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Roche’s divarasib shows superiority in head-to-head phase III trial against approved KRAS G12C inhibitors in non-small cell lung cancer

On July 2, 2026 Roche (SIX: RO, ROP; OTCQX: RHHBY) reported positive results from the phase III Krascendo 1 study evaluating divarasib, an investigational next-generation KRAS G12C inhibitor, against the approved, first generation KRAS G12C inhibitors sotorasib or adagrasib in patients with previously treated KRAS G12C non-small cell lung cancer (NSCLC). The study met its primary and key secondary endpoint, with divarasib achieving clinically meaningful and statistically significant improvements in both progression-free survival (PFS) and overall survival (OS). The safety profile for divarasib remained consistent with previous data, with no new findings detected and the most common treatment-related events being manageable and reversible.

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"The superior survival demonstrated in this global head-to-head comparison of KRAS G12C inhibitors confirms the potential of divarasib to improve clinical outcomes for people with KRAS G12C non-small cell lung cancer," said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. "These results should establish divarasib as a new standard of care for previously-treated lung cancer patients with this genetically defined tumor subtype."

Efficacious treatments for KRAS G12C NSCLC represent a significant unmet need in lung cancer care. The G12C mutation is one of the most common KRAS oncogene mutations, found in approximately 14% of NSCLC cases and associated with poor prognosis for patients.1,2

Roche is advancing a comprehensive phase III clinical development programme in NSCLC, investigating divarasib as both a monotherapy and as a chemotherapy-free combination, across different disease settings and lines of therapy. The US Food and Drug Administration granted Breakthrough Therapy Designation to divarasib in 2022, and in 2026, Orphan Drug Designation for KRAS G12C non-small cell lung cancer (NSCLC).

Data from the Krascendo 1 study will be presented at an upcoming medical meeting and submitted to health authorities with the aim of bringing this potential treatment option to people with KRAS G12C NSCLC as soon as possible.

About Krascendo 1
The Krascendo 1 study [NCT06497556] is the only global head-to-head study evaluating a Kirsten rat sarcoma virus (KRAS) G12C inhibitor in direct comparison with first generation KRAS G12C inhibitors.3 This phase III, randomised, open-label, multicentre study evaluates the efficacy and safety of divarasib monotherapy versus sotorasib or adagrasib in people with previously treated KRAS G12C-mutant advanced or metastatic non-small cell lung cancer.3 The study includes 338 adults, randomised to receive either divarasib (once daily) or, either sotorasib (once daily) or adagrasib (twice daily).3 The primary endpoint is blinded independent central review (BICR)-assessed progression-free survival.3 Secondary endpoint measures include overall survival, confirmed objective response, duration of response, as well as other efficacy and safety measures.3

About divarasib
Divarasib is an investigational, next-generation, oral, KRAS G12C inhibitor. It has shown greater potency and selectivity in preclinical studies compared with first generation KRAS G12C-targeting treatments, sotorasib and adagrasib.4,5 Divarasib is designed to selectively bind to the KRAS G12C protein, locking the protein in an inactive (‘off’) state, thereby turning off its tumour-driving signalling.6

Divarasib’s comprehensive clinical development programme is anchored by three phase III studies:

Study Intervention Patient population
Krascendo 1
[NCT06497556] Divarasib monotherapy vs sotorasib or adagrasib Previously treated KRAS G12C-mutant advanced or metastatic NSCLC (second-line)
Krascendo 2
[NCT06793215] Divarasib plus pembrolizumab
(chemotherapy-free combination) vs chemotherapy plus pembrolizumab Previously untreated KRAS G12C-mutant advanced NSCLC (first-line)
Krascendo 3
[NCT07541170] Adjuvant divarasib monotherapy vs immunotherapy or observation Resected stage II–IIIB KRAS G12C-mutant NSCLC after standard of care chemoimmunotherapy (early-stage)
About KRAS G12C non-small cell lung cancer
Despite advances in treatment, lung cancer remains the leading cause of cancer-related deaths worldwide, surpassing the combined mortality rates of breast, prostate, and stomach cancers.7,8 Each year, it claims the lives of 1.8 million people, with non-small cell lung cancer (NSCLC) accounting for approximately 85% of cases.7,9 KRAS is one of the most frequently mutated genes in lung cancer, occurring in approximately 25% of newly diagnosed lung cancers.10 The G12C mutation is one of the most common KRAS mutations, found in approximately 14% of NSCLC cases.1

The KRAS gene produces the KRAS protein, which acts as a cellular control switch, cycling between an active (‘on’) and inactive (‘off’) state to regulate cell growth and proliferation, making it a critical target for new therapeutic strategies.10 The G12C mutation locks the KRAS protein in its active (‘on’) state, leading to continuous, unregulated signalling for cell growth, driving tumour proliferation.

(Press release, Hoffmann-La Roche, JUL 2, 2026, View Source [SID1234669051])

Alligator announces first patient dosed in investigator-initiated study of intratumoral mitazalimab in early-stage breast cancer

On July 2, 2026 Alligator Bioscience (Nasdaq Stockholm: ATORX), a clinical-stage biotechnology company developing tumor-directed immuno-oncology antibody drugs, reported that the first patient has been dosed in an investigator-initiated trial (IIT, NCT07319195) evaluating intratumoral administration of mitazalimab, Alligator’s lead CD40 agonist, in patients with early-stage breast cancer. The study will evaluate mitazalimab given as a single intratumoral dose, either alone or in combination with a single intratumoral dose of the PD-1 inhibitor nivolumab, prior to surgery.

While checkpoint inhibitors have improved outcomes in some breast cancer subtypes, there remains a need for more effective and better-tolerated immunotherapy approaches in others. In a recent publication in NPJ Breast Cancer, Dr Zhang has demonstrated that CD40 agonists synergize with PD-1 inhibitor in preclinical breast cancer models eradicating tumors and providing long lasting tumor immunity. This IIT will explore if local CD40 activation can enhance anti-tumor immunity in resectable breast cancer, and generate translational insights to guide further randomized trials.

The primary endpoints are safety and feasibility of administering mitazalimab, with or without nivolumab, prior to surgery. Secondary and exploratory objectives include pathologic and imaging-based measures of anti-tumor activity and translational analyses intended to characterize immune activation in the tumor microenvironment.

"We are pleased to support this investigator-initiated trial evaluating intratumoral mitazalimab in early-stage breast cancer. Breast cancer is the most common cancer in women, and the leading cause of cancer-related death. said Søren Bregenholt, CEO of Alligator Bioscience. As the biology and treatment of breast cancer varies significantly from that of pancreatic cancer this trial has the potential to generate valuable new translational insights that can guide future development to expand the clinical utility of mitazalimab."
About investigator-initiated trials
Investigator-initiated trials (IITs) are sponsored and executed by clinical investigators, with Alligator’s consent, but without our direct involvement besides supplying mitazalimab, providing scientific input and ensuring certain aspects of clinical safety reporting. IITs offer the opportunity to strengthen our understanding of mitazalimab’s mechanism of action, expand its potential use beyond pancreatic cancer, and explore additional indications to support further development. Alligator announces the initiation of an IIT once the first patient has been dosed with mitazalimab, and shares key outcomes and milestones, but does not commit to provide regular updates on individual trials.

(Press release, Alligator Bioscience, JUL 2, 2026, View Source [SID1234669050])

Fate Therapeutics to Participate in Upcoming Third Quarter 2026 Conferences

On July 1, 2026 Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to bringing a transformative pipeline of induced pluripotent stem cell (iPSC)-derived cellular immunotherapies to patients with cancer and autoimmune diseases, reported that management will participate in the following investor conferences in the third quarter of 2026.

Leerink Partners Therapeutics Forum

Location: Boston, MA

Date: July 14th & 15th

Wells Fargo 21st Annual Healthcare Conference

Location: Boston, MA

Date: September 8th – 10th

12th Annual Cantor Fitzgerald Global Healthcare Conference

Location: New York, NY

Date: September 9th – 11th

H.C. Wainwright 28th Annual Global Investment Conference

Location: New York, NY

Date: September 14th – 16th

The Company may participate in a presentation or a fireside chat at these conferences. When available, a live webcast will be accessible under "Events & Presentations" in the Investors section of the Company’s website at www.fatetherapeutics.com. An archived replay of the webcast will be available for 30 days on the Company’s website following the event.

(Press release, Fate Therapeutics, JUL 1, 2026, View Source [SID1234669049])

Alvotech further strengthens liquidity by securing term loan facility of $75 million

On July 1, 2026 Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, reported that it has amended its existing credit agreement with funds managed by GoldenTree Asset Management LP and other existing lenders of Alvotech to provide a term loan facility of up to $75 million in additional capital.

The financing further strengthens Alvotech’s financial position following the $165 million equity capital raise announced on June 18, 2026, and supports the continued execution of the company’s growth strategy, including advancing its biosimilar pipeline, supporting product launches and expanding global commercial operations. Including the equity financing and the undrawn term loan facility the company has secured access to $240 million in new capital.

"This financing provides additional flexibility as we continue to execute on our strategic priorities and support the next phase of growth for Alvotech," said Robert Wessman, founder and chairman of Alvotech. "The strong support we received from both existing shareholders and more than 40 new specialist healthcare investors in our recent equity offering, together with this additional financing, reflects growing confidence in Alvotech, our strategy and the opportunities ahead.

"Over the past several months we have achieved important milestones across our business, including the resubmission of key Biologics License Applications to the FDA, continued advancement of our pipeline including FDA acceptance of our BLA for a biosimilar to Entyvio, and the expansion of our global commercial footprint. These achievements reinforce our belief that we are building one of the world’s leading biosimilars companies.

"With approximately 30 biosimilar products in development and a growing portfolio of commercial opportunities, we see a significant opportunity to increase patient access to affordable biologic medicines around the world.

"Capital is the fuel that enables us to execute on that vision, and this financing further strengthens our ability to invest in growth and create long-term value for patients, partners and shareholders."

The financing builds on Alvotech’s existing relationship with GoldenTree, which has been a long-term financing partner to the company. It expands the company’s existing credit agreement by providing an additional $75 million term loan facility alongside the $100 million term loan facility announced in December 2025. It bears an interest rate of 12.50%, payable monthly in cash, and has a maturity date of December 31, 2027.

(Press release, Alvotech, JUL 1, 2026, View Source [SID1234669048])

FDA Alignment to Advance ProstACT Global Phase 3 Trial

On July 1, 2026 Telix Pharmaceuticals (ASX: TLX, NASDAQ: TLX, "Telix") reported the successful outcome of a Type B meeting with the United States (U.S.) Food and Drug Administration (FDA) to review the Part 1 safety and dosimetry data and Part 2 protocol design of the ProstACT Global Phase 3 trial of its therapeutic candidate TLX591-Tx (lutetium-177 (177Lu) rosopatamab tetraxetan) in metastatic castration resistant prostate cancer.

The FDA has confirmed that the safety data from Part 1 of the study is sufficient to enable progression of Part 2 of ProstACT Global into the U.S. in which TLX591-Tx is administered in two doses, 14 days apart, in combination with one of three randomized standard of care (SOC) therapies: abiraterone, enzalutamide or docetaxel. The FDA and Telix also achieved alignment on the Part 2 clinical trial protocol, statistical analysis plan, and ongoing safety monitoring plan. The result is a consistent framework for study execution as enrollment continues internationally and expands into the U.S.

David N. Cade, MD, Group Chief Medical Officer, Telix, said, "This is an excellent outcome that enables submission of our IND amendment for initiation of Part 2 of ProstACT Global in the U.S. Part 2 continues to enroll strongly in regions where recruitment is open."

Neeraj Agarwal, MD, Professor of Medicine and Presidential Endowed Chair of Cancer Research at Huntsman Cancer Institute, Salt Lake City, and ProstACT Global Principal Investigator and Steering Committee member, commented, "TLX591-Tx has the potential to redefine how radiopharmaceutical therapy is integrated into clinical practice. Because the complete treatment course is delivered over approximately two weeks, physicians can layer it into an existing regimen with minimal interruption, providing greater flexibility to sequence therapies while preserving future treatment options in patients with metastatic prostate cancer."

Initiation of Part 2 in the U.S. remains subject to the FDA’s review of an Investigational New Drug (IND) amendment. The IND amendment will also be aligned with a pending regulatory submission to initiate the ProstACT Global study in Europe. The trial continues to enroll patients in regions where Part 2 is approved1.

About ProstACT Global

ProstACT Global (ClinicalTrials.gov ID: NCT06520345) is an international, multicenter trial in two parts: Part 1, safety and dosimetry lead-in with 36 patients (complete); and Part 2, 2:1 randomized global expansion with an overall target enrollment of approximately 490 patients. Eligible patients must have confirmed progressive mCRPC assessed with a 68Ga-PSMA-11 PET2 imaging agent (such as Illuccix, kit for the preparation of gallium-68 (68Ga) gozetotide injection, or Gozellix, kit for the preparation of gallium-68 (68Ga) gozetotide injection) following prior treatment with one ARPI.

The antibody-based approach demonstrates differentiated targeting and pharmacology to other PSMA-targeted small molecule radioligand therapies (RLT). In contrast to these therapies3, collective long-term follow-up of patients administered with TLX591-Tx has not observed significant acute or delayed kidney toxicity, as the agent is hepatically (liver) excreted, a comparatively radioresistant organ4. TLX591-Tx also demonstrates minimal salivary and lacrimal gland uptake, reducing the prevalence of xerostomia (dry mouth) and dry eye, which are typical adverse effects of existing PSMA-targeted RLTs5. Additional information on the Phase 3 ProstACT Global study can be found at: View Source

(Press release, Telix Pharmaceuticals, JUL 1, 2026, View Source [SID1234669047])