade ≥ 3 neutropenia
19.6% had both grade ≥ 3 anemia and grade ≥ 3 thrombocytopenia
20.3% had both grade ≥ 3 neutropenia and grade ≥ 3 anemia
23.0% had both grade ≥ 3 neutropenia and grade ≥ 3 thrombocytopenia
14.5% had grade ≥ 3 HAEs in all three lineages
Patients treated with trilaciclib prior to chemotherapy:
28.6% had at least one grade ≥ 3 myelosuppressive HAE
4.8% had grade ≥ 3 thrombocytopenia, 14.3% had grade ≥ 3 anemia, and 19.0% had grade ≥ 3 neutropenia
0% had both grade ≥ 3 anemia and grade ≥ 3 thrombocytopenia
4.8% had both grade ≥ 3 neutropenia and grade ≥ 3 anemia
4.8% had both grade ≥ 3 neutropenia and grade ≥ 3 thrombocytopenia
No patients had grade ≥ 3 HAEs in all three lineages
Healthcare Resource Utilization (HCRU) for HAE Management:

Patients treated with chemotherapy alone (no trilaciclib):
7.4% were hospitalized between days 8 and 16 after initiation of chemotherapy, and 18.8% were hospitalized between days 1 and 21 after initiation
83.9% received a G-CSF (61.1% within three days after treatment), 10.7% received RBC transfusions, and 2.4% received platelet transfusions at any time after initiation
Patients treated with trilaciclib prior to chemotherapy:
No patients were hospitalized between days 8 and 16 after initiation of chemotherapy, and one was hospitalized between days 1 and 21 after initiation
71.4% received a G-CSF (47.6% within three days after treatment), 4.8% received RBC transfusions, and none received platelet transfusions at any time after initiation

The researchers noted that future studies using data from larger patient populations are recommended to enable a more robust comparison between patients treated with trilaciclib prior to chemotherapy and patients treated with chemotherapy without trilaciclib.

"The myelotoxic impacts of chemotherapy in patients with ES-SCLC — including ≥ grade 3 neutropenia, anemia, and thrombocytopenia — pose a considerable burden to both patients and to the healthcare system at large in terms of associated healthcare resources required to treat them," said Huan Huang, Director of Health Economics and Outcomes Research at G1 Therapeutics and co-author of the study. "While the numbers in the trilaciclib dataset are small, these new data add to a growing body of real-world data cataloguing the extent of this burden in patients with ES-SCLC and the need for innovative therapies, such as trilaciclib, to reduce them."

The results add to data recently published in the Journal of Medical Economics showing the use of trilaciclib prior to first-line chemotherapy resulted in cost savings due to fewer myelosuppressive adverse events and their associated treatment costs in patients with extensive-stage small-cell lung cancer. The data showed that the use of trilaciclib in this setting resulted in a 78% overall reduction in the number of myelosuppressive adverse events and an estimated cost savings per patient were $18,840 from a U.S. payer perspective compared to chemotherapy alone. The findings were derived from a cost-effectiveness analysis based on published literature on myelosuppression and data from the pivotal Phase 2 trilaciclib trial. This manuscript is also available in the scientific publications section of the G1’s website.

On March 31, 2022 Ensysce Biosciences, Inc. ("Ensysce" or the "Company") (NASDAQ: ENSC, OTC: ENSCW), a clinical-stage biotech company applying transformative chemistry to improve prescription drug safety and performance with a current focus on reducing abuse and overdose, reported financial results for the fourth quarter and full year 2021 (Press release, Ensysce Biosciences, MAR 31, 2022, View Source [SID1234611281]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dr. Lynn Kirkpatrick, Chief Executive Officer of Ensysce, commented, "Following the successful completion of our convertible note financing of $15 million, providing the necessary funds to advance our clinical trials, the year concluded with an exceptional Company milestone as the first patients were enrolled in the Phase 1 study of PF614-MPAR, the first product utilizing our MPAR platform designed to reduce drug overdose.

"Subsequently, we initiated and recently concluded, the final dosing in the Bioequivalence (BE) trial of our TAAP opioid, PF614. We believe that the BE study data, expected to be available in the second quarter, will position PF614 as our first commercial candidate, fueling our ability to bring a unique pipeline of products to the market aligned with our mission of helping millions suffering with severe pain."

Dr. Kirkpatrick concluded, "Regarding our financial results, it’s important to note that our net loss for the full year consisted of significant non-cash expenses, including $17.9 million related to fair value accounting for warrants and convertible notes. Cash used in operating activities during 2021 totaled $8.2 million."

TAAP (Opioid Abuse Deterrent Program) Updates

On March 21, 2022, the Company concluded the clinical treatment of the Bioequivalence (BE) portion of the PF614-102 trial, which is studying the novel TAAP opioid, PF614. This followed the successful completion of the multi-ascending twice daily dosing part of the study in December 2021.
BE data from the PF614-102 study is expected to be available by the end of the second quarter 2022. The Company believes that the data will support the 505(b)(2) regulatory path for clinical development of PF614, an abbreviated pathway to FDA approval.
Human abuse liability (HAL) studies to determine labeling claims for PF614 are scheduled to initiate in the second quarter of 2022.
PF614 is designed using the abuse protective platform TAAP, a chemical modification which inactivates the active ingredient in Ensysce’s opioid products, including PF614, until swallowed and exposed to the enzyme trypsin in the digestive system. Our TAAP platform, which we believe provides abuse protection and resistance to manipulation and other forms of recreational drug abuse, should also control the rate of release of the active opioid. The 102 study builds on the safety and pharmacokinetic results of the initial Phase 1 study and is designed to improve the understanding of how PF614 compares to currently available commercial products.
MPAR (Opioid Abuse Deterrent and Overdose Protection Program) Updates

PF614-MPAR-101 Phase 1 study initiated dosing of PF614 in combination with trypsin inhibitor nafamostat and the first subjects successfully completed administration of PF614 followed by PF614 with nafamostat.
The study is continuing with additional subjects enrolling to receive PF614 and nafamostat in various combinations through the third quarter of 2022. Safety and pharmacokinetic results are expected by the end of the third quarter 2022.
Financial Results

Cash – Cash and cash equivalents were $12.3 million as of December 31, 2021, as compared to $0.2 million for the same period in 2020. In the fourth quarter of 2021, Ensysce received funding of $10 million under the convertible note financing, bringing the total cash provided by financing activities in fiscal year 2021 to $20.3 million. Cash used in operating activities in 2021 totaled $8.2 million.

Federal Grants – Funding under federal grants was $1.6 million for the fourth quarter of 2021 compared to $0.4 million in the comparable year ago quarter. For the full year 2021, funding under federal grants was $3.5 million compared to $3.9 million for the same period in 2020. The Company successfully increased clinical development activity with our PF614-MPAR overdose protection product, contributing to an increase in federal grant funding in the fourth quarter of 2021.

Research & Development Expenses – R&D expenses were $2.2 million for the fourth quarter of 2021 compared to $1.3 million in the fourth quarter of 2020 and $4.7 million for the year ended December 31, 2021, compared to $4.4 million for the same period in 2020. The increases for both the quarter and full year were primarily the result of increased external research and development costs related to the clinical programs for PF614 and PF614-MPAR.

General & Administrative Expenses – G&A expenses were $1.5 million for the fourth quarter of 2021 and $0.3 million for the fourth quarter 2020 and $18.7 million for the year ended December 31, 2021, compared to $1.2 million for December 31, 2020. The quarterly increase reflects increased costs from operating as a public company in the 2021 period. The full year increase was primarily driven by $11.6 million of non-cash expense for warrants issued in July 2021 related to a $60.0 million share subscription facility. Also contributing to the increase was $1.3 million of non-cash expense for consultants and $1.1 million expense for commitment fees for the share subscription facility.

Other Income (Expense) – Total other income (expense), net was expense of $8.0 million in the fourth quarter of 2021 and income of $1.1 million in the fourth quarter of 2020. For the full year periods, total other income (expense), net was expense of $9.3 million in 2021 and income of $1.5 million in 2020. The increase in net expenses in the 2021 periods results primarily from non-cash fair value adjustments for the convertible notes and related warrants issued in late 2021, which totaled $6.7 million in the fourth quarter of 2021 and $6.3 million for fiscal year 2021.

Net Income (Loss) – Net loss for the fourth quarter was $10.0 million compared to net income of $18,340 for the comparable year ago period. Net loss was $29.1 million for the year ended December 31, 2021, compared to net loss of $0.2 million for the same period in 2020. As noted above, significant components of the net loss are non-cash expenses. For the fourth quarter, $6.7 million of the $10.0 million net loss was for non-cash fair value adjustments related to the convertible notes issued in September and November 2021. For fiscal year 2021, $17.9 million of the $29.1 million net loss resulted from non-cash expenses for fair value of warrants and convertible notes. As we are a clinical stage biotech company, our research and development of, and regulatory approvals for, our product candidates continues, resulting in expected losses for the foreseeable future.
Additional Company Highlights

Announced the appointment of Dr. Linda Pestano as Chief Development Officer on October 15, 2021, to lead the non-clinical drug development activities.
The Company further strengthened its Board of Directors with the appointment of Ms. Lee Rauch on February 28, 2022.
Completed a $15 million convertible note financing, receiving the second tranche of $10 million on November 5, 2021, after receiving the first tranche of $5 million on September 24, 2021.
Corporate Update Conference Call

Management will host a corporate update conference call on Wednesday, April 6, 2022, at 11:00 a.m. Eastern time. The call will conclude with Q&A from participants.

A playback of the call will be available through May 6, 2022 on Ensysce’s Investor Relations website at ir.ensysce.com.

On March 31, 2022 Allist Pharmaceuticals Co., Ltd., reported that the European Lung Cancer Congress (ELCC) published an abstract detailing results from the FURLONG study, a Phase 3 pivotal trial of Ivesa (Furmonertinib) in a first-line setting of patients with epidermal growth factor receptor (EGFR)-mutated, locally advanced or metastatic non-small cell lung cancer (NSCLC) (Press release, ArriVent Biopharma, MAR 31, 2022, https://arrivent.com/ivesa-demonstrates-progression-free-survival-of-over-20-months-in-first-line-setting-for-egfr-mutated-advanced-nsclc/ [SID1234611280]). The FURLONG study demonstrated that first-line treatment with Ivesa resulted in a median progression-free survival (PFS) of 20.8 months and reduced the risk of disease progression or death by 56% compared to Gefitinib.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The FURLONG study was sponsored by Shanghai Allist Pharmaceuticals Co., Ltd. (hereinafter referred to as "Allist", Stock Code: 688578), and led by Professor Yuankai Shi from Cancer Hospital Chinese Academy of Medical Sciences.

Key Results

FURLONG is a national multi-center, randomized, double-blind, placebo-controlled, Phase 3 study designed to assess the efficacy and safety of Ivesa (Furmonertinib) versus Iressa (Gefitinib) in treatment-naïve patients with locally advanced or metastatic EGFRm NSCLC.

The final results show that the median PFS is significantly prolonged with Ivesa compared to Gefitinib group by 9.7 months (PFS, 20.8 months vs 11.1 months, hazard ratio [HR] 0.44 [95% confidence interval 0.34-0.58], p<0.0001), and the risk of disease progression or death was reduced by 56%. Despite the longer exposure, the incidence of grade ≥ 3 adverse reactions of Ivesa group is still lower than that of the Gefitinib group (11% vs 18%).

The release of breakthrough results of FURLONG study further concluded that first-line Ivesa provided a significant improvement versus the comparator first-generation EGFR-TKI in patients with EGFR-mutated advanced NSCLC. Ivesa is the only third-generation EGFR TKI that showed the primary endpoint PFS value beyond 20 months and the risk of disease progression or death reduced by 56% in a pivotal stage study versus a first-generation EGFR-TKI.

The detail of FURLONG study results will be released in the form of Proffered Paper session at ELCC on March 31, 2022.

Comments from Professor Yuankai Shi, Principal Investigator of FURLONG study, from National Cancer Center/Cancer Hospital Chinese Academy of Medical Sciences:

"Lung cancer is one of the malignant tumors with highest incidence rate and mortality rate in China. The EGFR mutation is the most common driven gene mutation in lung cancer. There is still an unmet clinical demand for the first-line treatment of NSCLC patients harboring EGFR sensitive mutations. The results of the FURLONG study are so exciting that Furmonertinib showed median PFS of 20.8 months as the first line treatment with favorable safety profile, providing an additional and better option for the first-line treatment for patients with locally advanced or metastatic NSCLC harboring EGFR sensitive mutations."