lifastuzumab vedotin (DNIB0600A) / Roche - LARVOL DELTA

Targeting NaPi2b with a novel dual TOP1i ADC that shows excellent biophysical properties and high efficacy in vivo (AACR 2024) - "In in vitro assays on various target-positive cell lines with different NaPi2b expression levels, the Araris ADC demonstrated nM-potency in cell cytotoxicity assays, similar to the clinical NaPi2b ADCs lifastuzumab vedotin and upifitamab rilsodotin but being much less toxic to target-negative cells. We believe that this concept in combination with a stable payload attachment at low DAR and an excellent exposure may help to develop ADCs with an improved therapeutic index for various solid tumor indications. The initial results indicate that this ADC may overcome the limitations of current clinical programs against NaPi2b and has the potential to be a first-in-class ADC."

Late-breaking abstract • Preclinical • Oncology • Solid Tumor • SLC34A2

NaPi2b-ADC biological rationale and clinical development of upifitamab rilsodotin (UpRi, XMT- 1536) and lifastuzumab vedotin (LIFA) (ESGO 2021) - "Sponsored by Mersana Therapeutics"

Clinical • SLC34A2

[VIRTUAL] NaPi2b-ADC biological rationale and clinical development of upifitamab rilsodotin (UpRi, XMT- 1536) and lifastuzumab vedotin (LIFA) (IGCS 2021) - "Supported by Mersana Therapeutics"

Clinical • Oncology • SLC34A2

Phase Ia Study of Anti-NaPi2b Antibody-Drug Conjugate Lifastuzumab Vedotin DNIB0600A in Non-Small Cell Lung Cancer and Platinum-Resistant Ovarian Cancer Patients. (PubMed, Clin Cancer Res) - "LIFA exhibited dose-proportional pharmacokinetics and an acceptable safety profile, with encouraging activity in PROC patients at the single-agent RP2D of 2.4 mg/kg."

Biomarker • Clinical • Journal • P1 data • Fatigue • Gynecologic Cancers • Hematological Disorders • Infectious Disease • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pain • Pneumonia • Respiratory Diseases • Thoracic Cancer

Phase 1b study of anti-NaPi2b antibody-drug conjugate lifastuzumab vedotin (DNIB0600A) in patients with platinum-sensitive recurrent ovarian cancer. (PubMed, Gynecol Oncol) - "LIFA in combination with carboplatin ± bevacizumab demonstrated acceptable safety and encouraging activity in PSOC patients."

Clinical • Journal • P1 data • Alopecia • Dermatopathology • Fatigue • Gene Therapies • Gynecologic Cancers • Hematological Disorders • Neutropenia • Oncology • Ovarian Cancer • Pain • Pneumonia • Solid Tumor • Thrombocytopenia • SLC34A2

A randomized, open-label, phase 2 study of anti-NaPi2b Antibody-Drug Conjugate (ADC) lifastuzumab (Lifa) vedotin (DNIB0600A) compared to pegylated liposomal doxorubicin (PLD) in patients (Pts) with platinum-resistant ovarian cancer (PROC) (ASCO 2016) - P2, N=95; NCT01991210; Sponsor: Genentech; "The stratified PFS hazard ratio was 0.78 (95% CI: 0.46-1.31, p = 0.34) with a median PFS of 5.3 months (lifa) vs. 3.1 months (PLD) in the ITT population, and 0.71 (95% CI: 0.40-1.26, p = 0.24) with a median PFS of 5.3 months (lifa) vs. 3.4 months (PLD) in NaPi2b-highpatients. The objective response rate was 34% (95% CI: 22-49%, lifa) vs. 15% (95% CI: 7-28%, PLD) in the ITT population, and 36% (95% CI: 22-52%, lifa) vs.14% (95% CI: 6-27%, PLD) in NaPi 2+/3+ patients per RECIST v1.1."

P2 data • Oncology • Ovarian Cancer

Roche: Q1 Sales Results (Roche) - Anticipated NME submission for platinum-resistant ovarian cancer in US in 2018 or later; Anticipated submission for platinum resistant ovarian cancer in EU in 2018 or later 

Anticipated EU regulatory • Anticipated sBLA • Oncology • Ovarian Cancer

Anti-NaPi2b antibody-drug conjugate lifastuzumab vedotin (DNIB0600A) compared to pegylated liposomal doxorubicin in patients with platinum-resistant ovarian cancer in a randomized, open-label, phase II study. (PubMed, Ann Oncol) - P2; "While the response rate for the MMAE-containing ADC was promising, response durations were relatively short, thereby highlighting the importance of evaluating both response rates and duration of response when evaluating ADC's in OC. NCT01991210."

Clinical • Journal • P2 data