Kura Oncology Reports Darlifarnib Plus Cabozantinib Demonstrates Robust Activity in Patients With Clear Cell Renal Cell Carcinoma Previously Treated With Cabozantinib
Rhea-AI Summary
Kura Oncology (Nasdaq: KURA) reported preliminary subset data (N=16) showing the combination of darlifarnib plus cabozantinib produced a 44% objective response rate and 94% disease control rate in cabozantinib‑pretreated clear cell renal cell carcinoma (ccRCC) patients.
Tumor shrinkage occurred in 75% of patients, reductions ranged 32%–47% among responders, treatment durations reached 56 weeks, and six patients remained on therapy at data cut‑off. Safety was described as manageable across dose levels.
Positive
- ORR 44% in cabozantinib‑pretreated ccRCC patients (N=16)
- DCR 94% across all doses tested in the subset
- Tumor shrinkage 75% of patients with reductions 32%–47%
- Durable treatment durations up to 56 weeks
- Six patients remained on therapy at data cut‑off
Negative
- Small subset size of N=16, limiting statistical confidence
- Data are preliminary and from a subset analysis, requiring confirmation
- No randomized or comparative data reported to confirm resensitization claim
News Market Reaction – KURA
In the Apr 17 session, KURA gained 8.28%, reflecting a notable positive market reaction. Argus tracked a peak move of +11.0% during that session. Our momentum scanner triggered 31 alerts that day, indicating elevated trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Apr 09 | Clinical data preview | Positive | +0.7% | Announced upcoming IKCS Europe 2026 presentation of encouraging FIT-001 RCC data. |
| Mar 06 | Equity compensation | Neutral | +5.3% | Reported inducement stock option grants to new employees under 2023 plan. |
| Mar 05 | Earnings and update | Positive | -0.5% | Q4 and 2025 results with KOMZIFTI approval, revenue, cash and pipeline progress. |
| Feb 26 | Earnings date notice | Neutral | +1.1% | Announced timing and webcast details for Q4 and full-year 2025 results. |
| Feb 25 | Investor conferences | Neutral | +2.1% | Outlined participation in three March 2026 healthcare investor conferences. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent news reactions mostly aligned with the underlying tone; one earnings update with generally positive fundamentals saw a small negative reaction, but other operational and corporate updates have tracked positively.
Over the last few months, Kura has transitioned into a commercial-stage oncology company while advancing its pipeline. An IKCS Europe 2026 preview on Apr 9 highlighted encouraging FIT-001 data in cabozantinib-pretreated RCC patients. Earlier, Q4 and full-year 2025 results on Mar 5 detailed initial KOMZIFTI revenue and strong cash resources. Governance and investor-relations events, including conference participation and the earnings-date announcement, rounded out the news flow. Today’s detailed RCC subset results build directly on the April 9 data preview and prior FIT-001 updates.
Key Terms
objective response rate medical
disease control rate medical
clear cell renal cell carcinoma medical
VEGF TKI medical
VEGFR-targeted therapies medical
phase 1b medical
renal cell carcinoma medical
farnesyl transferase inhibitor medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Data from subset analysis of cabozantinib-pretreated patients support potential to overcome resistance and resensitize tumors to VEGF TKI therapy
Responses observed in heavily pretreated patients, including those with stable disease on prior cabozantinib
Durable treatment durations reaching 56 weeks, with one-third of patients remaining on therapy at time of data cut-off
Manageable safety and tolerability profile in all RCC patients across multiple dose levels
Virtual investor event today, April 17, 2026, at 7:30 a.m. PT / 10:30 a.m. ET / 4:30 p.m. CEST
SAN DIEGO and PARIS, April 17, 2026 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a biopharmaceutical company focused on precision medicines for the treatment of cancer, today announced new preliminary data from a subset analysis of patients with clear cell renal cell carcinoma (ccRCC) previously treated with cabozantinib in the ongoing FIT-001 clinical trial (NCT06026410) of darlifarnib (KO-2806) in combination with cabozantinib. Results were presented at the 2026 International Kidney Cancer Symposium (IKCS): Europe in Paris, France.
The analysis specifically evaluated patients with ccRCC who had previously received cabozantinib, a population that typically derives limited benefit from subsequent therapy. In this setting, the combination of darlifarnib and cabozantinib demonstrated robust antitumor activity along with a manageable safety profile as demonstrated in all RCC patients across multiple dose levels, including full dose cabozantinib. These findings are consistent with clinical and preclinical data presented at the 2025 European Society for Medical Oncology (ESMO) and in earlier data disclosures supporting the potential of darlifarnib to enhance the activity of VEGFR-targeted therapies and to address mechanisms of resistance.
Clinical Activity in Cabozantinib-Pretreated Patients (N=16):
- Objective response rate (ORR) was
44% , with a disease control rate (DCR) of94% across all doses tested in this population - Tumor shrinkage observed in
75% of patients, with reductions ranging from32% to47% among responders - Antitumor activity observed in a heavily pre-treated, cabozantinib-exposed population, including patients whose best response to prior cabozantinib was stable disease
- Responses observed in patients previously treated with cabozantinib in the immediate prior line as well as those who had received other TKIs in addition to cabozantinib
- Treatment durations ranged from 8 to 56 weeks, with six patients remaining on therapy at the time of data cutoff
These findings are notable given that patients who progress on cabozantinib are generally considered unlikely to respond to subsequent cabozantinib therapy.
“Patients with advanced ccRCC whose disease progresses on cabozantinib have limited treatment options,” said Adanma Ayanambakkam, M.D., M.S., Assistant Professor of Hematology Oncology Director of Genitourinary Medical Oncology Research, Stephenson Cancer Center, University of Oklahoma Health Sciences Center. “The tumor shrinkage and high disease control rate observed with darlifarnib in combination with cabozantinib suggest this approach may offer meaningful clinical benefit in a refractory setting or in patients with disease progression after therapy.”
The FIT-001 study is evaluating darlifarnib in patients with RCC at once-daily doses of 3 mg, 5 mg or 8 mg alternating 7 days on and off in combination with cabozantinib at once-daily doses of 60 mg or 40 mg. All patients must have received prior immunotherapy. The study has advanced into Phase 1b dose expansion to assess an optimal biologically active dose for the combination.
“These data highlight the potential of darlifarnib to overcome resistance to prior cabozantinib and enhance the activity of VEGF TKIs in patients with advanced RCC,” said Mollie Leoni, M.D., Chief Medical Officer of Kura Oncology. “We are highly encouraged by these results and are committed to advancing this combination to evaluate further its potential to deliver meaningful benefit for RCC patients.”
2026 IKCS: Europe Presentation
The presentation from 2026 IKCS: Europe is available on Kura’s website at www.kuraoncology.com under the Posters and Presentations tab in the Farnesyl Transferase Inhibition section.
Virtual Investor Event
Kura will host a webcast and conference call today, April 17, 2026, at 7:30 a.m. PT / 10:30 a.m. ET / 4:30 p.m. CEST featuring management and Adanma Ayanambakkam, M.D., M.S., Assistant Professor of Hematology Oncology and Director of Genitourinary Medical Oncology Research, Stephenson Cancer Center, University of Oklahoma Health Sciences Center. The live webcast and replay will be available on the Company’s website at www.kuraoncology.com under the Investors tab in the Events and Presentations section.
About Kura Oncology
Kura Oncology is a biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. Kura’s pipeline of small molecule drug candidates is designed to target cancer signaling pathways and address high-need hematologic malignancies and solid tumors. Kura developed and is commercializing KOMZIFTI™ (ziftomenib), the FDA-approved once-daily, oral menin inhibitor for the treatment of adults with relapsed or refractory NPM1-mutated acute myeloid leukemia, and continues to pioneer advancements in menin inhibition and farnesyl transferase inhibition. For additional information, please visit the Kura website at https://kuraoncology.com/ and follow us on X and LinkedIn.
Forward-Looking Statements
This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include, among other things, statements regarding the potential of darlifarnib to enhance the activity of cabozantinib and other VEGFR-targeted therapies and to address mechanisms of resistance, and the potential of darlifarnib in combination with cabozantinib to offer meaningful clinical benefit to patients with RCC. Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Kura may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings, and other interactions with regulatory bodies, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “promise,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties Kura faces, please refer to Kura’s periodic and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Kura assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Conflict of Interest Disclosure
Dr. Ayanambakkam's disclosures include consulting or advisory roles with Regeneron, Pfizer Oncology, Astellas Pharma, Bristol Myer Squibb – WINN CDA, Pharmacosmos Therapeutics, Natera Oncology, Foundation Medicine,National Cancer Institute, Native American Center of Cancer Health Excellence, AVEO, Johnson & Johnson, Kura Oncology.
Kura Contact
Investors and Media:
Greg Mann
858-987-4046
gmann@kuraoncology.com
