Arvinas, Pfizer announce VERITAC-2 trial did not reach statistical significance
Arvinas (ARVN) and Pfizer (PFE) announced detailed results from the Phase 3 VERITAC-2 clinical trial evaluating vepdegestrant monotherapy versus fulvestrant in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer, MBC, whose disease progressed following prior treatment with cyclin-dependent kinase, CDK, 4/6 inhibitors and endocrine therapy. These data, which were highlighted in the American Society of Clinical Oncology press briefing and selected for Best of ASCO, will be presented today in a late-breaking oral presentation and have been simultaneously published in the New England Journal of Medicine. In the trial, vepdegestrant demonstrated a statistically significant and clinically meaningful improvement in progression-free survival, PFS, among patients with an estrogen receptor 1, ESR1, mutation, reducing the risk of disease progression or death by 43% compared to fulvestrant. The median PFS, as assessed by blinded independent central review, BICR, was 5.0 months with vepdegestrant versus 2.1 months with fulvestrant. Investigator-assessed PFS was consistent with the BICR-assessed PFS. In patients with ESR1 mutations, vepdegestrant demonstrated a consistent PFS benefit over fulvestrant across all pre-specified subgroups. The trial did not reach statistical significance in improvement in PFS in the intent-to-treat population, with a median PFS of 3.7 months for vepdegestrant versus 3.6 for fulvestrant.
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2 hours ago
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Healthy Returns: AstraZeneca, Pfizer, Gilead and other drugmakers release promising cancer drug data at ASCO
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Yahoo
2 hours ago
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Immix Biopharma Announces Primary Endpoint Met in positive NXC-201 Interim Results Presented at ASCO, Enabling Path to Best-in-Class Therapy for relapsed/refractory AL Amyloidosis
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('ImmixBio', 'Company', 'We' or 'Us' or 'IMMX'), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases, today announced meeting its primary endpoint of complete response (CR) rate for cell therapy NXC-201 at an oral presentation of interim results at the 2025 American Society of Clinical Oncology Annual Meeting (ASCO 2025) in Chicago, Illinois. The oral presentation summarized meeting its interim results endpoint in from the U.S. multi-site NEXICART-2 clinical trial evaluating NXC-201 in relapsed/refractory AL Amyloidosis with a data cutoff of April 11, 2025. A Key Opinion Leader (KOL) event to discuss the significance will be held Tuesday, June 3, 2025 3:00pm ET with live Q&A (register here to participate). 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Complete responses (CRs) were observed in 70% (7 out of 10) of patients treated with NXC-201. The remaining 3 patients are bone marrow minimum residual disease (MRD) negative (10-6), predicting future CR (Immix believes remaining three MRD negative (10-6) patients could be confirmed as CRs in the coming weeks and months). Downstream clinical improvement, including cardiac and renal organ responses, were recorded after CRs. There have been no relapses recorded to-date and no safety signals identified. No neurotoxicity has been observed. Only low-grade cytokine release syndrome has been observed. The ASCO presentation contains clinical data as of April 11, 2025. Current treatments typically result in a lower than 10% complete response (CR) rate in relapsed/refractory AL Amyloidosis according to Zanwar, et al 2024, indicating a high unmet medical need. KOL Event to Discuss NXC-201 ASCO Clinical Data PresentationA Key Opinion Leader (KOL) event with lead investigator Heather Landau, MD, of Memorial Sloan Kettering Cancer Center, Shahzad Raza, MD of Cleveland Clinic and Jeffrey Zonder, MD of Karmanos Cancer Center will be held Tuesday, June 3, 2025 at 3:00 pm ET to discuss these results. Register here: About NEXICART-2NEXICART-2 (NCT06097832) is an ongoing single-arm multi-site U.S. Phase 1/2 clinical trial of sterically-optimized CAR-T NXC-201 in relapsed/refractory AL Amyloidosis. NEXICART-2 is expected to enroll 40 patients with preserved heart function (excluding patients with pre-existing heart failure) who have not been exposed to prior BCMA-targeted therapy. The primary endpoint of the Phase 1 portion is safety. The primary endpoint of the Phase 2 portion is efficacy. About NXC-201NXC-201 is a sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy with a 'digital filter' that filters out non-specific activation. Initial data from ex-U.S. study NEXICART-1 has demonstrated high complete response rates in relapsed/refractory AL Amyloidosis. U.S. Phase 1/2 study NEXICART-2 is ongoing. NXC-201 has been awarded Regenerative Medicine Advanced Therapy (RMAT) by the FDA, and Orphan Drug Designation (ODD) by the US FDA and in the EU by the EMA. About AL AmyloidosisAL amyloidosis is caused by abnormal plasma cells in the bone marrow, which produce misfolded amyloid proteins that circulate in the blood, then build-up in the heart, kidney, liver, and other organs. This build-up causes progressive and widespread organ damage, including heart and renal failure, leading to high mortality rates. The U.S. observed prevalence of relapsed/refractory AL Amyloidosis is estimated to be growing at 12% per year according to Staron, et al Blood Cancer Journal, to approximately 33,277 patients in 2024. The Amyloidosis market was $3.6 billion in 2017, and is expected to reach $6 billion in 2025, according to Grand View Research. About Immix Biopharma, Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases. Our lead candidate is sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201. NXC-201 is being evaluated in the U.S. multi-center study NEXICART-2 (NCT06097832). NXC-201 has demonstrated no neurotoxicity in AL Amyloidosis, supporting expansion into other serious diseases. NXC-201 has been awarded Regenerative Medicine Advanced Therapy (RMAT) by the US FDA and Orphan Drug Designation (ODD) by FDA and in the EU by the EMA. Learn more at and Forward Looking StatementsThis press release contains forward-looking statements regarding Immix Biopharma, Inc., its results of operations, prospects, future business plans and operations and the matters discussed above, including, but not limited to, the potential benefits of our product candidate CAR-T NXC-201 and the timing and results related clinical trials. These statements involve risks and uncertainties, and actual results may differ materially from any future results expressed or implied by the forward-looking statements. Forward-looking statements also include, but are not limited to, our plans, objectives, expectations and intentions and other statements that contain words such as 'expects', 'contemplates', 'anticipates', 'plans', 'intends', 'believes', 'estimates', 'potential', and variations of such words or similar expressions that convey the uncertainty of future events or outcomes, or that do not relate to historical matters. Those forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially. Among those factors are: (i) the risk that the further data from the ongoing Phase 1/2 clinical trials for CAR-T NXC-201 will not be favorably consistent with the data readouts to date, (ii) the risk that the Company may not be able to continue the NEXICART-2 multi-site U.S. Phase 1/2 clinical trial; (iii) the risk that the Company may not be able to advance to registration-enabling studies for CAR-T NXC-201 or other product candidates, (iv) that success in early phases of pre-clinical and clinicals trials do not ensure later clinical trials will be successful; (v) that no drug product developed by the Company has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (vi) the risk that the Company may not be able to obtain additional working capital with which to continue the clinical trials for CAR-T NXC-201, or advance to the initiation of registration-enabling studies, for such product candidates as and when needed and (vii) those other risks disclosed in the section 'Risk Factors' included in the Company's Annual Report on Form 10-K filed with the SEC on March 25, 2025 and other periodic reports subsequently filed with the Securities and Exchange Commission. These reports are available at Immix Biopharma cautions that the foregoing list of important factors is not complete. Immix Biopharma cautions readers not to place undue reliance on any forward-looking statements. Immix Biopharma does not undertake, and specifically disclaims, any obligation to update or revise such statements to reflect new circumstances or unanticipated events as they occur, except as required by law. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements. ContactsMike MoyerLifeSci Advisorsmmoyer@ Company Contactirteam@
Yahoo
2 hours ago
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Immix Biopharma Announces Primary Endpoint Met in positive NXC-201 Interim Results Presented at ASCO, Enabling Path to Best-in-Class Therapy for relapsed/refractory AL Amyloidosis
Immix Biopharma today presented results at ASCO from its U.S. multi-center NEXICART-2 Phase 1/2 clinical trial of NXC-201, meeting its primary endpoint. – NXC-201 met primary endpoint with a complete response (CR) rate of 70% (7/10 patients) – – No relapses recorded to-date; no safety signals identified – – Immix plans Biologics License Application (BLA) for FDA approval – – Results were presented by Heather Landau, MD, of Memorial Sloan Kettering Cancer Center – – KOL event to discuss significance Tuesday, June 3, 2025 3:00pm ET after ASCO presentation: – LOS ANGELES, CA, June 03, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. ('ImmixBio', 'Company', 'We' or 'Us' or 'IMMX'), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases, today announced meeting its primary endpoint of complete response (CR) rate for cell therapy NXC-201 at an oral presentation of interim results at the 2025 American Society of Clinical Oncology Annual Meeting (ASCO 2025) in Chicago, Illinois. The oral presentation summarized meeting its interim results endpoint in from the U.S. multi-site NEXICART-2 clinical trial evaluating NXC-201 in relapsed/refractory AL Amyloidosis with a data cutoff of April 11, 2025. A Key Opinion Leader (KOL) event to discuss the significance will be held Tuesday, June 3, 2025 3:00pm ET with live Q&A (register here to participate). 'Meeting primary endpoint at this interim data readout is a testament to the groundbreaking efficacy of NXC-201, as we work toward the first approval in the challenging indication of relapsed/refractory AL Amyloidosis,' said Ilya Rachman, MD, PhD, Chief Executive Officer of Immix Biopharma. Gabriel Morris, Chief Financial Officer of Immix Biopharma, added, 'This inflection point further accelerates our progress toward BLA submission for FDA approval.' Immix's Phase 1/2 NEXICART-2 clinical trial is a U.S. multi-site, single-arm study to evaluate the efficacy and safety of NXC-201 in patients who are refractory to, or relapse on treatment for relapsed/refractory AL Amyloidosis. ASCO Presentation ResultsPrior to NXC-201 treatment, the median lines of therapy was 4 (range: 2-12). All patients had baseline relapsed/refractory AL Amyloidosis organ involvement. After NXC-201 treatment, all patients normalized pathological disease markers. Complete responses (CRs) were observed in 70% (7 out of 10) of patients treated with NXC-201. The remaining 3 patients are bone marrow minimum residual disease (MRD) negative (10-6), predicting future CR (Immix believes remaining three MRD negative (10-6) patients could be confirmed as CRs in the coming weeks and months). Downstream clinical improvement, including cardiac and renal organ responses, were recorded after CRs. There have been no relapses recorded to-date and no safety signals identified. No neurotoxicity has been observed. Only low-grade cytokine release syndrome has been observed. The ASCO presentation contains clinical data as of April 11, 2025. Current treatments typically result in a lower than 10% complete response (CR) rate in relapsed/refractory AL Amyloidosis according to Zanwar, et al 2024, indicating a high unmet medical need. KOL Event to Discuss NXC-201 ASCO Clinical Data PresentationA Key Opinion Leader (KOL) event with lead investigator Heather Landau, MD, of Memorial Sloan Kettering Cancer Center, Shahzad Raza, MD of Cleveland Clinic and Jeffrey Zonder, MD of Karmanos Cancer Center will be held Tuesday, June 3, 2025 at 3:00 pm ET to discuss these results. Register here: About NEXICART-2NEXICART-2 (NCT06097832) is an ongoing single-arm multi-site U.S. Phase 1/2 clinical trial of sterically-optimized CAR-T NXC-201 in relapsed/refractory AL Amyloidosis. NEXICART-2 is expected to enroll 40 patients with preserved heart function (excluding patients with pre-existing heart failure) who have not been exposed to prior BCMA-targeted therapy. The primary endpoint of the Phase 1 portion is safety. The primary endpoint of the Phase 2 portion is efficacy. About NXC-201NXC-201 is a sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy with a 'digital filter' that filters out non-specific activation. Initial data from ex-U.S. study NEXICART-1 has demonstrated high complete response rates in relapsed/refractory AL Amyloidosis. U.S. Phase 1/2 study NEXICART-2 is ongoing. NXC-201 has been awarded Regenerative Medicine Advanced Therapy (RMAT) by the FDA, and Orphan Drug Designation (ODD) by the US FDA and in the EU by the EMA. About AL AmyloidosisAL amyloidosis is caused by abnormal plasma cells in the bone marrow, which produce misfolded amyloid proteins that circulate in the blood, then build-up in the heart, kidney, liver, and other organs. This build-up causes progressive and widespread organ damage, including heart and renal failure, leading to high mortality rates. The U.S. observed prevalence of relapsed/refractory AL Amyloidosis is estimated to be growing at 12% per year according to Staron, et al Blood Cancer Journal, to approximately 33,277 patients in 2024. The Amyloidosis market was $3.6 billion in 2017, and is expected to reach $6 billion in 2025, according to Grand View Research. About Immix Biopharma, Biopharma, Inc. (ImmixBio) (Nasdaq: IMMX) is a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases. Our lead candidate is sterically-optimized BCMA-targeted chimeric antigen receptor T (CAR-T) cell therapy NXC-201. NXC-201 is being evaluated in the U.S. multi-center study NEXICART-2 (NCT06097832). NXC-201 has demonstrated no neurotoxicity in AL Amyloidosis, supporting expansion into other serious diseases. NXC-201 has been awarded Regenerative Medicine Advanced Therapy (RMAT) by the US FDA and Orphan Drug Designation (ODD) by FDA and in the EU by the EMA. Learn more at and Forward Looking StatementsThis press release contains forward-looking statements regarding Immix Biopharma, Inc., its results of operations, prospects, future business plans and operations and the matters discussed above, including, but not limited to, the potential benefits of our product candidate CAR-T NXC-201 and the timing and results related clinical trials. These statements involve risks and uncertainties, and actual results may differ materially from any future results expressed or implied by the forward-looking statements. Forward-looking statements also include, but are not limited to, our plans, objectives, expectations and intentions and other statements that contain words such as 'expects', 'contemplates', 'anticipates', 'plans', 'intends', 'believes', 'estimates', 'potential', and variations of such words or similar expressions that convey the uncertainty of future events or outcomes, or that do not relate to historical matters. Those forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause actual results to differ materially. Among those factors are: (i) the risk that the further data from the ongoing Phase 1/2 clinical trials for CAR-T NXC-201 will not be favorably consistent with the data readouts to date, (ii) the risk that the Company may not be able to continue the NEXICART-2 multi-site U.S. Phase 1/2 clinical trial; (iii) the risk that the Company may not be able to advance to registration-enabling studies for CAR-T NXC-201 or other product candidates, (iv) that success in early phases of pre-clinical and clinicals trials do not ensure later clinical trials will be successful; (v) that no drug product developed by the Company has received FDA pre-market approval or otherwise been incorporated into a commercial drug product, (vi) the risk that the Company may not be able to obtain additional working capital with which to continue the clinical trials for CAR-T NXC-201, or advance to the initiation of registration-enabling studies, for such product candidates as and when needed and (vii) those other risks disclosed in the section 'Risk Factors' included in the Company's Annual Report on Form 10-K filed with the SEC on March 25, 2025 and other periodic reports subsequently filed with the Securities and Exchange Commission. These reports are available at Immix Biopharma cautions that the foregoing list of important factors is not complete. Immix Biopharma cautions readers not to place undue reliance on any forward-looking statements. Immix Biopharma does not undertake, and specifically disclaims, any obligation to update or revise such statements to reflect new circumstances or unanticipated events as they occur, except as required by law. If we update one or more forward-looking statements, no inference should be drawn that we will make additional updates with respect to those or other forward-looking statements. ContactsMike MoyerLifeSci Advisorsmmoyer@ Company Contactirteam@ Sign in to access your portfolio
