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Get filing alertsOlema reports early tumor shrinkage in Phase 1 trial of cancer drug OP-3136
Filed May 21, 2026 · Period ending May 21, 2026 · ~1 min read
Key Changes
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high
Phase 1 study of OP-3136 showed tumor shrinkage in 13 of 19 evaluable patients across three cancer types, with 3 partial responses in heavily pretreated patients who had exhausted standard treatments.
Item 8.01: Press Release verify on EDGAR → -
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Drug was well-tolerated with no dose-limiting toxicities up to 45 mg daily and no severe adverse events; most common side effect was taste changes (81%), with no treatment discontinuations due to safety issues.
Item 8.01: Safety Data verify on EDGAR → -
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Eleven patients remain on treatment including one for 62 weeks, suggesting potential durability; study enrolled patients with advanced breast cancer, prostate cancer, and lung cancer resistant to prior therapies.
Item 8.01: Efficacy Signals verify on EDGAR → -
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Drug demonstrated proof of mechanism with sustained reduction in its molecular target (KAT6), and showed predictable, dose-proportional exposure with drug levels exceeding efficacy targets at 6 mg and above.
Item 8.01: Pharmacology verify on EDGAR →
Summary
Olema Pharmaceuticals disclosed preliminary Phase 1 results for OP-3136, an experimental cancer drug targeting the KAT6 enzyme, showing early signs of activity in patients with advanced cancers who had run out of standard treatment options.
In a 32-patient dose-escalation study across breast, prostate, and lung cancers, the drug demonstrated tumor shrinkage in two-thirds of evaluable patients and achieved partial responses in three patients. The safety profile was favorable with no dose-limiting toxicities and manageable side effects, primarily taste changes.
For retail investors, this represents an important early validation of Olema's second pipeline asset beyond its lead breast cancer program. Phase 1 trials primarily test safety rather than efficacy, so observing tumor responses at this stage—particularly in heavily pretreated patients—is encouraging but preliminary. The data will be presented at the American Society of Clinical Oncology meeting on May 30, 2026. Watch for the full ASCO presentation and management commentary on next steps, including whether Olema will advance OP-3136 into Phase 2 trials and in which cancer indication. The durability of responses and whether the company can identify biomarkers to select patients most likely to benefit will be critical factors determining the drug's commercial potential.
Section-by-Section Diff
Event · Item 7.01 — Regulation FD Disclosure
Olema announced preliminary Phase 1 clinical data for OP-3136, a KAT6 inhibitor, via press release.
Added in current filing · verify on EDGAR →
On May 21, 2026, Olema Pharmaceuticals, Inc. (the “Company”) issued a press release announcing preliminary clinical data from its Phase 1 study of OP-3136, a potent lysine acetyltransferase 6 (KAT6) inhibitor.
The company disclosed preliminary clinical trial results for OP-3136, an experimental drug targeting KAT6. This is an early-stage Phase 1 study, meaning the data likely focuses on safety and dosing rather than efficacy. The actual clinical results are in the press release exhibit, not detailed in the 8-K body itself.
Event · Item 8.01 — Other Events
Item 8.01 — Other Events filed; see Key Changes for terms.
Added in current filing · verify on EDGAR →
on May 21, 2026, the Company announced preliminary clinical data from its Phase 1 study of OP-3136. The Phase 1 study evaluates dose escalation followed by dose expansion of OP-3136 in patients with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced breast cancer (ABC), metastatic castration-resistant prostate cancer (mCRPC), and metastatic non-small cell lung cancer (mNSCLC). In Part 1A, OP-3136 monotherapy was administered orally once daily in 28-day cycles across dose levels from 2-45 mg. As of the March 2, 2026 data cut-off, 32 heavily pretreated patients who became resistant or intolerant to standard of care treatments were enrolled in this cohort.
Olema disclosed preliminary results from its Phase 1 dose-escalation study of OP-3136, an investigational cancer therapy. The study enrolled 32 heavily pretreated patients across three cancer types who had become resistant or intolerant to standard treatments. Data will be presented at the American Society of Clinical Oncology Annual Meeting on May 30, 2026.
Added in current filing · verify on EDGAR → · paraphrased
OP-3136 monotherapy was well-tolerated with no dose-limiting toxicities observed across the evaluated daily dose range up to 45 mg per day orally. Most treatment-related adverse events (TRAEs) were grade 1 or 2; no grade 4 or 5 TRAEs were observed. TRAEs were manageable with dose modifications; no treatment discontinuations occurred due to TRAEs. The most common TRAEs were dysgeusia (81% any grade; 56% grade 1, 25% grade 2), anemia (38% any grade; 6% grade 3), and neutropenia (34% any grade; 28% grade 3).
The drug showed a favorable safety profile with no dose-limiting toxicities up to 45 mg daily and no severe (grade 4 or 5) treatment-related adverse events. Most side effects were mild to moderate, with taste changes (dysgeusia) being most common at 81%, and no patients discontinued treatment due to adverse events. This safety data is critical for advancing the drug to later-stage trials.
Added in current filing · verify on EDGAR →
Among 19 response-evaluable patients across dose levels and tumor types, tumor shrinkage was observed in 13 patients; partial responses were observed in 3 patients with measurable disease, with 2 confirmed PRs and 1 unconfirmed PR. ... The longest duration of treatment is 62 weeks. ... 11 patients remain on treatment, including 9 with ABC and 2 with mCRPC.
Early efficacy signals showed tumor shrinkage in 13 of 19 evaluable patients, with 3 partial responses including 2 confirmed. Eleven patients remain on treatment with one patient continuing for 62 weeks, suggesting potential durability. These preliminary efficacy results in heavily pretreated patients support continued development of OP-3136.
Added in current filing · verify on EDGAR →
Across all doses tested, OP-3136 demonstrated rapid, sustained, and significant reduction in levels of lysine 23 of histone H3, a direct target of KAT6, consistent with on-target KAT6 inhibition.
The drug demonstrated proof of mechanism by showing sustained reduction in its direct molecular target (lysine 23 of histone H3), confirming that OP-3136 is hitting its intended biological target (KAT6 inhibition) at the doses tested. This pharmacodynamic evidence supports that observed clinical effects are due to the intended mechanism of action.
Added in current filing · verify on EDGAR →
OP-3136 exhibited predictable, dose-proportional plasma exposure across all doses tested. ... At doses of 6 mg and above, steady-state concentrations exceeded efficacy targets based on preclinical models.
The drug showed predictable, dose-proportional exposure in the bloodstream, and at doses of 6 mg and higher, drug levels exceeded the concentrations predicted to be effective based on preclinical studies. This pharmacokinetic profile supports selecting optimal doses for future trials and suggests the drug behaves predictably in humans.
Event · Item 9.01 — Financial Statements and Exhibits
Olema Pharmaceuticals filed an 8-K attaching a press release dated May 21, 2026; no material business event disclosed in the filing body.
Added in current filing · verify on EDGAR →
Press Release, dated May 21, 2026, of Olema Pharmaceuticals, Inc.
The 8-K references an attached press release dated May 21, 2026. The filing body itself contains no disclosure of the press release content or the underlying event being announced. Without access to Exhibit 99.1, the materiality and nature of the disclosure cannot be determined from this filing.
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