Polatuzumab vedotin

Glofitamab-GemOx Shows Survival Benefit in Phase 3 STARGLO Trial for R/R DLBCL, But FDA Advisory Committee Questions US Applicability

3 days ago

• The phase 3 STARGLO trial demonstrated that glofitamab combined with gemcitabine and oxaliplatin nearly doubled median overall survival to 25.5 months compared with 12.9 months for rituximab-GemOx in transplant-ineligible R/R DLBCL patients. • Despite showing a 41% reduction in death risk and 63% reduction in disease progression, the FDA's Oncologic Drugs Advisory Committee voted 8-to-1 against the applicability of the trial data to US patients, citing regional outcome differences. • Glofitamab, a CD20xCD3 bispecific antibody, is currently approved in over 30 countries and has accelerated approval in the US, with an FDA decision on full approval expected by July 20, 2025.

Roche's OCREVUS Shows Strong Efficacy in MUSETTE Phase III Trial for Multiple Sclerosis

2 months ago

• Roche Holding's MUSETTE Phase III trial demonstrated strong efficacy of the approved 600 mg dose of OCREVUS for multiple sclerosis, reinforcing its position in the treatment landscape. • The company has launched a new subcutaneous formulation of OCREVUS, expanding administration options for patients while continuing to build its neuromuscular disease portfolio. • Roche has outperformed both the Swiss market and pharmaceutical industry with a 33.01% total shareholder return over the past year, bolstered by strategic collaborations and regulatory approvals.

FDA Grants Priority Review to Roche's Lunsumio for Follicular Lymphoma Treatment

3 months ago

• The FDA has granted priority review to Lunsumio, Roche's novel T-cell engager targeting CD20 and CD3, with a decision expected by December 29 for relapsed/refractory follicular lymphoma treatment. • Clinical trials demonstrated impressive efficacy with an 80% overall response rate and 60% complete responses in third-line or later therapy, comparable to existing CAR-T cell therapies. • As an off-the-shelf outpatient treatment, Lunsumio offers significant advantages over CAR-T therapies by eliminating manufacturing delays and the need for hospitalization.

Tambiciclib-Zanubrutinib Combo Shows 67% Response Rate in Relapsed/Refractory DLBCL Trial

3 months ago

• Phase 2a trial demonstrates promising 67% overall response rate for tambiciclib plus zanubrutinib combination in relapsed/refractory DLBCL patients, including one complete response. • The combination therapy showed particularly strong efficacy in ABC DLBCL subtype patients, achieving an 83% disease control rate with 4 responses and 1 stable disease out of 6 patients. • Safety profile reveals grade 3 or higher adverse effects in 55.6% of patients, while genetic analysis indicates efficacy independent of MYD88 or CD79B mutations.

Novel Approaches Reshape Lymphoma Treatment Landscape: Bispecific Antibodies and MRD-Guided Therapy Show Promise

4 months ago

• Bispecific antibodies demonstrate remarkable response rates in both diffuse large B-cell and follicular lymphoma, with promising durability in frontline treatment settings. • Groundbreaking ECOG-ACRIN trial reveals MRD-negative mantle cell lymphoma patients may not require stem cell transplantation, potentially changing decades of standard practice. • Research initiatives are expanding to include older lymphoma patients and focus on quality-of-life outcomes, with new trial designs better reflecting real-world patient populations.

Innovent and Roche Partner to Develop DLL3-Targeted ADC for Small Cell Lung Cancer

5 months ago

• Innovent Biologics and Roche have entered an exclusive license agreement to develop IBI3009, an antibody-drug conjugate (ADC) targeting delta-like ligand 3 (DLL3) for advanced small cell lung cancer. • Roche gains worldwide rights for development, manufacturing, and commercialization, assuming full responsibility after early-stage development, with Innovent receiving an $80 million upfront payment. • IBI3009 has shown encouraging anti-tumor activity and a favorable safety profile in preclinical studies, with Phase I trials already underway in the US, China, and Australia. • This collaboration leverages Roche's expertise in ADCs and Innovent's innovative approach to address unmet needs in treating solid tumors, particularly small cell lung cancer.

Roche's Bispecific Antibodies Columvi and Lunsumio Show Durable Remissions in Lymphoma Patients

5 months ago

• Long-term data confirm that fixed-duration Columvi and Lunsumio achieve lasting remissions beyond treatment, potentially reducing travel burden due to less frequent dosing. • Subcutaneous administration of Lunsumio demonstrates non-inferiority to intravenous treatment with a consistent safety profile, offering a shorter administration time. • Columvi combined with Polivy shows high response rates in relapsed/refractory large B-cell lymphoma, including those previously treated with CAR T-cell therapy. • These results support Roche's efforts to provide diverse treatment options for lymphoma patients, improving treatment standards and patient experience.

Lisocabtagene Maraleucel Shows Promise in Relapsed/Refractory Lymphomas

5 months ago

• Lisocabtagene maraleucel (liso-cel) demonstrates efficacy and safety in second-line treatment of relapsed/refractory large B-cell lymphoma (LBCL), aligning with pivotal trial outcomes. • The TRANSCEND FL trial indicates liso-cel achieved a significant overall response rate in relapsed/refractory marginal zone lymphoma (MZL), meeting the primary endpoint. • Five-year data from TRANSCEND-NHL-001 underscore the curative potential of liso-cel in third-line LBCL, showing a 38% overall survival rate. • Real-world data supports liso-cel's effectiveness across diverse LBCL patient subgroups, reinforcing its role as a standard-of-care treatment option.

Merck's Zilovertamab Vedotin Shows Promise in Phase 2 DLBCL Trial, Phase 3 Initiated

5 months ago

• Merck's zilovertamab vedotin, combined with R-CHP, achieved a 100% complete response rate in previously untreated DLBCL patients in a Phase 2 trial. • The 1.75 mg/kg dose of zilovertamab vedotin was established as the recommended dose for the Phase 3 trial based on efficacy and safety. • A Phase 3 trial, waveLINE-010, has been initiated to evaluate zilovertamab vedotin plus R-CHP versus R-CHOP in previously untreated DLBCL patients. • The waveLINE-010 trial aims to enroll 1,046 patients globally, with progression-free survival as the primary endpoint.

Polivy Combination Therapy Shows Sustained Benefit in Aggressive Lymphoma

5 months ago

• Five-year follow-up data from the POLARIX study shows a positive trend in overall survival for patients with previously untreated diffuse large B-cell lymphoma (DLBCL) treated with Polivy in combination with R-CHP. • Patients receiving Polivy with R-CHP required approximately 25% fewer subsequent treatments like radiation or CAR-T cell therapy, potentially reducing healthcare burdens. • The progression-free and disease-free survival benefits of Polivy plus R-CHP were maintained, reinforcing its potential for durable remissions in DLBCL. • The safety profile of the Polivy combination remained consistent, with no new safety signals, supporting its favorable benefit-risk profile.

FDA Accepts sBLA for Glofitamab Plus Chemotherapy in Relapsed/Refractory DLBCL

6 months ago

• The FDA has accepted Roche's sBLA for glofitamab combined with gemcitabine and oxaliplatin (GemOx) for relapsed/refractory DLBCL patients ineligible for autologous stem cell transplant. • The sBLA is based on the phase 3 STARGLO trial, which demonstrated a statistically significant and clinically meaningful improvement in overall survival compared to rituximab plus GemOx. • The FDA is expected to make a decision on the approval of glofitamab in combination with GemOx by July 20, 2025, offering a potential new treatment option. • The safety profile of glofitamab plus GemOx was consistent with the known safety profiles of the individual agents, with cytokine release syndrome being a common adverse event.

Antibody-Drug Conjugates Market Surpasses $10 Billion, Driven by Lung and Breast Cancer Therapies

7 months ago

• The antibody-drug conjugates (ADCs) market has exceeded US$10 billion in 2023, demonstrating its commercial viability in cancer therapeutics. • Lung cancer is witnessing the most extensive ADC development with over 60 candidates in clinical trials, addressing a high unmet medical need. • Breast cancer has the highest number of ADC approvals to date, with key players like Kadcyla and Enhertu achieving significant sales milestones. • The US and China lead the ADC market, driven by robust healthcare infrastructure, R&D expenditure, and increasing government support.

Roche Highlights Advances in Blood Disorder Treatments at ASH 2024

7 months ago

• Roche will present over 40 abstracts at the 66th ASH meeting, showcasing advancements in lymphoma and other blood disorders, reinforcing their commitment to hematology. • Five-year data from the POLARIX study shows a positive trend in overall survival for first-line diffuse large B-cell lymphoma (DLBCL) patients treated with Polivy in combination with R-CHP. • Extended follow-up data from studies of Lunsumio and Columvi demonstrate long-lasting remissions and immune system recovery in follicular lymphoma and DLBCL, respectively. • Data on subcutaneous Lunsumio shows high response rates and low cytokine release syndrome, potentially improving patient experience with shorter administration times.

Genentech Presents Promising Blood Disorder Data at ASH 2024

7 months ago

• Genentech presented data at ASH 2024 highlighting advancements in lymphoma treatment with Polivy, Lunsumio, and Columvi, showcasing durable remissions and overall survival benefits. • Five-year data from the Phase III POLARIX study showed a positive trend in overall survival for first-line diffuse large B-cell lymphoma (DLBCL) patients treated with Polivy combination therapy. • Extended follow-up data from studies of Lunsumio and Columvi demonstrated long-lasting remissions and immune system recovery, supporting their use as fixed-duration bispecific antibodies. • New data on subcutaneous Lunsumio showed high response rates and low cytokine release syndrome, potentially improving patient experience with shorter administration times.

Genentech Highlights Long-Term Data Across Hematology Portfolio at ASH 2024

7 months ago

• Genentech will present over 40 abstracts at the ASH Annual Meeting, showcasing advancements in lymphoma and other blood disorders. • Five-year data from the POLARIX study shows Polivy, combined with R-CHP, has a positive trend in overall survival for DLBCL patients. • Extended follow-up data of Lunsumio and Columvi demonstrate long-lasting remissions and immune system recovery in follicular lymphoma and DLBCL. • Subcutaneous Lunsumio shows high response rates and low CRS rates, potentially improving patient experience with shorter administration times.

Genentech Presents Encouraging Long-Term Data for Lymphoma and Hemophilia Treatments

7 months ago

• Genentech's Polivy, in combination with R-CHP, demonstrates sustained benefits in diffuse large B-cell lymphoma (DLBCL) after five years. • Lunsumio shows high durable response rates and a manageable safety profile in relapsed/refractory follicular lymphoma, even after multiple prior therapies. • Columvi maintains durable responses in relapsed/refractory large B-cell lymphoma, including high-grade B-cell lymphoma, with extended follow-up. • Hemlibra demonstrates effective bleed control in infants with hemophilia A, from birth to 12 months, according to exploratory analysis of the HAVEN 7 study.

Pharma Update: Regulatory Approvals, Clinical Data, and Strategic Moves

7 months ago

• The FDA has approved Pfizer's Abrysvo for RSV in adults under 60 at increased risk, making it the only RSV vaccine for this age group. • Novo Nordisk's oral semaglutide (Rybelsus) demonstrated a 14% reduction in major adverse cardiovascular events in type 2 diabetes patients. • Sanofi is in talks to sell a controlling stake in its consumer healthcare business, Opella, valuing it at approximately 16 billion euros. • The EMA's CHMP recommended approval of AstraZeneca's Wainzua for hereditary transthyretin-mediated amyloidosis (ATTRv-PN).

Radiopharmaceutical Antibody-Drug Conjugates (rADCs) Emerge as Promising Cancer Therapies

9 months ago

• rADCs are designed to deliver radiation directly to cancer cells, minimizing side effects compared to traditional radiation therapy. • Several companies are developing rADCs with various radioisotopes and antibodies, targeting cancers like prostate, breast, and lung cancer. • Clinical trials are underway to assess the efficacy and safety of rADCs, showing promising results in reducing tumor markers like PSA. • Challenges remain in supply chain logistics, dosimetry, and optimizing drug delivery to target tissues for effective cancer treatment.

Bridging Therapy Before Axi-Cel Doesn't Improve Outcomes in LBCL, Real-World Data Shows

a year ago

• A real-world study found that bridging therapy before axicabtagene ciloleucel (axi-cel) for relapsed/refractory large B-cell lymphoma (LBCL) did not significantly improve efficacy or safety outcomes. • Patients receiving bridging therapy had a 70% overall response rate (ORR) with axi-cel, compared to 79% in those without; complete response (CR) rates were 51% and 64%, respectively. • After adjusting for imbalances, no significant differences in ORR, progression-free survival (PFS), or overall survival (OS) were observed between the bridging and non-bridging therapy groups. • Responses to bridging therapy may indicate anticipated outcomes after axi-cel, with patients responding to bridging showing improved CRs, PFS, and OS post-axi-cel infusion.

Polatuzumab vedotin

Drug Development Updates