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- ||| poziotinib (HM 78136B) / Spectrum, Hanmi, amivantamab (JNJ-61186372) / Genmab, J&J, Tagrisso (osimertinib) / AstraZeneca
#ASCO20 starts in 1 Wk, new data on #EGFR #exon20MT, activity of amivantamab, osimertinib & poziotinib in #NSCLC, ORR~25% for both TKIs, slightly higher ~36% w/ amivantamab. Look fwd to an engaging poster discussion by @DrSteveMartin #LCSM @ZPiotrowskaMD @JSabari @EGFRResisters (Twitter) - May 22, 2020
- Afinitor (everolimus) / Novartis
Organoid based functional test to predict personalized treatment in cholangiocarcinoma (Virtual Meeting II: E-Posters) - May 16, 2020 - Abstract #AACRII2020AACR-II_2192;
While these results correlate well with genomically predicted drug sensitivities, all patients showed additional drug sensitivities beyond those predicted by genomics offering patients additional potential treatment options. This study highlights the importance of functional data in a genetically heterogenous tumor type such as CCA.
- ||| poziotinib (HM 78136B) / Spectrum, Hanmi, Erbitux (cetuximab) / Eli Lilly, EMD Serono
Preclinical: Exciting new data from @yonsei_u & @JanssenUS in @CD_AACR re "amivantamab" in #EGFR exon20ins. The EGFR/MET mAb induces greater response than poziotinib or cetuximab in vivo. 2 dramatic pt responses shown too! More data soon at #ASCO20: https://t.co/a4AlCXSVYw (Twitter) - May 15, 2020
- |||| poziotinib (HM 78136B) / Spectrum, Hanmi, mobocertinib (TAK-788) / Takeda
Clinical: We expect treatment-naive poziotinib & mobocertinib EGFR ex 20 ins pts to do well but that pem/carbo likely to be in these pts' journeys as well. Important to exclude IO from the first-line chemo regimen if the pt has TKI in 2nd-line, right? @PatelOncology @CoreyLangerMD (Twitter) - May 3, 2020
- Herceptin (trastuzumab) / Roche
[VIRTUAL] Characterization of ERBB2 alterations in non-small cell lung cancer. () - Apr 29, 2020 - Abstract #ASCO2020ASCO_5496;
P1, P2
One third of tumors with extracellular domain ERBB2 mutation had EGFR mutation. Tarloxitinib (NCT03805841), trastuzumab deruxtucan (NCT03505719), pyrotinib (NCT02500199), poziotinib (NCT03318939) are just a few of the novel ERBB2 inhibitors available in clinical trials.
- poziotinib (HM 78136B) / Spectrum, Hanmi
[VIRTUAL] Poziotinib shows activity and durability of responses in subgroups of previously treated EGFR exon 20 NSCLC patients. (Poster Board 280) - Apr 29, 2020 - Abstract #ASCO2020ASCO_2369;
P2
Responses were more common in patients with insertions between M766 to D770 of EGFR exon 20. The safety profile was overall consistent with other 2nd generation EGFR TKIs.
- ||| capmatinib (INC280) / Incyte, Novartis, poziotinib (HM 78136B) / Spectrum, Hanmi
Catch this quick summary by @LeciaSequist from the #TargetedTherapy Oral #LungCancer session on poziotinib and capmatinib #AACR20 @OncoAlert #LCSM (Twitter) - Apr 28, 2020
- || Pozenveo (poziotinib) / Assertio
Trial completion date, EGFR exon 20, HER2 exon 20, Metastases: ZENITH20: Phase 2 Study of Poziotinib in Participants With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation (clinicaltrials.gov) - Apr 27, 2020
P2, N=603, Recruiting, Sponsor: Spectrum Pharmaceuticals, Inc
The safety profile was overall consistent with other 2nd generation EGFR TKIs. Trial completion date: Dec 2023 --> May 2023
- ||| poziotinib (HM 78136B) / Spectrum, Hanmi
Adverse events: Yes, my sister was on Poziotinib for a year. The side effects were BRUTAL at times! (Twitter) - Apr 27, 2020
- |||| poziotinib (HM 78136B) / Spectrum, Hanmi
Clinical: Continuing good news for ICAN's exon 20 lung cancer pts today--Xiuning Le, MD, PhD, and Taofeek Owonikoko, MD, PhD gave excellent presentations on #poziotinib at #AACR20. Great session led by NSCLC expert @RamalingamMD Proud that Suresh is an hon chair of ICAN's Exon 20 Group. (Twitter) - Apr 27, 2020
- |||| poziotinib (HM 78136B) / Spectrum, Hanmi
Clinical: Continuing good news for EGFR exon 20 patients--two of our favorites, Xiuning Le, MD, PhD, and Taofeek Owonikoko, MD, PhD discussed insights on #poziotinib at #AACR20. Great session led by EGFR expert @RamalingamMD Proud that Suresh is one of the honorary chairs at @Exon20Group (Twitter) - Apr 27, 2020
- ||| poziotinib (HM 78136B) / Spectrum, Hanmi
Live #AACR20 Tweet from our @OncoAlert 🚨colleague @marinagarassino "The toxicity of #poziotinib is higher than second generation TKI" #LCSM #LungCancer (Twitter) - Apr 27, 2020
- ||| poziotinib (HM 78136B) / Spectrum, Hanmi
Live #AACR20 Tweet by @DMSLung "Poziotinib a promising agent in NSCLC with exon 20 insertion" (Twitter) - Apr 27, 2020
- |||| poziotinib (HM 78136B) / Spectrum, Hanmi
Clinical: Relatively large data set (N=115) in patients with #EGFR #Exon20 of #poziotinib use, results from #ZENITH20-1 @AACR AM RR ~ 15% DCR ~ 68.7% med PFS ~ 4.2 months (2L+) significant AEs #LCSM #AACR20 (Twitter) - Apr 27, 2020
- ||| poziotinib (HM 78136B) / Spectrum, Hanmi
The toxicity of #poziotinib is higher than second generation TKI. This is our experience #AACR (Twitter) - Apr 27, 2020
- |||| poziotinib (HM 78136B) / Spectrum, Hanmi
#AACR20 Poziotinib a promising agent in NSCLC with exon 20 insertion (Twitter) - Apr 27, 2020
- ||||| poziotinib (HM 78136B) / Spectrum, Hanmi
Clinical: Next up at #AACR20 a study of poziotinib in patients with EGFR Exon 20 insertions presented by Dr Le. This variant of EGFR mutated NSCLC tends to be nonresponsive to traditional EGFR TKI's, as is shown dramatically in this KM survival curve. #LCSM (Twitter) - Apr 27, 2020
- || poziotinib (HM 78136B) / Spectrum, Hanmi, Herceptin (trastuzumab) / Roche, paclitaxel / Generic mfg.
Clinical, P1/2 data, Journal: A phase I/II study of poziotinib combined with paclitaxel and trastuzumab in patients with HER2-positive advanced gastric cancer. (Pubmed Central) - Apr 16, 2020
The MTD of poziotinib combined with paclitaxel and trastuzumab was 8 mg/day. This combination yielded promising anti-tumor efficacy with manageable toxicity in previously treated patients with HER2-positive GC.
- poziotinib (HM 78136B) / Spectrum, Hanmi
[VIRTUAL] Poziotinib activity and durability of responses in previously treated EGFR exon 20 NSCLC patients - a Phase 2 study (Virtual Meeting: All Session Times Are U.S. EDT) - Apr 13, 2020 - Abstract #AACRI2020AACR-I_4;
The tumor size reduction combined with long duration of response demonstrated the clinical activity of poziotinib in treating this patient population. We are further optimizing dosing and AE management.
- || poziotinib (HM 78136B) / Spectrum, Hanmi
Clinical, Journal: Metastatic Breast Cancer Patient With Activating HER2 Exon 20 Insertion Mutation With Response to Poziotinib: Case Report of Compassionate Drug Use. (Pubmed Central) - Mar 29, 2020
We are further optimizing dosing and AE management. No abstract available
- || poziotinib (HM 78136B) / Spectrum, Hanmi, TAK-788 / Takeda
Amazing news. A niche space that is filling up with IMP’s at a phenomenal rate. I’ve no experience with this drug. How does tox compare to poziotinib or TAK788? Or indeed other ex20ins agents. (Twitter) - Mar 11, 2020
- ||| Pozenveo (poziotinib) / Assertio
Trial completion date, Trial termination, Trial primary completion date, Combination therapy, Metastases: A Study of Poziotinib in Combination With T-DM1 in HER2-Positive Breast Cancer (clinicaltrials.gov) - Mar 3, 2020
P1b, N=6, Terminated, Sponsor: Spectrum Pharmaceuticals, Inc
No abstract available Trial completion date: Jun 2021 --> Apr 2019 | Active, not recruiting --> Terminated | Trial primary completion date: Jan 2021 --> Apr 2019; Dose limiting toxicity
- poziotinib (HM 78136B) / Spectrum, Hanmi
Poziotinib (STARLIGHT BALLROOM) - Feb 21, 2020 - Abstract #IASLCLCTT2020IASLC_LCTT_55;
- || poziotinib (HM 78136B) / Spectrum, Hanmi
Biomarker, Clinical, P2 data, Journal: Molecular Alterations and Poziotinib Efficacy, a pan-HER inhibitor, in Human Epidermal Growth Factor Receptor 2 (HER2)-positive breast cancers: Combined Exploratory Biomarker Analysis from a Phase II Clinical Trial of Poziotinib for Refractory HER2-positive Breast Cancer Patients. (Pubmed Central) - Feb 16, 2020
In multigene analysis, BC with HER2 CN>8 and intact PIK3CA pathway had significantly longer PFS compared to others (HR: 0.37, 95% CI: 0.21, 0.66, p=0.001), while SNVs in the ERBB3 cytoplasmic domain predicted poor prognosis (HR: 4.28, 95% CI: 1.71, 10.71, p <0.001). In conclusion, HER2 CN amplification, PIK3CA pathway alteration, and ERBB3 cytoplasmic mutation showed predictive roles on clinical outcomes of HER2-positive MBC treated with poziotinib.
- ||| Pozenveo (poziotinib) / Assertio
Enrollment open, HER2 exon 20, Metastases: A Study of Poziotinib in Patients With Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Activating Mutations in Advanced Malignancies (clinicaltrials.gov) - Jan 27, 2020
P2, N=150, Recruiting, Sponsor: Spectrum Pharmaceuticals, Inc
In conclusion, HER2 CN amplification, PIK3CA pathway alteration, and ERBB3 cytoplasmic mutation showed predictive roles on clinical outcomes of HER2-positive MBC treated with poziotinib. Not yet recruiting --> Recruiting
- | Pozenveo (poziotinib) / Spectrum Pharma, Luye Group
Trial completion date, Trial primary completion date: A Mass Balance and Pharmacokinetics Study of 14C-Labeled Poziotinib in Cancer Patients Suitable for Treatment With Poziotinib (clinicaltrials.gov) - Jan 14, 2020
P1, N=10, Recruiting, Sponsor: Spectrum Pharmaceuticals, Inc
Not yet recruiting --> Recruiting Trial completion date: Jun 2020 --> Jun 2021 | Trial primary completion date: Dec 2019 --> Dec 2020
- ||| poziotinib (HM 78136B) / Spectrum, Hanmi
BioCentury - Spectrum’s value halved after poziotinib’s failure in NSCLC cohort https://t.co/YYpiug780M (Twitter) - Dec 28, 2019
- |||| poziotinib (HM 78136B) / Spectrum, Hanmi
Clinical: Cohort 1 of phase II trial of poziotinib in pts with pretreated #EGFR exon 20+ #NSCLC did not meet its primary endpoint. Response rate only 14.8% (DCR 68.7%, DOR 7.4 mos). Results from other cohorts pending. @Exon20Group @EGFRResisters #LCSM #OncoAlert https://t.co/XtXRCGoCZD (Twitter) - Dec 26, 2019
- ||| poziotinib (HM 78136B) / Spectrum, Hanmi
Clinical, P2 data: $SPPI primary endpoint not met in Cohort 1 of Phase 2 clinical trial evaluating Poziotinib in NSCLC (Twitter) - Dec 26, 2019
- ||||| poziotinib (HM 78136B) / Spectrum, Hanmi
Clinical: Pan-Cancer Landscape and Analysis of ERBB2 Mutations Identifies Poziotinib as a Clinically Active Inhibitor and Enhancer of T-DM1 Activity https://t.co/tF5zW4KuNJ (Twitter) - Dec 14, 2019
- | poziotinib (HM 78136B) / Spectrum, Hanmi
Is $SPPI worth $1bn? We could get an answer in December. My @Vantageanalysis take on the upcoming poziotinib results https://t.co/nJ58RO0NsG (Twitter) - Nov 28, 2019
- || poziotinib (HM 78136B) / Spectrum, Hanmi
PK/PD data, Journal: The Design, Synthesis and Preliminary Pharmacokinetic Evaluation of d3-Poziotinib Hydrochloride. (Pubmed Central) - Nov 27, 2019
The structure of d3-poziotinib hydrochloride was confirmed by H-NMR, C-NMR, and high resolution (HR)-MS. Meanwhile, the in vitro microsomal stability experiment showed that d3-poziotinib had a longer half time (t = 4.6 h) than poziotinib (t = 3.5 h).
- | Gilotrif (afatinib) / Boehringer Ingelheim
Review, Journal: Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors in non-small cell lung cancer harboring uncommon EGFR mutations: Focus on afatinib. (Pubmed Central) - Nov 23, 2019
Further data are required to help drive appropriate treatment decisions in patients whose tumors harbor these uncommon EGFR mutations. To see an abstract video summarising the content of the paper, please visit http://usscicomms.com/oncology/masood/seminars-in-oncology/.
- | poziotinib (HM 78136B) / Spectrum, Hanmi
My dad started this drug about 2 weeks ago, how do you evaluate the effectiveness of poziotinib? (Twitter) - Nov 21, 2019
- | poziotinib (HM 78136B) / Spectrum, Hanmi
One major caveat about poziotinib, however exciting it might seem: $SPPI bought it from Hanmi #Jefferies19 (Twitter) - Nov 21, 2019
- |||| poziotinib (HM 78136B) / Spectrum, Hanmi
Clinical: This is the MD Anderson single-centre poziotinib study. 43% in EGFR exon 20 mutant NSCLC, per #WCLC2018. Presumably $SPPI expects something a little lower in Zenith20 #Jefferies19 (Twitter) - Nov 21, 2019
- || poziotinib (HM 78136B) / Spectrum, Hanmi
Major catalyst for $SPPI: data on cohort 1 of poziotinib's Zenith20 trial due in December #Jefferies19 (Twitter) - Nov 21, 2019
- |||| Pozenveo (poziotinib) / Assertio
New P2 trial, HER2 exon 20, Metastases: A Study of Poziotinib in Patients With Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Activating Mutations in Advanced Malignancies (clinicaltrials.gov) - Nov 20, 2019
P2, N=150, Not yet recruiting, Sponsor: Spectrum Pharmaceuticals, Inc
- || Completely agree, look data for poziotinib, nazartinib, pyrotinib, TAS6417, TAK788, tarloxotinib, luminespib, WZ8040, WZ4002, and profound data around combos (Twitter) - Oct 10, 2019
- | poziotinib (HM 78136B) / Spectrum, Hanmi
Journal: Activity of a novel HER2 inhibitor, poziotinib, for HER2 exon 20 mutations in lung cancer and mechanism of acquired resistance: An in vitro study. (Pubmed Central) - Oct 2, 2019
We identified the secondary C805S at the covalent binding site of HER2 to poziotinib as a potential mechanism of acquired resistance. HSP90 inhibitors might be a therapeutic strategy for the C805S secondary mutation.
- poziotinib (HM 78136B) / Spectrum, Hanmi, Tagrisso (osimertinib) / AstraZeneca
Discovery of selective and potent EGFR kinase inhibitors for exon20 insertion mutations (Board 2: Level 2 - Hall D) - Sep 18, 2019 - Abstract #AACRNCIEORTC2019AACR_NCI_EORTC_223;
Finally, in several Ex20Ins patient-derived xenograft models, the candidate inhibitors induced tumor regression as strong as Poziotinib and increased survival rates along with minimal weight loss. These novel small molecule compounds inhibiting EGFR exon 20 insertion mutations will provide future therapeutic options for patients with this molecular subtype of NSCLC.
- |||| poziotinib (HM 78136B) / Spectrum, Hanmi
Understanding poziotinib resistance in EGFR exon 20 by @MDAndersonNews group. They find EGFR T790M among other mechanisms #WCLC19 (Twitter) - Sep 8, 2019
- |||| poziotinib (HM 78136B) / Spectrum, Hanmi
Preclinical: Robichaux: Acquired resistance to poziotinib: 20 matched pre/post plasma showed wide variety of on target mechs incl T790M and C797S, and off target bypass tracks and EMT. No one dominant mech. No info on SCLC transform since ctDNA testing only. @Exon20Group #WCLC19 #LCSM (Twitter) - Sep 8, 2019
- |||||| poziotinib (HM 78136B) / Spectrum, Hanmi
Heterogeneity: #WCLC19 Jacqulyne Robichaux presents early data on mechanisms of resistance to poziotinib. Notes point mutations (inc T790M), EGFR amplification, PIK3CA mutations. Fairly heterogeneous and similar to other TKIs. #OncoAlert (Twitter) - Sep 8, 2019
- | Pozenveo (poziotinib) / Assertio
New P2 trial, EGFR exon 20, HER2 exon 20, Metastases: Poziotinib in Patients With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation (clinicaltrials.gov) - Aug 4, 2019
P2, N=114, Recruiting, Sponsor: Hanmi Pharmaceutical Company Limited
- ||| poziotinib (HM 78136B) / Spectrum, Hanmi
Platinum-based chemo Is the right choice. No data r available a/ the role of ICI in this biological cluster. Poziotinib in 1L? No, based on available PFS and high tox. Combo chemo + ICI➡️2L poz? maybe not the right choice considering the potentially cumulative lung tox #lcsm (Twitter) - Jul 30, 2019
- ||| poziotinib (HM 78136B) / Spectrum, Hanmi
Clinical: My thoughts are: 1. Poziotinib is very toxic for a very simptomatic patient 2. iO does not work very well in driver mutations and never smokers 3. CTIo not yet reimbursed...🤦♀️ (Twitter) - Jul 29, 2019
- | Pozenveo (poziotinib) / Spectrum Pharma, Luye Group
Enrollment open, Trial completion date, Trial initiation date: A Mass Balance and Pharmacokinetics Study of 14C-Labeled Poziotinib in Cancer Patients Suitable for Treatment With Poziotinib (clinicaltrials.gov) - Jul 28, 2019
P1, N=10, Recruiting, Sponsor: Spectrum Pharmaceuticals, Inc
These novel small molecule compounds inhibiting EGFR exon 20 insertion mutations will provide future therapeutic options for patients with this molecular subtype of NSCLC. Not yet recruiting --> Recruiting | Trial completion date: Mar 2020 --> Jun 2020 | Initiation date: Mar 2019 --> Jul 2019
- | Pozenveo (poziotinib) / Assertio
Enrollment change, Trial completion date, Trial primary completion date, EGFR exon 20, HER2 exon 20, Metastases: ZENITH20: Phase 2 Study of Poziotinib in Participants With NSCLC Having EGFR or HER2 Exon 20 Insertion Mutation (clinicaltrials.gov) - Jul 26, 2019
P2, N=554, Recruiting, Sponsor: Spectrum Pharmaceuticals, Inc
Not yet recruiting --> Recruiting | Trial completion date: Mar 2020 --> Jun 2020 | Initiation date: Mar 2019 --> Jul 2019 N=314 --> 554 | Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Jun 2022 --> Mar 2023
- || pyrotinib (HTI-1001) / Jiangsu Hengrui Medicine, poziotinib (HM 78136B) / Spectrum, Hanmi, Nerlynx (neratinib) / Puma
Pyrotinib, Poziotinib, and Neratinib to the rescue! (Twitter) - Jul 25, 2019