Fugitive42

$IOVA Fred hit it out of the park! This company is a juggernaut! We don't have enough shares is the understatement of the year. Load up kids its trading with absolutely nothing priced in.

$IOVA Wells Fargo easy read. Company Update — October 29, 2026 Biotechnology Iovance Biotherapeutics Updated 2L mNSCLC Data with Promising Biomarker-Enrichment Strategy Our Call We note 59% ORR in KRAS WT/HER2 WT/ever-smokers strengthens TIL’s value proposition in 2L nsq-mNSCLC. Overall pop’s ORR held at 25%, mDOR was immature (~1 yr), and reduced LD led to improved safety, cutting Gr5 AE in half & cutting hosp. days >50%. We think today’s stock weakness could be due to concerns regarding durability and whether reduced lymphodepletion (LD) impacted DOR. We note if TIL expansion was impaired (from insufficient LD), ORR probably would have been impacted, which we note is not the case. We therefore expect mature DOR data to still be positive and clearing our experts’ bar of 12 months. With final data-cut expected in early ’27, we expect focus for the NSCLC program to rotate to FDA discussions and BLA filing.

$IOVA The November 2025 update was on 39 patients who already had a median of 25.4 months of follow-up (mDOR not reached). The October 2026 update added roughly 30 more patients, bringing the total to 69. Those newer patients have much shorter time on study, so they haven’t had the chance to show long duration yet. When you mix them in, the overall current look of the swimmer plot gets pulled shorter (Fred’s “about a year” comment on the immature data). The longer tails from the earlier patients are still in the plot, but the newer, shorter-followed responses drag the present visual median down until more time passes. That’s normal when you expand a dataset with recent enrollees. It will be 2 years mdor when data is mature. Talk about jumping the gun on selling shares! Idiots!

$IOVA Fred Vogt: "Right now, if you estimated from that swimmer's plot where we'd be, we'd be at about a year, but I need to stress that the data is immature and data is still coming in and that we would expect to grow over time, and there's some patients that are coming in right now, obviously, that are responding. You really can't assess durability at this stage until the data's finally done. We're also in the middle of IRC reads and a lot of other things that will affect the outcome." "We are confident that the product is durable, and we'll show durability comparable to what we would expect from TIL therapies. On the broader question of whether FDA would accept this filing, we think a 25% response rate durable with a one-time treatment in this population should be approvable, and we think the FDA should accept it and should go forward." This is why the November 2025 cut on the earlier 39 patients still showed mDOR not reached at 25.4 months of median follow-up, while the larger October 2026 cut (69 patients) currently looks shorter on the swimmer plot. The newer patients simply haven’t been followed long enough yet to match the duration already seen in the earlier group. Once the final data cutoff happens in early 2027 and more follow-up accrues on the full 80-patient set, the median can still lengthen if the ongoing responses continue. People dont understand how mdor works and sold today. LMFAO!

$IOVA Who you going to listen to? Scare mongers on X or from the horses mouth? Fred Vogt (Interim CEO and President, Iovance Biotherapeutics): We continue to move forward towards the sBLA submission in 2027, and we will have further updates along the way, including on our confirmatory trial plan. As I mentioned, we expect approximately 80 non-squamous, non-small cell lung cancer patients to be included in the final data set for the sBLA. Today's data update represents nearly all of the patients in the expected data package. Our internal teams are focused on preparing for the sBLA submission. Independent review committee assessments, FDA discussions, and other pre-submission activities, including confirmatory trial preparation, are also ongoing. We look forward to completing enrollment in Cohorts 1 and 2 shortly and are confident in the road ahead in previously treated non-squamous metastatic non-small cell lung cancer, which earned FDA's Fast Track designation on the strength of our clinical data and represents an area of high unmet medical need.

$IOVA Back to reality. 2L non-squamous NSCLC after PD-1 Current standard of care (docetaxel) • ORR: 13% • mDOR: 5.6 months Amtagvi (lifileucel) – IOV-LUN-202 • ORR: 24.6% (17/69) • mDOR: not reached at prior 25.4-month median follow-up • Ongoing responses past 2–4 years on the swimmer plot • Management today: currently looks 18+ months reasonable Roughly double the response rate and meaningfully longer durability so far, with a one-time treatment. Which would you take? Why would the FDA say no? Not happening. Sbla to be filed in 2027. Its a superior treatment!

Standard 2L chemo (docetaxel) in post-PD-1 non-squamous NSCLC has historically shown 13% ORR and mDOR of 5.6 months. Docetaxel + ramucirumab is a bit better on ORR in some post-ICI datasets but mDOR still typically lands in the 5–6 month range. For Amtagvi (lifileucel) in the IOV-LUN-202 lung trial, the prior interim update had mDOR not reached after 25.4 months of median follow-up. Today’s update says durability remains consistent with that; the new swimmer plot still shows ongoing responses (including some past 2+ years). Management noted the data are still immature and currently look closer to 18 months on the plot, with room for the median to lengthen with more follow-up. So vs the current approved 2L standard, even a 18 month mDOR would already be roughly triple, and the long tails visible in the deck go well beyond that. That’s the durability argument people are watching.

$IOVA The last 11 patients have a real but bounded impact. Holding the mid-20s ORR requires a response rate in this final group similar to what has already been seen. A cluster of non-responders pulls the final number into the low 20s and strengthens the case for leaning on the precision (POSITILITY) path; a few extra responses keeps the broader population story intact for the planned 2027 sBLA. The company will have the final cutoff and more mature durability data in early 2027 before the actual filing. If the remaining patients happen to be enriched for the KRAS wild-type / HER2 wild-type / ever-smoker subgroup (the one that has been driving most responses so far), the overall ORR can tick up even with a modest number of new responses. If they are mostly KRAS-mutant, the opposite happens. The final dataset will also have more follow-up. A lower ORR with longer, cleaner durability (or more ongoing responses) is still usable for accelerated approval in this setting; a higher ORR with short durability is less attractive. Management has already said duration data are still immature.

$IOVA HCW maintains $20 price target.

$IOVA What we might hear about today. The poster from ESMO supports expanding who is considered for TIL therapy beyond the narrow clinical/histologic checklist used in the registrational trial. Manufacturing itself reinvigorates the pTR cells. That opens the door to: Patients with more exhausted tumors Patients with Treg-high / checkpoint-resistant biology Potentially other histologies or lines of therapy that currently fall outside the trial criteria In other words, the pool of patients who could reasonably be offered lifileucel gets larger. This is the mechanism behind “potentially broadening the strategy”. Selecting for sufficient reinvigorated pTR content in the final product could push the ORR from the mid-20s into the 30s or low-to-mid 40s in that enriched group, provided the trend in the poster holds in the full dataset. Today’s webcast is the first chance to see whether they quantify this relationship (e.g., ORR by pTR tertile or a proposed cutoff).

$IOVA Market lost its mind over Moderna’s $MRNA personalized melanoma vaccine , still years from approval and only for a small subset of high risk resected patients (adjuvant recurrence prevention). Meanwhile Iovance is already commercial with TIL therapy in melanoma and has positive registrational lung data dropping tomorrow in previously treated nonsquamous mNSCLC. TAM there is massive (hundreds of thousands of addressable patients globally). Lung cancer has been a Phase 3 graveyard the last two years. A real win here should matter a lot more than another adjuvant melanoma story.

$IOVA Lung trial failures (last 2 years) AstraZeneca → volrustomig (NSCLC, PD-L1 low): Phase 3 eVOLVE-Lung02 stopped for futility; unlikely to beat Keytruda + chemo on PFS/OS (~Aug 2026). AstraZeneca → ceralasertib + Imfinzi (previously treated NSCLC): Phase 3 LATIFY missed OS vs docetaxel (~Dec 2025). Pfizer → sigvotatug vedotin (ADC, pretreated nonsquamous NSCLC): Phase 3 SigVie-002 missed OS vs docetaxel (~June 2026). Jazz / PharmaMar → Zepzelca (lurbinectedin, relapsed SCLC): Phase 3 LAGOON missed OS (mono and combo); led to withdrawal of second-line indication (~June 2026). Gilead / Merck → sacituzumab govitecan + Keytruda (1L PD-L1-high NSCLC): Phase 3 EVOKE-03/KEYNOTE-D46 missed PFS; no OS benefit; trial discontinued (~2026). Immutep → eftilagimod alfa + Keytruda + chemo (1L NSCLC): Phase 3 TACTI-004 stopped for futility (~March 2026). Merck / Daiichi → ifinatamab deruxtecan (I-DXd, relapsed SCLC): Withdrew accelerated approval filing (Phase 2 data insufficient); Phase 3 had partial hold for ILD deaths (~2025–2026). Merck / Daiichi → patritumab deruxtecan (HER3-DXd, EGFR-mutated NSCLC): Phase 3 HERTHENA-Lung02 missed OS; withdrew application (~2025). Roche → Tecentriq (periadjuvant NSCLC): Impower-030 failed primary EFS (non-significant due to design/stats) (~2026). These are the main high-profile Phase 3 primary-endpoint misses or early terminations in lung cancer from the period. Not every smaller or mid stage miss is included. Iovance steps to the plate.

$IOVA IOV-LUN-202 is an open-label, non-randomized, multi-cohort Phase 2 study. What that means for visibility: Iovance (and the investigators) can see safety data, manufacturing success rates, and investigator-assessed responses as they occur. The primary endpoint for the key registrational cohorts is still objective response rate by an independent review committee (IRC) using RECIST v1.1, which provides a layer of independent confirmation. Secondary endpoints (duration of response, disease control rate, PFS, OS, etc.) are also tracked over time, so durability trends become visible to the sponsor well before a formal data cut is locked and presented. Frederick (“Fred”) Vogt, Interim CEO, on the Q2 2026 earnings call (August 6, 2026 “The lung is looking very positive right now. We feel very good about where we stand with the study and we will have a lot, I think, to say about that. I know that’s a very key thing for investors and I really urge everybody to watch carefully as we talk about that, and maybe even more than what people are expecting in this space.” “We’re seeing very strong durability, I think very similar in overall outcome to what we saw in melanoma. It’s effectively the same type of product. When we get a response, it’s usually pretty durable.”

$IOVA The ESMO 2026 poster on IOV-LUN-202 is the setup for tomorrow’s webcast. Poster 4359P (“Enrichment of putative tumor reactive clones in NSCLC patients responding to Lifileucel”) used single cell analysis on patients from the registrational trial. Key findings: Baseline tumor content of putative tumor reactive (pTR) T cells was similar between responders and non responders. In the infused lifileucel product, non responders tended to have fewer pTR clones. Those clones were reinvigorated in the product (lower exhaustion, higher effector and proliferative states). Persistence was seen in blood after infusion. This is exactly the type of data that can support a precision strategy, identifying patients more likely to benefit so the response rate in a selected subset can be higher than the all comers number. Last year’s interim showed 25.6% ORR in a broad post-chemo/post-PD-1 nonsquamous population. An enriched subset could look meaningfully better. Tomorrow’s webcast (Oct 29, 8:30 a.m. ET) covers positive results from the IOV-LUN-202 registrational cohorts in previously treated nonsquamous mNSCLC and an update on precision based medicine opportunities for the TIL platform in lung cancer. The poster and the webcast are talking about the same program IMO.

$IOVA Anyone saying frontline melanoma is several years away is wrong. TILVANCE-301 has dual primary endpoints of ORR and PFS under an FDA agreed design, with a planned early interim analysis on ORR that supports accelerated approval / sBLA for the frontline indication. Full approval follows from the final PFS analysis. That interim ORR path was built into the study from the start so a positive readout can open a regulatory filing well before mature PFS data, not years later. Company materials have described this early interim as intended for an sBLA. Supported by the final Phase 2 data from IOV-COM-202 Cohort 1A (ESMO 2026): 62.5% ORR and 29.2% CR with one time lifileucel plus pembrolizumab in ICI naive advanced melanoma. Educated guess on timing for the interim ORR readout 2027 (likely mid-to-late), based on enrollment starting mid-2023, N=670, and the “early interim” structure.

$IOVA UPS and DDLS barely respond to frontline chemo. Options after that are even worse. These scans show clear tumor shrinkage 6 months after a single lifileucel infusion in pretreated patients. A 40–50% response rate with durable responses in heavily pretreated UPS/DDLS is stronger than what most frontline chemo regimens deliver in these subtypes. If the signal holds in a larger trial, it becomes a legitimate candidate to move earlier — either as frontline in selected patients or after a short chemo run in. One treatment. High unmet need.

$IOVA Iovance’s case for a Commissioner’s National Priority Voucher (CNPV) looks stronger once you look at the actual oncology awards. The program has already given CNPVs to high priced oncology products, Jemperli, Rasonque ($480k/year), Hernexeos, and the Tecvayli combo, primarily for innovative breakthroughs and large unmet need, not because they were cheap. Amtagvi is the first FDA approved cell therapy for any solid tumor. The pipeline has Fast Track designations in NSCLC and UPS/DDLPS sarcoma, with strong early data in settings where standard of care is weak. Manufacturing is fully owned and U.S.-based at the iCTC in Philadelphia. That combination lines up with how the FDA has actually selected oncology CNPVs so far.

$IOVA The FDA just cleared GSK’s Jemperli (dostarlimab) for dMMR/MSI-H locally advanced rectal cancer roughly four months ahead of its PDUFA date. Priority Review + the new Commissioner’s National Priority Voucher (CNPV) pilot program did the work. CNPV is designed to cut reviews to a 1–2 month target for products that address large unmet needs, represent genuine innovative breakthroughs, or strengthen domestic manufacturing. It applies to biologics, is non transferable, and companies can submit statements of interest now. This maps directly onto Iovance ($IOVA). Amtagvi (lifileucel) is already the first FDA approved TIL cell therapy for a solid tumor. The company holds Fast Track designations in non-squamous NSCLC (IOV-LUN-202) and soft tissue sarcomas (UPS/DDLPS via SARATOGA), is actively engaging the FDA on an expedited path in endometrial cancer, and operates fully owned, centralized U.S. manufacturing at its Philadelphia Cell Therapy Center. These are precisely the kinds of settings the CNPV was built for: post chemo/IO populations with limited options, novel modality with durable responses, and domestic manufacturing capacity already in place. A voucher wouldn’t just speed one filing, it would reinforce the platform thesis across multiple large solid-tumor opportunities. The regulatory environment is clearly open to accelerating high impact oncology assets. Iovance is positioned to take advantage of it. Article: superpower.com/blog/dostarli…

$IOVA Worth listening to. Actual experts discussing how the field is evolving — a refreshing change from some of the low effort content floating around. Fantastic new ASTCT Talks episode on the evolution of TIL therapy for solid tumors. Hosted by Dr. Daniel Olson (University of Chicago Medicine recently recognized as #1 in volume of TIL infusions), with Dr. Stephanie Goff (NCI) and Dr. Allison Betof (Stanford Medicine). They walk through how TIL therapy has matured from its pioneering days at the NCI to FDA approved treatment in advanced melanoma and, importantly, how clinicians are refining delivery for better outcomes. One of the clearest shifts: experience is showing that fewer doses of IL-2 (rather than pushing to a maximum of 6) can reduce toxicity while maintaining or even improving results and patient tolerance. Great practical discussion from leaders who are actively shaping how this treatment is given in the real world. Listen here: astct.org/Nucleus/Article/po…

$IOVA The upfront period with lifileucel is intensive (tumor harvest, lymphodepleting chemo, cell infusion, short course of IL-2). But after that, many patients are done with the cell therapy itself. They are not committed to indefinite dual-checkpoint infusions or the cumulative risk of chronic immune-related side effects that can last for years on continuous PD-1 therapy. For a lot of patients, the alternative is not a gentle outpatient regimen with no downside. It is: Ongoing infusions every few weeks for months or years, A meaningful chance of long-term or permanent side effects from checkpoint inhibitors, And still a substantial risk of progression within 10–12 months on current dual-checkpoint standards. If the phase 3 confirms a median PFS near 20 months (or longer) with a high complete-response rate, many patients — especially those who are otherwise fit — would view the short-term intensity as a trade they are willing to make for a one-time treatment that offers a better shot at durable control and the possibility of stopping therapy sooner. Avoiding progression or death is the dominant goal; the logistics and short-term toxicity are secondary for a lot of people facing metastatic melanoma. The regimen is harder in the first few weeks. It is not harder over the full course of disease compared with continuous dual immunotherapy for many patients. That distinction matters. IL-2 is already given flexibly in practice (typically 2–6 doses based on what the patient can tolerate), and post hoc data from the pivotal trial showed no clear loss of response rate or durability with fewer doses. Combined with reduced dose lymphodepletion regimens now being tested and used in higher risk patients, the upfront intensity of the regimen is more adjustable than the original full dose protocol suggested.