TG Therapeutics' TG-1101 + Imbruvica shows 95% response rate in high risk leukemia in updated results from mid-stage trial Jun 18 2015, 12:17 ET | About: TG Therapeutics, Inc. (TGTX) | By: Douglas W. House, SA News Editor Contact this editor with comments or a news tip Updated data from a Phase 2 study evaluating TG Therapeutics' (TGTX +17.6%) investigational TG-1101 (ublituximab) in combination with ibrutinib (Pharmacyclics' (NYSE:ABBV) Imbruvica) in patients with relapsed/refractory chronic lymphocytic leukemia (CLL) showed a 95% overall response rate (n=19/20) with 20% (n=4/20) achieving MRD (minimal residual disease) negativity in CLL patients considered high risk. The data were presented at the 13th International Congress on Malignant Lymphoma in Lugano, Switzerland.In 40 evaluable patients, 88% (n=35/40) achieved an objective response and 10% (n=4/40) achieved nodal reductions of 20 - 55% without disease progression.The combination of TG-1101 and ibrutinib was well tolerated in the 44 patients treated. The most common Grade 3 or 4 (severe/life threatening) adverse events observed were neutropenia (11%) (n=5/44), anemia (11%) (n=5/44) and infusion-related reactions (7%) (n=3/44).A Phase 3 study, called GENUINE, comparing the combination of TG-1101 and ibrutinib to ibrutinib alone in previously-treated high risk CLL patients is underway. Total enrollment will be ~330. Results will support a Biologics License Application (BLA) for accelerated approval of TG-1101. The study's completion date is projected to be August 2018.
Roth Capital analyst Joseph Pantginis reiterated a Buy rating and $33 price target on TG Therapeutics (NASDAQ: TGTX) after they received updated data from the Phase II TG-1101/Imbruvica combination study in CLL patients.
"The high-risk group showed a 95% response rate, compared to the 60-65% expectation for Imbruvica alone." Pantginis notes. "This high-risk group also represents the targeted patient in the ongoing Phase III GENUINE study and we believe these Phase II data continue to act as a strong proxy for a successful outcome of GENUINE."
FWIW...NVAX is another nice small bio that had a big selloff. Their CEO was on Mad Money last week and they had the normal pop associated with it. The stock immediately sold back off so while the air time might bring a bit of awareness and some buying, it is usually very short-lived.
Firing on All Cylinders –Phase III Enrolling Ahead of Schedule and Positive Interim Analysis Firing on All Cylinders –Phase III Enrolling Ahead of Schedule and Positive Interim Analysis
Raymond James / May 23, 2017
Recommendation: We are maintaining our Strong Buy rating for TG Therapeutics. This morning, the company announced positive interim results from the ongoing Phase III UNITYCLL study, which allowed for the elimination of two single-agent arms as well as the continuation of the combination arms given that no safety concerns were identified. While we had been expecting a successful interim analysis, the results came in a little earlier than expected, which, in our opinion, indicates an accelerated accrual pace. In addition, we note two additional positives: 1) Full enrollment for the UNITY-CLL study is now expected to complete by year-end (versus 1Q18 as previously guided), with ORR data from the pivotal study expected in 3Q18; and 2) TGR-1202 appears to be safe among treatment naïve CLL patients so far. With multiple readouts anticipated in the next 12 months, the ongoing progress from several registrational trials, the potential to expand and create value in the multi-billion dollar multiple sclerosis (MS) market, and a cash position of around $109.5 million as of 1Q17, we continue to recommend shares of TGTX to risk-tolerant investors.
A successful first interim analysis. After reviewing the overall response rate (ORR) data from approximately 50 patients in each of the two single-agent arms (TGR-1202 or TG- 1101) of the UNITY-CLL study, the independent Data Safety Monitoring Board (DSMB) concluded that the contribution from either agent has been established, recommending the company stop enrollment into these two arms. In addition, the DSMB also recommended the continuation of the UNITY-CLL study without modifications after identifying no safety issues from 270+ patients treated on study as of the data cut-off date, which suggests that approximately 170+ patients have been treated with eitherTG- 1101 plus TGR-1202 or obinutuzumab plus chlorambucil. Recall, the study is designed to enroll a total of 450 patients.
Additional incremental positives. According to the company, full enrollment is now expected to complete by the end of 2017 (previously guided 1Q18), which, in our opinion, indicates that there is still a strong demand for new therapies in the CLL space despite a number of existing treatment options including ibrutinib. Given the accelerated enrollment, the company expects to provide ORR data from the entire study in 3Q18, which could be utilized to support an accelerated approval application. In addition, TGR- 1202, a PI3K delta inhibitor, appears to be safe among more than 60 front line patients treated for more than six weeks with TGR-1202 alone or in combination with TG-1101, which, in our opinion, continues to showcase TGR-1202’s superior safety profile as compared to idelalisib. Recall, the clinical development of idelalisib for treatment naïve CLL patients was discontinued because of serious safety issues including deaths.
Under: Been on the sidelines for a bit holding (building) cash. Now that "BIGLEY" has rolled out the tax plan its time to jump in.
Dec 21, 2017 19:06:02 GMT -6
martyc: Looks like you are buying Msft again!
Dec 15, 2017 11:23:29 GMT -6
martyc: The news that Trump called Rupert to congratulate him sure seems to indicate that this is heading to approval
Dec 15, 2017 11:22:23 GMT -6
Under: DIS finally getting some traction.?
Dec 14, 2017 17:08:45 GMT -6
martyc: I took an entry level position in DIS. Will add eventually to overweight when it becomes clearer that the deal will go thru. Can't believe how well positioned they will be. 60% Hulu. 20% of content watched on NFLX they can pull. More in thread
Dec 14, 2017 11:05:16 GMT -6
Under: Great posts on $DIS
Dec 13, 2017 17:50:49 GMT -6
Under: $ROKU Citron on a war path.
Nov 28, 2017 15:11:20 GMT -6
Under: $HAS takeover bid for $MAT?
Nov 10, 2017 16:16:07 GMT -6
martyc: Not looking like the market will provide any discounted opp for SGMO. Call was just too professional and all signs indicate they are on a great path for commercialization. Happy with core but wish I had some trading shs
Nov 10, 2017 9:04:05 GMT -6
martyc: For anyone looking to find an entry point into SGMO, I'm almost hoping is sells off in next few days so I can add more. They are really clicking but the fact they haven't signed new deals might cause some to exit. Watching as I have room for trading shs
Nov 9, 2017 18:28:09 GMT -6
martyc: Been an interesting ride so far. I figured the Bears would be about this good but hoped the O wouldn't look so lame. Another building yr but still possible to get to 8-8 IMO
Nov 9, 2017 18:26:08 GMT -6
Under: whats up with your Bears this year Marty?
Nov 9, 2017 17:35:25 GMT -6
martyc: Hope you were long ROKU. I wanted to see Q first so missed out
Nov 9, 2017 7:08:53 GMT -6