On January 19, 2024 Novartis reported data from the Phase III NETTER-2 trial showing that Lutathera (INN: lutetium (177Lu) oxodotreotide / USAN: lutetium Lu 177 dotatate) plus long-acting release (LAR) octreotide reduced the risk of disease progression or death by 72% as first-line therapy in patients with somatostatin receptor-positive (SSTR+) well-differentiated grade 2/3 advanced gastroenteropancreatic neuroendocrine tumors (GEP-NETs) versus high-dose octreotide LAR alone (Press release, Novartis, JAN 19, 2024, View Source [SID1234639366]). Data were presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal (GI) Cancers Symposium.

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!

"These positive results for Lutathera are practice-changing and offer new first-line treatment data for patients who have a significant unmet need. This study confirms the clinical benefit of first-line radioligand therapy for newly diagnosed patients living with these types of advanced GEP-NETs," said Dr. Simron Singh, Associate Professor of Medicine at the University of Toronto and cofounder of the Susan Leslie Clinic for Neuroendocrine Tumours at the Odette Cancer Centre, Sunnybrook Health Sciences Centre, Ontario, Canada. "These findings should instill confidence among physicians in using Lutathera as a first-line treatment for patients with this life-threatening type of cancer."

Efficacy endpoint1 Lutathera plus octreotide LAR vs. high-dose octreotide LAR
Progression-free survival HR 0.28 (95% CI: 0.18, 0.42; p<0.0001)
Median PFS (months) 22.8 month (95% CI: 19.4 -not estimable) vs. 8.5 months (95% CI: 7.7-13.8)
Objective response rate (ORR)* 43% (95% CI: 35.0-51.3) vs. 9.3% (95% CI: 3.8-18.3), p<0.0001
*Assessed via RECIST 1.1
"This is the first positive Phase III trial of a radioligand therapy in the first-line setting, and the overall efficacy and safety results are amongst the most clinically relevant observed to date in this kind of advanced cancer, addressing a significant unmet need for patients with newly diagnosed advanced GEP-NETs," said Jeff Legos, Global Head of Oncology Development at Novartis. "The positive results are a significant advancement and further reaffirm our strategy to research and develop radioligand therapies in earlier lines of treatment or stages of disease to improve outcomes for patients."

No new or unexpected safety findings were observed in the study and data are consistent with the already well-established safety profile of Lutathera1. Most patients (88%) in the Lutathera arm received all four cycles of Lutathera treatment. The most common all-grade AEs (≥20%) for the Lutathera arm vs. control arm were nausea (27.2% vs 17.8%), diarrhea (25.9% vs 34.2%) and abdominal pain (17.7% vs 27.4%), and the most common grade ≥3 AE (>5%) was lymphocyte count decreased (5.4% vs 0%).

NETs are a type of cancer that originate in neuroendocrine cells throughout the body and are commonly considered slow-growing malignancies. However, some NETs are associated with rapid progression and poor prognosis and in many cases, diagnosis is delayed until patients have advanced disease2-4. Even though NETs are a rare (orphan) disease, their incidence has increased over the past several decades2-5 and there is a need for continued research into treatment options for newly diagnosed patients.

The NETTER-2 trial is ongoing for further evaluation of secondary endpoints including overall survival and long-term safety.

About NETTER-2
NETTER-2 (NCT03972488) is an open-label, multi-center, randomized, comparator-controlled Phase III trial assessing whether Lutathera plus octreotide LAR when taken as a first-line treatment can prolong PFS in patients with high-proliferation rate tumors (G2 and G3), compared to treatment with high-dose (60 mg) long-acting octreotide6. Eligible patients were diagnosed with SSTR-positive advanced GEP-NETs within 6 months before enrollment6.

About Lutathera
Lutathera (INN: lutetium (177Lu) oxodotreotide / USAN: lutetium Lu 177 dotatate) is approved in the US for the treatment of adult patients with SSTR-positive GEP-NETs, including those in the foregut, midgut and hindgut, an indication which includes the NETTER-2 population. Lutathera is also approved in Europe for unresectable or metastatic, progressive, well-differentiated (G1 and G2), SSTR-positive GEP-NETs in adults7,8, and in Japan for SSTR-positive NETs.

On January 19, 2024 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that it will hold its fourth-quarter and full-year 2023 sales and earnings conference call with institutional investors and analysts at 9:00 a.m. ET on Thursday, Feb. 1 (Press release, Merck & Co, JAN 19, 2024, View Source [SID1234639365]). During the call, company executives will provide an overview of Merck’s performance for the fourth quarter and outlook for 2024.

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!

Investors, journalists and the general public may access a live audio webcast of the call via this weblink. A replay of the webcast, along with the sales and earnings news release, supplemental financial disclosures, and slides highlighting the results, will be available at www.merck.com.

All participants may join the call by dialing (800) 779-6561 (U.S. and Canada Toll-Free) or (773) 756-4619 and using the access code 5958465.

On January 19, 2024, IDEAYA Biosciences, Inc. (the "Company") entered into an Open Market Sales Agreement (the "Sales Agreement") with Jefferies LLC ("Jefferies"), with respect to an at-the-market offering program under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock, par value $0.0001 per share (the "Common Stock"), having aggregate gross proceeds of up to $350.0 million (the "Shares") through Jefferies as its sales agent (Filing, 8-K, Ideaya Biosciences, JAN 19, 2024, View Source [SID1234639364]).

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!

Under the Sales Agreement, the Company will set the parameters for the sale of Shares, including the number of Shares to be issued, the time period during which sales are requested to be made, limitations on the number of Shares that may be sold in any one trading day and any minimum price below which sales may not be made. Subject to the terms of the Sales Agreement, Jefferies may sell the Shares by any method that is deemed to be an "at the market offering" as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended (the "Securities Act"), including sales made directly on The Nasdaq Global Select Market or any other trading market for the Common Stock. The Company will pay Jefferies a commission of up to three percent (3.0%) of the gross sales proceeds of any Shares sold through Jefferies under the Sales Agreement, and has provided Jefferies with customary indemnification and contribution rights. The Sales Agreement will terminate upon the earlier of (i) the sale of all Shares subject to the Sales Agreement or (ii) termination of the Sales Agreement in accordance with its terms.

Any Shares to be offered and sold under the Sales Agreement will be issued and sold pursuant to the Company’s Registration Statement on Form S-3 (File No. 333-272936), which became automatically effective upon its filing on June 26, 2023. The Company filed a prospectus supplement with the Securities and Exchange Commission on January 19, 2024 in connection with the offer and sale of the Shares pursuant to the Sales Agreement.

The foregoing description of the Sales Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Sales Agreement, a copy of which is furnished as Exhibit 1.1 to this Current Report on Form 8-K (this "Current Report") and is incorporated herein by reference.

Latham & Watkins LLP, counsel to the Company, has issued an opinion to the Company, dated January 19, 2024, relating to the validity of the Shares to be issued and sold pursuant to the Sales Agreement, a copy of which is filed as Exhibit 5.1 to this Current Report.

This Current Report shall not constitute an offer to sell or the solicitation of an offer to buy any Shares, nor shall there be any offer, solicitation or sale of the Shares in any state or country in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or country.

On January 19, 2024 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported the closing of its underwritten public offering of shares of its common stock. Alector sold 10,869,566 shares of its common stock in the offering (Press release, Alector, JAN 19, 2024, View Source [SID1234639363]). Alector has granted the underwriter a 30-day option to purchase up to an additional 1,630,434 shares of its common stock. The gross proceeds to Alector from the offering, before deducting underwriting discounts and commissions and estimated offering expenses, are approximately $75 million.

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!

Cantor Fitzgerald & Co. acted as sole book-running manager for the offering.

The offering was made pursuant to a shelf registration statement on Form S-3 (File No. 333- 270126) that was previously filed with and subsequently declared effective by the Securities and Exchange Commission ("SEC") on May 1, 2023. The offering was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The final prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website at View Source Copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from: Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, NY 10022, or by e-mail at [email protected].

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On January 19, 2024 Imugene Limited (ASX: IMU), a clinical stage immuno-oncology company, reported further details from its poster presentation at the ASCO (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO-GI) currently being conducted in San Francisco (Press release, Imugene, JAN 19, 2024, https://mcusercontent.com/e38c43331936a9627acb6427c/files/39befa96-9c07-f014-8948-4f0774a3ed3b/Imugene_CF33_hNIS_VAXINIA_MAST_Study_Featured_at_ASCO_GI.pdf [SID1234639339]).

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 poster "Oncolytic Virus CF33-hNIS Monotherapy for the Treatment of Gastrointestinal Malignancies" was presented at 11:45am-1:15pm Pacific time on 18 January 2024 during Session A: Cancers of the Esophagus and Stomach and Other GI Cancers.

Dr Daneng Li, from the City of Hope National Comprehensive Cancer Centre presented the poster which detailed background on CF33, the MAST study design, objectives and results observed to date.

Conclusions of the poster presentation included:

Preliminary data from the first three dose levels demonstrates encouraging anti-tumor activity with CF33-hNIS monotherapy, including one patient with cholangiocarcinoma, treated intratumorally, who achieved an immunological complete response (CR) with no known recurrence after one year.
CF33-hNIS monotherapy may be an effective and safe treatment option for GI (gastrointestinal) malignancies and warrants further investigation in biliary tract cancer patients.
Immunological changes in CF33-hNIS responding patients show a robust innate and adaptive immune response known to promote anti-tumor immunity and underscores the immunomodulatory potential of this therapy.
The poster can be downloaded from the Imugene website at: View Source

ASCO-GI is an annual international event highlighting the latest innovative science, strategies, developments and breakthroughs in gastrointestinal cancer treatment. It is estimated that more than 4,000 scientific figures, clinical researchers, academics, oncologists and medical practitioners from around the world attend the event.